Free Amended Complaint - District Court of California - California

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 1 of 16

1 Henry C. Su (SBN 211202; [email protected]) Katharine L. Altemus (SBN 227080; [email protected]) 2 HOWREY LLP 1950 University Avenue, 4th Floor 3 East Palo Alto, California 94303 Telephone: (650) 798-3500 4 Facsimile: (650) 798-3600 5 Robert Ruyak Matthew Wolf 6 Marc Cohn HOWREY LLP 7 1229 Pennsylvania Avenue, NW Washington, DC 20004 8 Telephone: (202) 783-0800 Facsimile: (202) 383-6610 9 Attorneys for Plaintiff 10 HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC LP 11 12 13 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION Case No. C08 00133 RMW AMENDED COMPLAINT FOR PATENT INFRINGEMENT, LANHAM ACT VIOLATIONS, AND STATE UNFAIR COMPETITION SEEKING DAMAGES AND INJUNCTIVE RELIEF

14 HOLOGIC, INC., CYTYC CORPORATION, and HOLOGIC LP, 15 Plaintiff, 16 vs. 17 SENORX, INC., 18 Defendant. 19 20 21 22 23 24 25 26 27 28
HOWREY LLP

DEMAND FOR JURY TRIAL

AND RELATED COUNTERCLAIMS.

Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 2 of 16

1

Plaintiffs Hologic, Inc., Cytyc Corporation, and Hologic L.P. (together, "Hologic"), by their

2 attorneys, complain against SenoRx, Inc. ("SenoRx"), and allege as follows: 3 4 1. NATURE OF THE ACTION Hologic brings this action to seek damages and injunctive relief arising out of the

5 infringement by SenoRx of U.S. Patent Nos. 5,913,813, 6,413,204, and 6,482,142 (together, the 6 "Patents-In-Suit," attached hereto at Exhibits A, B, and C, respectively), and for related acts of false 7 advertising. 8 2. Plaintiff Hologic, Inc. is a Delaware corporation with a place of business at 35 Crosby

9 Drive, Bedford, Massachusetts 01730. 10 3. Plaintiff Cytyc Corporation is a Delaware corporation with a place of business at 250

11 Campus Drive, Marlborough, Massachusetts 01752. 12 4. Plaintiff Hologic L.P. is a limited partnership with a place of business at 250 Campus

13 Drive, Marlborough, Massachusetts 01752. 14 5. Defendant SenoRx is a Delaware corporation with a principal place of business at 11

15 Columbia, Aliso Viejo, California 92656. 16 17 6. JURISDICTION AND VENUE This Court has subject matter jurisdiction over Hologic's claims of patent infringement

18 and false advertising pursuant to 28 U.S.C. §§ 1331 and 1338(a) because the claims arise under the 19 Patent Act, 35 U.S.C. § 281 and the Lanham Act, 15 U.S.C. § 1125(a), respectively. In addition, this 20 Court has supplemental jurisdiction over the non-Federal claims for relief pursuant to 28 U.S.C. § 21 1367(a). 22 7. This Court has personal jurisdiction over SenoRx because, on information and belief,

23 SenoRx regularly and systematically transacts business in this District. 24 8. Venue is proper in this District pursuant to 28 U.S.C. §§ 1391(b), 1391(c) and 1400(b)

25 because on information and belief, SenoRx has committed, and intends to commit, acts of infringement 26 and false advertising in this District. 27 \\ 28
Amended Complaint for Patent Infringement Case No. C08 00133 RMW -1-

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 3 of 16

1 2 9.

INTRADISTRICT ASSIGNMENT This is an Intellectual Property Action within the meaning of the Court's Assignment

3 Plan, and therefore is subject to assignment on a district-wide basis pursuant to Civil Local Rule 34 2(b). 5 6 10. BACKGROUND Hologic is a leading developer, manufacturer and supplier of premium diagnostic,

7 therapeutic and medical imaging systems dedicated to serving the healthcare needs of women, and a 8 leading developer of state-of-the-art digital imaging technology for general radiography and 9 mammography applications. Hologic's business units are focused on mammography and breast 10 biopsy, direct-to-digital x-ray for general radiography applications, treatment of breast cancer, cervical 11 cancer screening gynecological surgery, osteoporosis assessment, and mini C-arm imaging for 12 orthopedic applications. Each year, more than one million women are diagnosed with breast cancer, 13 while hundreds of thousands of them fall victim to this dreaded disease. Hologic has achieved a 14 leading market position in breast cancer detection in the United States. 15 11. Through its recently-acquired Cytyc subsidiary, Hologic has, inter alia, developed and

16 marketed innovative radiation delivery systems for the treatment of cancer since 1995. One such 17 system is the MammoSite® Radiation Therapy System, which delivers targeted, therapeutically 18 effective doses of radiation directly to the breast tissue where cancer is most likely to recur. To effect 19 this delivery of radiation, the MammoSite® System provides for the placement of a radiation source 20 inside the human body, specifically within a cavity created in the breast tissue after the cancerous 21 tumor has been removed. 22 12. The MammoSite® Radiation Therapy System has been widely used by radiation

23 oncologists and breast surgeons to treat breast cancer patients who are undergoing breast conservation 24 therapy. Breast conservation therapy involves excising only the cancerous tumor in a surgical 25 procedure known as a lumpectomy and preserving the healthy breast tissue, including the nipple, the 26 skin, the fatty tissue underneath and the pectoral muscle. Because this operation does not remove the 27 entire breast (as is the case with a total mastectomy), there is a chance that some pre-cancerous and/or 28
-2Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 4 of 16

1 cancerous cells remain at the margins of excision and therefore the cancer may return. Accordingly, it 2 is recommended that patients undergo certain post-operative treatments such as chemotherapy and 3 radiation therapy to eliminate or minimize the likelihood that the cancer will recur. 4 13. The term brachytherapy refers to radiation therapy in which the radiation source is

