Inamed Announces FDA Approval of Expanded Clinical Study for Style 410 Silicone-Filled Breast Implant; Completed Study Expected to be Basis for PMA
Application
SANTA BARBARA, Calif.--(BUSINESS WIRE)--March 5, 2001--Inamed Corp. (Nasdaq:
IMDC) today announced that FDA has approved the expansion of McGhan Medical's IDE Clinical Study of the Style 410 Silicone-Filled Breast Implant to a full-scale pivotal study.
McGhan Medical is a subsidiary of Inamed Corp.
The expanded study will involve 940 patients at 100 institutions and addresses all of the clinical requirements of FDA's Breast Implant Guidances.
The original feasibility study, which was approved on Sept. 8, 2000, was limited to 25 patients. The new study will include separate patient cohorts for augmentation, reconstruction and revision of existing implants.
Upon completion, the pivotal study will serve as the basis for a pre-market application (PMA) to market the Style 410 for augmentation, reconstruction and revision indications in the United States. The Style 410 has been marketed outside the United States since 1994 by McGhan Ltd., also an Inamed subsidiary, and is currently the predominant breast implant sold by McGhan Ltd.
The Style 410 is a shaped implant with a textured surface and uses Cohesil(R) silicone gel fill. It is available in a family of profiles of specific proportions of width, height and anterior projection. Each profile is available in a full range of sizes designed to accommodate a wide range of patient anatomies and personal preferences.
The Style 410 represents a significant increase in shaped implant options in the McGhan Medical product line. McGhan currently distributes only the Style 153, a shaped implant with a standard silicone fill available in a single profile and a limited range of sizes. The Style 153 is only available through McGhan Medical's Adjunct and Core Clinical Studies.
The Cohesil(R) gel fill used in the Style 410 improves the ability to design and manufacture shaped breast implants. The Cohesil(R) silicone gel fill is significantly more cohesive than the gel used in the standard silicone-filled breast implants in the McGhan Medical Adjunct and Core Clinical Studies.
The cohesive nature of the Cohesil(R) gel fill serves to maintain implant shape with a single lumen construction. In contrast, the standard gel fill used in the Style 153 requires a more complicated, double lumen construction to maintain implant shape. The potential for reduced silicone migration of Cohesil(R) gel in the event of implant rupture remains to be established.
About Inamed Corp.
Inamed is a global surgical and medical device company engaged in the development, manufacturing and marketing of products for the plastic and reconstructive surgery, aesthetic medicine and obesity markets. Inamed sells a variety of lifestyle products used to make people look younger and more attractive, including breast implants for cosmetic augmentation and collagen-based facial implants to correct facial wrinkles and to improve lip definition.
Inamed also sells products that address women's health issues, including breast implants for reconstructive surgery following a mastectomy and devices that treat severe obesity and urinary incontinence.
CONTACT: Inamed Corp.
Michael Doty, 212/273-3430 (Investor)
or
Citigate Sard Verbinnen
Anna Cordasco/Denise DesChenes, 212/687-8080 (Media)
KEYWORD: CALIFORNIA
BW0077 MAR 05,2001
4:00 PACIFIC
7:00 EASTERN
