Mentor Worldwide LLC, a Johnson & Johnson Medical Devices Company, has introduced a tissue expander with a smooth surface to its line of CPX4 Breast Tissue Expanders in the United States.
The new CPX4 device has a smooth surface designed to help ease insertion and removal1, and now includes additional suture tabs2to enhance fixation while reducing the risk of rotation for subcutaneous and submuscular breast reconstruction.
“I am looking forward to using the CPX4 Smooth expander in prepectoral and submuscular breast reconstruction,” said Mark Migliori, MD, a board certified plastic surgeon in Edina, Minnesota. “I believe it will offer ease of use during placement and removal with the added protection of the proprietary BufferZone, along with providing a natural breast shape and a soft comfortable expander for the patient.”
Mentor also says it has plans to expand its portfolio of breast implants to broaden access for women who currently have few sizing options. In 2015, the company received FDA Investigational Device Exemption (IDE) approval for its ATHENA clinical trial, which is evaluating the safety and effectiveness of larger sizes of Mentor MemoryGelBreast Implants for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI, or greater amounts of removed mastectomy tissue.
The ATHENA study is the largest pre-approval, manufacturer-sponsored breast implant clinical trial registered with the FDA to date, in terms of number of reconstruction patients enrolled. As of September 2018, more than 330 women across 32 investigational sites have been enrolled. Mentor anticipates completing enrollment of the full 400 patients by the end of 2018.Next Story