Waltham, Mass.-based TEI Biosciences won the FDA’s green light to launch a U.S. clinical trial evaluating its breast reconstruction device in women who have undergone a mastectomy.
TEI’s SurgiMend PRS device is designed to reduce the risk of capsular contracture, a complication from breast reconstruction surgery in which the skin around the implant contracts, potentially resulting in pain and poor cosmetic outcomes. TEI’s Acellular Dermal Matrix may help prevent the onset and reduce the severity of capsular contracture, according to the company.
The trial will attempt to prove that SurgiMend PRS can reduce the rate of moderate and severe capsular contracture by 50% when used during a 2-stage breast reconstruction procedure that 1st expands chest tissue and then inserts implants.
"We have been working with the FDA for over 2 years and we’re very pleased to receive approval to begin enrolling patients in this 1st of several pivotal IDE studies, which we believe will help advance this important aspect of women’s health, " Dr. Yiannis Monovoukas, CEO, said in a press release.
TEI currently sells SurgiMend PRS for hernia repair, plastic & reconstructive surgery, soft tissue reconstruction and muscle flap reinforcement. The company also makes the Durepair for cranial dura repair, marketed by Medtronic (NYSE:MDT), the Xenform for pelvic floor reconstruction, marketed by Boston Scientific (NYSE:BSX), and the TissueMed for tendon augmentation, marketed by Stryker (NYSE:SYK).