5 placed in proximity to the tissue being treated and contrasts with the use of an external radiation 6 source, which irradiates a wider area of the body that includes the tissue to be treated. Because it 7 places the radiation source within the cavity created by the lumpectomy, in proximity to the tissue that 8 surrounded the cancerous tumor, the MammoSite® Radiation Therapy System provides a treatment 9 method referred to as breast brachytherapy. The placement of the radiation source at the lumpectomy 10 site is achieved through the use of a balloon catheter applicator. 11 14. In May 2002, Proxima Therapeutics, Inc. ("Proxima Therapeutics") obtained clearance

12 from the U.S. Food and Drug Administration ("FDA") to market the MammoSite® Radiation Therapy 13 System as a new medical device. 14 15. Proxima Therapeutics was a pioneer in breast radiation therapy and made significant

15 investments in the research, development and testing of therapeutically effective devices and methods 16 for implementing breast brachytherapy, including the MammoSite® system. 17 16. To protect those investments, Proxima Therapeutics applied for and obtained a number

18 of patents, including U.S. Patent Nos. 5,913,813, 6,413,204, and 6,482,142, which are the subject of 19 this Complaint. 20 17. In 2005, Proxima Therapeutics was acquired by Cytyc Corporation, and, in 2007,

21 Hologic, Inc. combined with Cytyc Corporation. Cytyc Corporation is the assignee and owner of U.S. 22 Patent Nos. 5,913,813, 6,413,204, and 6,482,142, which are the subject of this Complaint. 23 18. Hologic continues to invest significant time, money, and other resources to improving

24 and refining the MammoSite® Radiation Therapy System. 25 19. On information and belief, SenoRx submitted a premarket notification under Section

26 510(k) of the Food, Drug and Cosmetic Act to the FDA for its device for implementing breast 27 brachytherapy, to be marketed under the name SenoRad Multi-Lumen Balloon Source Applicator For 28
-3Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 5 of 16

1 Brachytherapy (the "SENORAD MULTI-LUMEN BALLOON"). As required by Section 510(k), 2 SenoRx had to persuade the FDA that its device is a substantial equivalent to an already approved and 3 classified medical device. 4 20. The FDA approved SenoRx's premarket notification on or about May 18, 2007, as

5 evidenced by the Section 510(k) summary (No. K071229), a true and correct copy of which is attached 6 as Exhibit D. The FDA determined that there is substantial equivalence between SenoRx's 7 SENORAD MULTI-LUMEN BALLOON and Hologic's patented MammoSite® Radiation Therapy 8 System. The notification states: "The SenoRad applicator has the following similarities to the 9 previously cleared predicate devices: same indications for use; same intended use; same intended 10 treatment site; same operating principle; same technological characteristics; equivalent dosimetric 11 characteristics; and same sterilization method. The materials of construction vary in a manner that has 12 no impact on device safety. In summary, the SenoRad Multi-Lumen Balloon Source Applicator as 13 described in this submission is substantially equivalent to the predicate devices." (See Exhibit D 14 (emphasis added).) 15 21. In accordance with Proxima's FDA clearance, the MammoSite® Instruction Manual,

16 under the heading Contraindications, cautions "Do not deliver radiation if the minimum distance from 17 the balloon surface to the skin surface is less than 5 mm; or if the distance from the balloon surface to 18 the skin surface is 5 mm over a continuous length greater than 1 cm on the surface of the skin." A true 19 and correct copy of the MammoSite Instruction Manual is attached as Exhibit E. 20 22. In accordance with Proxima's FDA clearance, the MammoSite® Instruction Manual

21 warns users that "[i]maging should verify a minimum distance of 5 mm from balloon surface to skin 22 surface; however, a minimum distance of 7 mm from balloon surface to skin surface is recommended." 23 See Exhibit E. 24 23. On information and belief, in accordance with SenoRx's FDA approval, the Instructions

25 for Use for the SenoRx device warns users "[d]o not use if a skin surface to balloon surface distance of' 26 less than 5mm will result." A true and correct copy of the Instructions For Use for the SenoRx Multi27 Lumen Balloon Source Applicator For Brachytherapy is attached as Exhibit F. 28
-4Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 6 of 16

1

24.

On information and belief, SenoRx has given the SenoRad device the commercial

2 moniker the "ConturaTM Multi-Lumen Balloon." 3 4 5 25. 26. COUNT ONE ­ INFRINGEMENT OF U.S. PATENT NO. 5,913,813 Hologic incorporates by reference its allegations in Paragraphs 1-24 above. On information and belief, and based on likely evidentiary support after a reasonable

6 opportunity for further investigation or discovery, SenoRx is presently making, using, offering for sale, 7 and/or selling a device for implementing brachytherapy (including, without limitation, the ConturaTM 8 Multi-Lumen Balloon) that infringes one or more claims of U.S. Patent No. 5,913,813 (the "`813 9 patent"), literally or under the doctrine of equivalents in violation of one or more subsections of 35 10 U.S.C. § 271. A true and correct copy of the `813 patent is attached as Exhibit A. 11 27. On information and belief, and based on likely evidentiary support after a reasonable

12 opportunity for further investigation or discovery, SenoRx is presently inducing or contributing to the 13 infringement of one or more claims of the `813 patent. 14 28. On information and belief, SenoRx's infringement of the `813 patent has been willful

15 and wanton because SenoRx has had notice of the `813 patent. 16 29. If SenoRx's infringing activities are not preliminarily and permanently enjoined,

17 Hologic will suffer irreparable harm that cannot be adequately compensated by a monetary award. 18 30. Hologic has suffered economic harm as a result of SenoRx's infringing activities in an

19 amount to be proven at trial. 20 21 22 31. 32. COUNT TWO ­ INFRINGEMENT OF U.S. PATENT NO. 6,413,204 Hologic incorporates by reference its allegations in Paragraphs 1-30 above. On information and belief, and based on likely evidentiary support after a reasonable

23 opportunity for further investigation or discovery, SenoRx is presently making, using, offering for sale, 24 selling a device for implementing brachytherapy (including, without limitation, the ConturaTM Multi25 Lumen Balloon) that infringes one or more claims of U.S. Patent No. 6,413,204 (the "`204 patent"), 26 literally or under the doctrine of equivalents in violation of one or more subsections of 35 U.S.C. § 27 271. A true and correct copy of the `204 patent is attached as Exhibit B. 28
-5Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 7 of 16

1

33.

