Active Implants granted IDE approval for meniscus implant

Active Implants recently announced it has received IDE approval for a clinical trial of its NUsurface Meniscus Implant.

The prospective, randomized, multicenter study will compare the effectiveness of the company’s implant with the current standard for patients with persistent knee pain following meniscectomy surgery. The device, focused on aiding patients with knee osteoarthritis, can be implanted using an arthroscopic approach and a mini-open procedure.

“Clinical studies outside the USA have shown that the NUsurface Meniscus Implant results in significant pain relief and restoration of function compared to currently available treatments,” Henry Klyce, chairman and CEO of Active Implants, said in a company press release. “Receiving an IDE is a significant milestone toward obtaining pre-market approval in the U.S.”

“I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement,” Peter Verdonk, MD, PhD, an investigator in a different multicenter trial from the Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, said in the release.

Thus far, the device has received CE approval for commercialization in the European Union and Israel.