Mentor Receives FDA IDE Approval for its ATHENA Clinical Trial

With this approval, U.S. clinical investigators are able to begin testing the safety and efficacy of MENTOR® MemoryGel® Breast Implant in larger sizes

Feb 16, 2016, 08:00 ET from Mentor Worldwide LLC

IRVINE, Calif., Feb. 16, 2016 /PRNewswire/ -- Mentor Worldwide LLC, a global leader in breast reconstruction, today announced that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its ATHENA clinical trial. The trial is designed to demonstrate the safety and effectiveness of new sizes of MENTOR® MemoryGel® Breast Implants for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue.

"There is a clinical need for breast implants larger than those currently available in the United States," said Dr. David Caplin, Board-certified Plastic Surgeon and President of Parkcrest Plastic Surgery Associates in St. Louis, Missouri.[1] "The size options for breast implants today are not adequate, especially when performing reconstructive surgery on large-breasted women diagnosed with breast cancer."  The largest implants currently available in the U.S. are 800cc.

Mentor expects to begin enrolling primary and revisionary breast reconstruction patients in the ATHENA clinical trial by April 2016. The ATHENA trial plans to enroll 600 patients at up to 35 sites nationwide and test implants manufactured using the same shell and gel as Mentor MemoryGel® Breast Implants. They will  range in size from 750cc to 1445cc.

"Obtaining IDE approval for the ATHENA clinical trial and the investigation of these larger implant sizes as part of the Mentor® MemoryGel® Breast Implant product family underscore our commitment to reconstruction," said Luis Davila, Vice President, Research & Development, Mentor Worldwide LLC. "We hope this study will contribute to a broader patient access to reconstruction surgery and address a long-standing patient need."  

As the leader in breast reconstruction, Mentor has launched multiple reconstruction solutions over the past 18 months, including new MemoryShape® Breast Implant styles and the ARTOURA™ Breast Tissue Expander. Mentor Breast Implants are backed by substantial clinical data demonstrating safety and effectiveness in primary augmentation, reconstruction and revision patients.[2]

About Mentor Worldwide LLC

Founded in 1969, Mentor Worldwide LLC is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation.  Mentor joined the Johnson & Johnson Family of Companies in 2009 and is the only manufacturer whose silicone breast implants are made in the U.S.A.. For more information about Mentor visit: www.mentorwwllc.com or either of Mentor's two additional websites: www.LoveYourLook.com or www.YourBreastOptions.com.       

[1] Dr. Caplin is a paid consultant to Mentor Worldwide LLC.

[2] Mentor Core and Continued Access studies for round and shaped breast implants.

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SOURCE Mentor Worldwide LLC



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