On information and belief, and based on likely evidentiary support after a reasonable

2 opportunity for further investigation or discovery, SenoRx is presently inducing or contributing to the 3 infringement of one or more claims of the `204 patent. 4 34. On information and belief, SenoRx's infringement of the `204 patent has been willful

5 and wanton because SenoRx has had notice of the `204 patent. 6 35. If SenoRx's infringing activities are not preliminarily and permanently enjoined,

7 Hologic will suffer irreparable harm that cannot be adequately compensated by a monetary award. 8 36. Hologic has suffered economic harm as a result of SenoRx's infringing activities in an

9 amount to be proven at trial. 10 11 12 37. 38. COUNT THREE ­ INFRINGEMENT OF U.S. PATENT NO. 6,482,142 Hologic incorporates by reference its allegations in Paragraphs 1-36 above. On information and belief, and based on likely evidentiary support after a reasonable

13 opportunity for further investigation or discovery, SenoRx is presently making, using, offering for sale, 14 selling a device for implementing brachytherapy (including, without limitation, the ConturaTM Multi15 Lumen Balloon) that infringes one or more claims of U.S. Patent No. 6,482,142 (the "`142 patent"), 16 literally or under the doctrine of equivalents in violation of one or more subsections of 35 U.S.C. § 17 271. A true and correct copy of the `142 patent is attached as Exhibit C. 18 39. On information and belief, and based on likely evidentiary support after a reasonable

19 opportunity for further investigation or discovery, SenoRx is presently inducing or contributing to the 20 infringement of one or more claims of the `142 patent. 21 40. On information and belief, SenoRx's infringement of the `142 patent has been willful

22 and wanton because SenoRx has had notice of the `142 patent. 23 41. If SenoRx's infringing activities are not preliminarily and permanently enjoined,

24 Hologic will suffer irreparable harm that cannot be adequately compensated by a monetary award. 25 42. Hologic has suffered economic harm as a result of SenoRx's infringing activities in an

26 amount to be proven at trial. 27 \\ 28
-6Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 8 of 16

1 2 3 4 43. 44.

COUNT FOUR ­ FEDERAL UNFAIR COMPETITION (LANHAM ACT § 43(A); 15 U.S.C. § 1125(a)) Hologic incorporates by reference its allegations in Paragraphs 1-42 above. On information and belief, and based on likely evidentiary support after a reasonable

5 opportunity for further investigation or discovery, SenoRx has and is currently advertising its 6 ConturaTM Multi-Lumen Balloon in interstate commerce through customer presentations which 7 compare the MammoSite® Applicator and the ConturaTM Multi-Lumen Balloon. A true and correct 8 copy of one such SenoRx customer presentation is attached as Exhibit G. 9 45. On information and belief, and based on likely evidentiary support after a reasonable

10 opportunity for further investigation or discovery, SenoRx through its customer presentations cites 11 purportedly scientifically reliable data to advertise that the ConturaTM Multi-Lumen Balloon is superior 12 to the MammoSite® Applicator. SenoRx advertises, for example, that the ConturaTM Multi-Lumen 13 Balloon is superior to the MammoSite® Applicator radiation treatment of surgical margins in close 14 proximity to (at, for example, less than 5 mm from) the surface of the skin. (See Exhibit G). 15 46. On information and belief, and based on likely evidentiary support after a reasonable

16 opportunity for further investigation or discovery, such SenoRx's customer presentations are false, 17 misleading, and likely to deceive the public in that SenoRx is advertising the capabilities of the 18 ConturaTM Multi-Lumen Balloon for which SenoRx has not received FDA clearance or approval. 19 SenoRx, for example, has no brachytherapy device which is FDA cleared or approved for treatment of 20 superficial excision margins in close proximity to the surface of the skin. 21 47. On information and belief, and based on likely evidentiary support after a reasonable

22 opportunity for further investigation or discovery, SenoRx's customer presentations are false, 23 misleading, and likely to deceive the public as a result of SenoRx's failure to disclose one or more 24 material facts, as for example, the material fact that the FDA cleared labeling for both the predicate 25 MammoSite® device and the ConturaTM Multi-Lumen Balloon explicitly warns against specific use 26 with a balloon surface-to-skin surface distance of less than 5 mm. 27 \\ 28
-7Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 9 of 16

1

48.

SenoRx's false and misleading representations have confused and misled, and will

2 continue to confuse and mislead, a substantial number of persons who receive these misleading 3 representations into believing those representations, such as, for example, that the ConturaTM Multi4 Lumen Balloon is FDA cleared and/or approved for administration of radiation treatment to superficial 5 resection cavities near the surface of the skin. 6 49. On information and belief, and based on likely evidentiary support after a reasonable

7 opportunity for further investigation or discovery, SenoRx has made, used, approved, and sponsored 8 these misleading representations in promotional materials that disparage and/or discredit Hologic's 9 MammoSite® Applicator, and misrepresent the comparative superiority of SenoRx's ConturaTM Multi10 Lumen Balloon. 11 50. On information and belief, and based on likely evidentiary support after a reasonable

12 opportunity for further investigation or discovery, SenoRx relies on these misleading representations to 13 encourage customers to purchase the ConturaTM Multi-Lumen Balloon by suggesting that the 14 ConturaTM device treats a patient base (as for example, those patients with superficial excision cavities 15 close to the skin surface) for whom treatment with the MammoSite® Applicator is contraindicated. 16 51. On information and belief, and based on likely evidentiary support after a reasonable

17 opportunity for further investigation or discovery, SenoRx continues to make such misleading 18 representations with the specific intent that these representations deceive and mislead consumers and 19 potential consumers of brachytherapy products with the result that, inter alia, they will purchase 20 ConturaTM Multi-Lumen Balloons when they would otherwise have purchased MammoSite® 21 Applicators. 22 52. On information and belief, and based on likely evidentiary support after a reasonable

23 opportunity for further investigation or discovery, SenoRx's misleading statements have been placed in 24 interstate commerce, have actually deceived consumers and the public, create a likelihood that a 25 substantial segment of consumers and the public will be deceived, have substantially damaged 26 Hologic, and violate 15 U.S.C. § 1125(a). 27 \\ 28
-8Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 10 of 16

1

53.

