FDA Clears Novel Minimal Access Distal Radius Fracture System

In short

Conventus Orthopaedics‚ has received FDA 510(k) clearance to market its Conventus DRS™ Implant for the treatment of distal radius fractures within the United States. The Conventus DRS Implant is designed to provide a less invasive means for orthopaedic surgeons to treat patients with distal radius fractures, returning them to normal daily activities sooner and with less pain.

Background

In case you were wondering, Conventus Orthopaedics takes its name from the Latin word for coming together or union, appropriate enough for a trauma business. The company focuses its energy on revolutionising treatment for peri-articular fractures and has come up with a unique, self-expanding implant that stabilises the fracture fragments from within the bone. The surgical procedure requires only a two to three centimetre incision on the forearm and a few tiny incisions at the wrist.

The company says this technique reduces surgical trauma by as much as 80 percent compared to traditional plate and screw fixation techniques. Additionally it preserves soft tissues around the fracture to minimise stiffness, swelling, and pain.

The DRS implant represents the first minimally-invasive, fragment-specific system that effectively addresses a wide range of fracture types with fixation stability equivalent to traditional plates and screws.

 Physician comments

During a recent American Hand Society (ASSH) workshop, surgeons presented results from a 60 patient multi-centre European clinical study. Michael Strassmair, MD, served as the principal investigator for that study and commented, “In Starnberg, we have used the Conventus DRS implant successfully in over 30 patients. We have been able to successfully treat a broad range of distal radius fractures using the system and see significant advantages in comparison to volar plating. Early pain relief for patients has translated into the early mobility necessary for rapid recovery.”

Randip Bindra, MD, a Fellowship Program Director of Hand Surgery in Chicago, commented, “The introduction of the Conventus DRS Implant will allow orthopedic surgeons to treat a broad range of distal radius fractures in a much less invasive manner without sacrificing stability of the repair. We are very eager to begin using this novel technology to improve patient care for this commonly occurring traumatic injury.”

Company comments

“Conventus is very pleased to bring this innovative technology to the U.S. expanding the possibilities for quality patient care. The results from our European clinical study indicate that this will be a very successful technology for distal radius fractures in the U.S. and around the globe. We are enthusiastic about receiving our FDA 510(k) clearance. This supports Conventus’ plans for both U.S. and OUS business expansion,” added Paul Hindrichs, CEO of Conventus Orthopaedics.

Source: Conventus Orthopaedics, Business Wire