Establishment Labs Receives IDE Approval from U.S. FDA to Initiate Clinical Trials

[FactMan]

 

 

NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc., a global medical device company focused on breast aesthetics and reconstruction technologies with a strong emphasis on product development and innovation, announced today that it has received an investigation device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial for its Motiva Implants, the lead product in its portfolio of innovative aesthetic technologies.

The IDE approval enables Establishment Labs to move forward with a single arm, multi-center study investigating female patients receiving primary breast augmentation, primary breast reconstruction, or revision surgery.

“I’m delighted to have the opportunity to participate in a study that has the potential to bring new insights to the breast aesthetic and reconstruction industry. Motiva Implants are innovative and differentiated, and we hope that these innovations will show significantly improved patient outcomes,†said Dr. Caroline Glicksman, a board certified plastic surgeon and Medical Director of the Motiva Implants clinical trial.

Motiva Implants are designed with a TrueMonobloc® shell that results in a strong and durable breast implant with exceptional elasticity for ease of insertion and small incisions. The cell-friendly surface technology behind Motiva Implants has demonstrated low complication rates in recent publications. For better aesthetic outcomes, the soft, form-stable filling gel allows for optimal shape retention, a natural look, and comfortable feel for women. Establishment Labs maintains strict manufacturing practices and adherence to both United States and European standards.

Basically a green light for them to start trying with better boob implants

 

Source

 

http://establishmentlabs.com/