By reason of SenoRx's acts alleged herein, Hologic has suffered, and will continue to

2 suffer, damage to its business, reputation, and good will. This harm constitutes an injury for which 3 Hologic has no adequate remedy at law. 4 54. If SenoRx's false and misleading advertisements are not preliminarily and permanently

5 enjoined, Hologic will suffer irreparable harm that cannot be adequately compensated by a monetary 6 award. 7 55. Hologic has suffered economic harm as a result of SenoRx's false and misleading

8 advertisement in an amount to be proven at trial. 9 10 11 12 56. 57. COUNT FIVE ­ STATE UNFAIR COMPETITION (CAL. BUS. & PROF. CODE SECTION 17200 et seq.) Hologic incorporates by reference its allegations in Paragraphs 1-55 above. SenoRx's unlawful, unfair, and/or fraudulent business acts and practices described

13 herein constitute unfair competition in violation of Section 17200, et seq. of the California Business 14 and Professions Code. 15 58. On information and belief, and based on likely evidentiary support after a reasonable

16 opportunity for further investigation or discovery, SenoRx has and is currently advertising its 17 ConturaTM Multi-Lumen Balloon through customer presentations which compare the MammoSite® 18 Applicator and the ConturaTM Multi-Lumen Balloon. See Exhibit G. 19 59. On information and belief, and based on likely evidentiary support after a reasonable

20 opportunity for further investigation or discovery, SenoRx through its customer presentations cites 21 purportedly scientifically reliable data to advertise that the ConturaTM Multi-Lumen Balloon is superior 22 to the MammoSite® Applicator. SenoRx advertises, for example, that the ConturaTM Multi-Lumen 23 Balloon is superior to the MammoSite® Applicator radiation treatment of surgical margins in close 24 proximity to (at, for example, less than 5 mm from) the surface of the skin. (See Exhibit G). 25 60. On information and belief, and based on likely evidentiary support after a reasonable

26 opportunity for further investigation or discovery, such SenoRx's customer presentations are false, 27 misleading, and likely to deceive the public in that SenoRx is advertising capabilities of the ConturaTM 28
-9Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 11 of 16

1 Multi-Lumen Balloon for which SenoRx has not received FDA clearance or approval. SenoRx, for 2 example, has no brachytherapy device which is FDA cleared or approved for treatment of superficial 3 excision margins in close proximity to the surface of the skin. 4 61. On information and belief, and based on likely evidentiary support after a reasonable

5 opportunity for further investigation or discovery, SenoRx's customer presentations are false, 6 misleading, and likely to deceive the public as a result of SenoRx's failure to disclose one or more 7 material facts, as for example, the material fact that the FDA cleared labeling for both the predicate 8 MammoSite® device and the ConturaTM Multi-Lumen Balloon explicitly warn against specific use 9 with a balloon surface-to-skin surface distance of less than 5 mm. 10 62. SenoRx's false and misleading representations have confused and misled, and will

11 continue to confuse and mislead a substantial number of persons who receive these misleading 12 representations into believing those representations, such as, for example, that the ConturaTM Multi13 Lumen Balloon is FDA cleared and/or approved for administration of radiation treatment to superficial 14 resection cavities near the surface of the skin. 15 63. On information and belief, and based on likely evidentiary support after a reasonable

16 opportunity for further investigation or discovery, SenoRx has made, used, approved, and sponsored 17 these misleading representations in promotional materials that disparage and/or discredit Hologic's 18 MammoSite® Applicator, and misrepresent the comparative superiority of SenoRx's ConturaTM 19 Multi-Lumen Balloon. 20 64. On information and belief, and based on likely evidentiary support after a reasonable

21 opportunity for further investigation or discovery, SenoRx relies on these misleading representations to 22 encourage customers to purchase the ConturaTM Multi-Lumen Balloon by suggesting that the 23 ConturaTM device treats a patient base (as for example, those patients with superficial excision cavities 24 close to the skin surface) for whom treatment with the MammoSite® Applicator is contraindicated. 25 65. On information and belief, and based on likely evidentiary support after a reasonable

26 opportunity for further investigation or discovery, SenoRx continues to make such misleading 27 representations with the specific intent that these representations deceive and mislead consumers and 28
- 10 Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 12 of 16

1 potential consumers of brachytherapy products with the result that they will purchase ConturaTM Multi2 Lumen Balloons when they would otherwise have purchased MammoSite® Applicators. 3 66. On information and belief, and based on likely evidentiary support after a reasonable

4 opportunity for further investigation or discovery, SenoRx's acts and practices as described herein 5 have misled and/or deceived and are likely to mislead and/or deceive members of the consuming 6 public with the result that, inter alia, they will purchase ConturaTM Multi-Lumen Balloons when they 7 would otherwise have purchased MammoSite® Applicators. 8 67. SenoRx's acts alleged herein are unlawful and fraudulent within the meaning of

9 California's Unfair Competition Law. By reason of SenoRx's acts alleged herein, Hologic has 10 suffered, and will continue to suffer, damage to its business, reputation, and good will. This harm 11 constitutes an injury for which Hologic has no adequate remedy at law. 12 68. SenoRx's acts of unfair competition have caused and will continue to cause Hologic

