Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA investigational device exemption approval for its Athena clinical trial testing its Mentor MemoryGel breast implants.
The Mentor MemoryGel beast implants are designed for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue, the company said.
“There is a clinical need for breast implants larger than those currently available in the United States. The size options for breast implants today are not adequate, especially when performing reconstructive surgery on large-breasted women diagnosed with breast cancer,” Dr. David Caplin of St. Louis, Mo.’s Parkcrest Plastic Surgery Associates said in prepared remarks.
The company said it is slated to enroll 600 primary and revisionary breast reconstruction patients in its Athena clinical trial by April this year at 35 sites across the U.S. The trial will test sizes larger than 800cc, the largest currently available in the U.S., ranging between 750cc and 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. We hope this study will contribute to a broader patient access to reconstruction surgery and address a long-standing patient need,” R&D veep Luis Davila said in a press release.