13 irreparable harm. If SenoRx's unfair competition is not preliminarily and permanently enjoined, 14 Hologic will suffer irreparable harm that cannot be adequately compensated by a monetary award 15 69. Hologic is entitled to a judgment enjoining and restraining SenoRx from engaging in

16 further unfair competition, and is further entitled to an award of restitution for SenoRx's unjust 17 enrichment. 18 19 20 21 70. 71. COUNT SIX ­STATE UNFAIR COMPETITION (CAL. BUS. & PROF. CODE SECTION 17500 et seq.) Hologic incorporates by reference its allegations in Paragraphs 1-69 above. On information and belief, and based on likely evidentiary support after a reasonable

22 opportunity for further investigation or discovery, SenoRx purposefully and intentionally engaged in 23 unfair, deceptive, untrue, and/or misleading advertising in violation of Section 17500 et seq. of the 24 California Business & Professions Code. 25 72. On information and belief, and based on likely evidentiary support after a reasonable

26 opportunity for further investigation or discovery, SenoRx has and is currently advertising its 27 28
- 11 Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 13 of 16

1 ConturaTM Multi-Lumen Balloon through customer presentations which compare the MammoSite® 2 Applicator and the ConturaTM Multi-Lumen Balloon. See Exhibit G. 3 73. On information and belief, and based on likely evidentiary support after a reasonable

4 opportunity for further investigation or discovery, SenoRx through its customer presentations cites 5 purportedly scientifically reliable data to advertise that the ConturaTM Multi-Lumen Balloon is superior 6 to the MammoSite® Applicator. SenoRx advertises, for example, that the ConturaTM Multi-Lumen 7 Balloon is superior to the MammoSite® Applicator radiation treatment of surgical margins in close 8 proximity to (at, for example, less than 5 mm from) the surface of the skin. (See Exhibit G). 9 74. On information and belief, and based on likely evidentiary support after a reasonable

10 opportunity for further investigation or discovery, such SenoRx's customer presentations are false, 11 misleading, and likely to deceive the public in that SenoRx is advertising capabilities of the ConturaTM 12 Multi-Lumen Balloon for which SenoRx has not received FDA clearance or approval. SenoRx, for 13 example, has no brachytherapy device which is FDA cleared or approved for treatment of superficial 14 excision margins in close proximity to the surface of the skin. 15 75. On information and belief, and based on likely evidentiary support after a reasonable

16 opportunity for further investigation or discovery, SenoRx's customer presentations are false, 17 misleading, and likely to deceive the public as a result of SenoRx's failure to disclose one or more 18 material facts, as for example, the material fact that the FDA cleared labeling for both the predicate 19 MammoSite® device and the ConturaTM Multi-Lumen Balloon explicitly warn against specific use 20 with, a balloon surface-to-skin surface distance of less than 5 mm. 21 76. SenoRx's false and misleading representations have confused and misled, and will

22 continue to confuse and mislead a substantial number of persons who receive these misleading 23 representations into believing those representations, such as, for example, that the ConturaTM Multi24 Lumen Balloon is FDA cleared and/or approved for administration of radiation treatment to superficial 25 resection cavities near the surface of the skin. 26 77. On information and belief, and based on likely evidentiary support after a reasonable

27 opportunity for further investigation or discovery, SenoRx has made, used, approved, and sponsored 28
- 12 Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 14 of 16

1 these misleading representations in promotional materials that disparage and/or discredit Hologic's 2 MammoSite® Applicator, and misrepresent SenoRx's ConturaTM Multi-Lumen Balloon. 3 78. On information and belief, and based on likely evidentiary support after a reasonable

4 opportunity for further investigation or discovery, SenoRx relies on these misleading representations to 5 encourage customers to purchase the ConturaTM Multi-Lumen Balloon by suggesting that the 6 ConturaTM device treats a patient base (as for example, those patients with superficial excision cavities 7 close to the skin surface) for whom treatment with the MammoSite® Applicator is contraindicated. 8 79. On information and belief, and based on likely evidentiary support after a reasonable

9 opportunity for further investigation or discovery, SenoRx continues to make such misleading 10 representations with the specific intent that these representations deceive and mislead consumers and 11 potential consumers of brachytherapy products with the result that they will purchase ConturaTM Multi12 Lumen Balloons when they would otherwise have purchased MammoSite® Applicators. 13 80. On information and belief, and based on likely evidentiary support after a reasonable

14 opportunity for further investigation or discovery, in making and disseminating the representations 15 described herein, SenoRx knew, or by the exercise of reasonable care should have known, that its 16 representations were untrue or misleading, and were in violation of California Business and 17 Professions Code Section 17500 et seq. 18 81. SenoRx's acts have substantially damaged Hologic's business, substantially damaged

19 consumers' interests, and unjustly enriched SenoRx, and will continue to do so unless enjoined by the 20 Court. If SenoRx's unfair competition is not preliminarily and permanently enjoined, Hologic will 21 suffer irreparable harm that cannot be adequately compensated by a monetary award 22 82. Hologic is entitled to a judgment enjoining and restraining SenoRx from engaging in

23 further wrongful conduct, and is further entitled to an award of restitution for SenoRx's unjust 24 enrichment. 25 26 83. DEMAND FOR JURY TRIAL Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure and Civil Local Rule 3-

27 6(a), Hologic hereby demands a trial by jury on all issues so triable. 28
- 13 Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 15 of 16

1 2 3

PRAYER FOR RELIEF WHEREFORE, Hologic prays that this Court grant it the following relief: (a) enter judgment against SenoRx adjudging the `204, `142, and `813 patents to be valid,

4 enforceable and infringed; 5 (b) issue a preliminary and permanent injunction against SenoRx for infringement of the `204,

6 `813, and `142 patents pursuant to 35 U.S.C. § 283; 7 (c) award Hologic an amount adequate to compensate for SenoRx's infringement of the

8 Patents-In-Suit, as provided under 35 U.S.C. § 284; 9 (d) an adjudication that SenoRx has willfully infringed the Patents-In-Suit and increasing the

10 award of damage to Hologic up to three times in view of SenoRx's willful infringement; 11 (e) enter judgment requiring that SenoRx and its officers, agents, servants, employees, owners,

12 and representatives, and all other persons, firms, or corporations in active concert or participation with 13 it, be enjoined and restrained from committing further acts of false advertising and unfair competition 14 pursuant to 15 U.S.C. § 1116(a) and California Business & Professions Code § 17203; 15 (f) award Hologic its actual damages and SenoRx's profits according to proof for SenoRx's

16 Lanham Act violations pursuant to 15 U.S.C. § 1117(a); 17 18 19 (g) award Hologic restitution and recovery of SenoRx's unjust enrichment; (h) award Hologic prejudgment interest; (i) a declaration that this is an exceptional case under 35 U.S.C. § 285 and 15 U.S.C. § 1117(a)

20 and that Hologic be awarded its attorneys' fees and costs incurred in prosecuting their claims; and 21 (j) such other relief as this Court deems proper. HOWREY LLP

22 Dated: March 7, 2008 23 24 25 26 27 28

By:

/s/ Katharine L. Altemus Katharine L. Altemus HOWREY LLP Attorneys for Plaintiffs Hologic, Inc., Cytyc Corporation, and Hologic LP

- 14 Amended Complaint for Patent Infringement Case No. C08 00133 RMW

Case 5:08-cv-00133-RMW

Document 42

Filed 03/07/2008

Page 16 of 16

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 1 of 7

Exhibit A

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 2 of 7

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 3 of 7

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 4 of 7

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 5 of 7

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 6 of 7

Case 5:08-cv-00133-RMW

Document 42-2

Filed 03/07/2008

Page 7 of 7

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 1 of 12

Exhibit B

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 2 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 3 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 4 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 5 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 6 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 7 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 8 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 9 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 10 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 11 of 12

Case 5:08-cv-00133-RMW

Document 42-3

Filed 03/07/2008

Page 12 of 12

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 1 of 11

Exhibit C

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 2 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 3 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 4 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 5 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 6 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 7 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 8 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 9 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 10 of 11

Case 5:08-cv-00133-RMW

Document 42-4

Filed 03/07/2008

Page 11 of 11

Case 5:08-cv-00133-RMW

Document 42-5

Filed 03/07/2008

Page 1 of 6

Exhibit D

Case 5:08-cv-00133-RMW

Document 42-5

Filed 03/07/2008

Page 2 of 6

Su"RXRi
5. 510(K) SUMMARY
April 20, 2007 SenoRx, Inc. 11 Columbia Aliso Viejo, CA 92656 P. 949.362.4800 F. 949.362.3200 Eben Gordon SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy Multi-lumen balloon source applicator Remote controlled radionuclide source applicator 21 CFR 892.5700 90 JAQ Adjustable Multi-Catheter Source Applicator (K062241) MammoSite Radiation Therapy System (K041929) 11/9/2006 (K062241) 8/26/2004 (K041929) The SenoRad applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 32 or 55 ml, respectively. The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Prepared date 510(k) owner

Contact person Device name Common name Classification name CFR classification Predicate device Decision date Device description

Indications for use

Summary of substantial equivalence Extensive preclinical testing was conducted to evaluate and characterize the performance of the SenoRad Multi-Lumen Balloon Source Applicator. Preclinical studies conducted included in vitro laboratory studies to demonstrate that the SenoRad applicator performed as intended under simulated use conditions. Biocompatibility testing was performed to 12

Case 5:08-cv-00133-RMW

Document 42-5

Filed 03/07/2008

Page 3 of 6

SEN6DRX
demonstrate that the materials meet ISO 10993-1 requirements. The dosimetry of the SenoRad applicator was characterized. Based on these findings, it was concluded that the SenoRad applicator could deliver an equivalent radiation dose as the current brachytherapy applicators. The SenoRad applicator has the following similarities to the previously cleared predicate devices: same indications for use; same intended use; same intended treatment site; same operating principle; same technological characteristics; equivalent dosimetric characteristics; and same sterilization method. The materials of construction vary in a manner that has no impact on device safety. In summary, the SenoRad Multi-Lumen Balloon Source Applicator as described in this submission is substantially equivalent to the predicate devices.

13

Case 5:08-cv-00133-RMW Document 42-5 Filed 03/07/2008 DEPARTMENT OF HEALTH & HUMAN SERVICES

Page 4 of 6

Food and Drug Administration
9200 Corporate Blvd.

Rockville MD 20850

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25 th Street NW BUFFALO MN 55313

MAY I 8 2007

Re: K071229 Trade/Device Name: SecoRad Multi-Lumen Ballon Source Applicator for Brachytherapy Regulation Number: 21 CFR §892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 2, 2007 Received: May 3, 2007

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

FZ'X
11% **

Case 5:08-cv-00133-RMW

Document 42-5

Filed 03/07/2008

Page 5 of 6

Page 2 Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR I1000-1 050. This letter will allow you to begin marketing your device as described in your Section 5 10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: 21 CUR 876.xxx 21 CUR 884.xxx 2! CFR 894.xxx Other (Gastroenterology/Renal/Urology, (Obstetrics/Gynecology) (Radiology) 240-276-0115 240-276-0115 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address litrp:H//ww\w.fda.eov/cdrhl/industrv/support/indexitml. Sincerely yours,

Nancy C. rgo Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure

Case 5:08-cv-00133-RMW

Document 42-5

Filed 03/07/2008

Page 6 of 6

SenoRx Inc. SenoRad Multi-Lumen Balloon Source Applicator 510(k) Submission

4.

INDICATIONS FOR USE

510(k)Number(ifknown):

1C07jt :-

Device Name:

__

SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy

__

Indications for Use:

The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Prescription Use

X

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

..........................................................................

(Division Sign-Off '.' Division of Reprod uctive, Abdominal, and Radiological Devices 510(k) Number ¾b1IO.Qq
11

Page __ of

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 1 of 43

Exhibit E

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 2 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 3 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 4 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 5 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 6 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 7 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 8 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 9 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 10 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 11 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 12 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 13 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 14 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 15 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 16 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 17 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 18 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 19 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 20 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 21 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 22 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 23 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 24 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 25 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 26 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 27 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 28 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 29 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 30 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 31 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 32 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 33 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 34 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 35 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 36 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 37 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 38 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 39 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 40 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 41 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 42 of 43

Case 5:08-cv-00133-RMW

Document 42-6

Filed 03/07/2008

Page 43 of 43

Case 5:08-cv-00133-RMW

Document 42-7

Filed 03/07/2008

Page 1 of 3

Exhibit F

Case 5:08-cv-00133-RMW

Document 42-7

Filed 03/07/2008

Page 2 of 3

Source lumen #5

Source Lumen #1

Stiffening Stylet (I)
Source Lumen #4 Source Lumen #2

Longiludinal Reference line {L}

-Applicator (A)

MULTI..LUMEN BALLOON SOVRCE ApPLICAl'OR FOR BRACHYTIIERAPY
Figure 3: SOURCE WIRE LUMEN ORIENTATION

"

Figure 1: SENOllXApPLICATOR
© 2007 by Senokx Inc. All rights reserved.

I,

This product iscoveted byone ormore ofthe following U.S. Patents: 67923,754; 6,955.641; 7,241,178. Other domestic and foreign patents pending.·' "

INSTRUC1'IONS FOR USE

" '.t

Radi~lion Sourr;e

Lumen Cap (K)

.!

(COfllmt Media Tray (0)

>~ A,~rpel(El
,

EXPLANATION OF SYMBOLS ON
~

rue PACKAGE

Catalogue Number Use by Dale
Lot Number

?" Drair'IAge
10mfSYringe

~

~
~
~

MODELS

/'../

30ff~ Syr1nge(~trr

-~~~

Jif #
.
Trocar (F)

Contentc;
Sterile (Gamma radiation) Altentiun, See Instructions for Use
Do Not Reuse

[~Lil R t

A
®

B001·45 B011-45

(/\.

r

Upper Temperature Limit
Keep away from sunlight

Figure 2: ACCESSORIES

Keep dry
lUUU93 Rev. B RCO 3776

SenolU Inc.
Aliso Viejo, California

USA
Page 5
rilgc 6
Pase 1

Case 5:08-cv-00133-RMW cavity musl be ilJ1uged before implantation toFiledapplicator wiIJ fit Document 42-7 03/07/2008 The breast insure the
appmpriatciy Do not usc if the cavity is too small orif a skin surface toballoon surface distance of'less than 5mm will result.
MULTI-LUMEN BAL~OON SOURCE APPLICATOR FOR
· To insure appropriate treatment dose distribution, the SenoRx balloon must beimaged prior to delivering each fraction ofradiation to confirm correct position, volume, skin spacing and conformance.
· If excessive resistance is encountered wht.ll aUempting to remove the SenoRx spplicator from thepatient, surgical removal isrecommended.
· Contrast media concentrations ofless than 10% arc rccomneuded 10 prevent dose allenuation,

DIRECTIONS FOR USE

Page 3 of 3
Pl.ACF.MF.NT- Refer 10Figures

I &2

BRACHYfHERAPY
Cautioll: Federal (USA) lawrestricts this device tc sale by oronthe order ofD physician.

lJESCRlPTION The SenoRx applicator cunsisis of " multi-lumen catheter attached to an infla1J1blc spherical balloon (Figure I). Lumens arc .provided for attachment to commercially available HDR (High Dose Rate) remote afterloadcr equipment for passage of the radiation SOU1tC delivery wire. Five radiation source wire lumens are provided; one centIallumen !ocaled along the long axis of the applicator and four curved lumens symmetrically onset from the cenaal lumen. A removable stiffening stylet isposil1onoo inthe centtullumen. Two proximal POlts are also provided with Lner-type connectors for balloon inflation/deflation and for application ofintracavitary vacuum.
The SenoRx Multi-Lumen Balloon Accessories provided fur introduction and deployment include: trocar with split sheath, dmi~gc catheter, three, 30 ml and one, 10 ml inflation syIingcs, #11 scalpel, contrast media tray, Iadiation lumcn caps and l:thcls

· Non-ionic contrast media is recommended for patients who am aJIf.t'gic to iodinebased agents.
PRECAUTIONS · The ScnoRx applicator must be used only by physicians trained in catheter implantation, radiation treatment planning und delivery,
· Metal vascular and marking clips should not be used during the lumpeclomy procedure to prevent potential nbmsion orpuncture ofthe ScnoRxnt balloon. Care should also be taken to directsnture knotj and fAil~ away from the cavity and whenever possible position tissue between the potential balloon surface and the rails.
· Store fhe ~cnoRx applicator atroom temperatare (20 to25°C).

I. Usc ultrasound tuidentify thelumpectnmy cavity. 2. Open the SenoRx applicator sterile package and remove the Applicator (A) and one 30 1111 Syringe (B). Remove the Inflation Port Lucr Cap (C) nnd injecl 58 ml of .sterile saline inlo the Applicator and inspect for leaks and spherical symmetry. Discard Applicator if defective. Wilhdmw saline Innuballoon, l. Prepare a maximum 10% contrast mcdialsterile saline solution 4t the Tray (D) provided. 4. Determine the desired point on the breast surface for the insertion of the SenoRx applicator. Inject appropriate ane~thetic to the skin and pathway to the lumpectomy cavity. Make a skin incision with the scalpel at the insertion point of sufficient length lu fully iusen the Trocar (F) tip. Dilate the skin incision, if desired. Advance the Trocar with Split Sheath (G) into the cavity. Remove theTrocar, 5. Attach a 30 mI syringe to the Dminuge CU~lel~r (H) and drain any fluids within the cavity by il1serting the Drainage Catheter through the Split Sheath and 5uctioning. Remove the Drainage Catheter. 6. Insert the Applicator through the Split Sheath inlo the cavity. Remove the Sheath. 7. Remove the ~liITClJing Stylet (I) from the Central Source Lumen (1). Attach a red rndiallun suurce lumen Cap (K). 8. Using the syringes provided, inflate the Applicator balloon with the contrast media solution to the desired fill volume.

(Figura 2).
.:~. __:..~ucle1ron

Desired balloon diameter

Approximate baDoon fill volume
33ml
-.

1J1eSmoRx applicator model BOO1-45 is recommended for usc with VuriSol1rce and HDR. afterloader equipment while .model B011-45 is recommended for use with GamwaMed aftedoaders.
.1

· Care must betaken when hAndling and manipulating the Sel10Rx balloon toprevent damage and foreign material contnmination oftbe balloon surface.

4cm
Scm

5Sml

~amin~: lb~ sa~e~ an~ eflecuvcaess of ~ SenoRx Applicator asa replacement for;. !
whole breast IfTJdl3tron an the treatment ofbreast cancer has not been established.
.1

A :i(;a1~1 should beused toinci,s~ the skin prior to inserting the trocar tip.
r
~

io. ~

Do not inject fluids into the VacuuinPort.
. .I

INDICATIONS FOR USE I The SenoRx Multi-Lumen Balloon is intended to provide brachythernpy when the
cbooscs to deliver intracavilary radiation to the surgical margins following lumpcctQItly for breast cancer.
ph~ician

· Replace Luer caps WId rndiation lumen caps after use. · Only clinical pcrsonacl trained inthe operation of HDR afterloaders should deliver radiation using the SenoRx applicator.
Verify lhat the appropriate aftcrloadcr connectors nre available and function with the SenoRx applicator prior tolItatmenl

9. Replace the LucrCap on tothe Inflation Purt 10. Use ultrasound to confirm appropriate placement, volume and cavity confonnance. Fluid and air surrounding the Applicator balloon may be aspirntcd with n 30 m1 Syringe attached to the Vacuum Port (LJ. The volume of the balloon may be adjusted through the lnJIation Port (C). Replace Luer Caps when finished. IJ. Apply a surgical dres~illg to the exit site with the catheter positioned lu minimize hcnding.. 12. Record the final balloon fill volume on the Labels provided and auacb to the
patient's chart.
RADIATION DELIVERY - Refer to Figure 3

CONTRAINDICATIONS
· The applicalor isnot intended for use in cavities that arc too smull, too large and/or of shapes unable toconform toanapproximaldy spherical. 4 to5 em diameter ScnoRx

· Be sure that the SenoR! applicator i~ asslrdighl as possible and free ofsharp bends and kinks prior to connecting to the HDR aflerloader,
· Inspect package before use. Discard if seal iscompromised orpackagillg isdamaged.

1. CT imnging should he used inconjunction with commercially available trcatml,l1l planning software to detcnninc the appropriale source lutncn.~, source dwell

balloon.
· The applicator isnot intended for use inpatients with unusual anatomy including a highly curved rib structure and/or unequal amounts oftissue surrounding the cavity that may cause the SenoRx balloon tobeasymmetrical,
WARNINGS
· Use caution when positioning the trocar tip near the chest wall orskin margin to avoid

COMPLICATIONS
Complications that may beassociated with the use ofthe SenoRx applicator are the same as those associated with the use of similar devices. These may include: erythema, catheter site drainage, breast pain, ecchy 1Il0S is, breast fibrosis, telangiectasia, breast induration, breast serorna, breast edema, dry desquamation, dry skin, skin discoloration, parasthesia, axilllary pain, fatigue, pnnitis, breast retraction, nausea, skin irritation, moist desquamation, hematoma, rash, asymptomatic fat necrosis, breast infection, breast blister and lymphedema.

2.
3.

uninlended tissue damage.

· Do not fill the Applicator willi more Ulan 58 1111 offluid as overfilling may result in balloon rupture untl/or device failure.

positions and dwell times for optimized radiation dcJivci)' ofa pJOcnbed dose to the targeted treatment volume. Verify correcl balloon position, volume. skin spacing and conformance using imaging prior todelivery ofeach fraction ofradiation. The ScnoRx applicator rcd-enpped, radiation source wire lumens are numbered' 1', '2', '3\ '4' and '5' and positioned as shown in Figure 3. Lumen number I' corresponds tothe offset lumen closest and parallel tothe longiluoinal radiopaque line (M) uklllg the outside ofthe catheter. Lumen number 15' corresponds to the central lumen. Remove the red caps and use (;ulIumm.:ially available connectors to attach the source lumens 10 the aftcrloadcr. After each treatment replace the red caps.
I

, The Appliculor must be pre-tested before implanLaliUIL Do not usc the balloon if it is
not approximately spherical and/or any leakage is detected.
Page 2

How SUPPLll£D
The ScnoRx applicator and accessories are provided sterile and are intended for single patient use only. Page 3

REMOVAL

Remove the SenoRx. applicator by first attaching a syringe (0 the Inflation Port and deflating the balloon and then simuhaneously rotating and pulling (unscrewing) the catheter from the cavity.
Page 4

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 1 of 18

Exhibit G

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 2 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 3 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 4 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 5 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 6 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 7 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 8 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 9 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 10 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 11 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 12 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 13 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 14 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 15 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 16 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 17 of 18

Case 5:08-cv-00133-RMW

Document 42-8

Filed 03/07/2008

Page 18 of 18