Conventus Orthopaedics Announces U.S. FDA Clearance for Less Invasive Fracture Treatment Technology
MINNEAPOLIS--(BUSINESS WIRE)--Jan 28, 2013--Conventus Orthopaedics‚ a privately held company focused on revolutionizing treatment for peri-articular fractures, announced that it has received 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.
Conventus recently demonstrated its novel technology at the American Society for Surgery of the Hand (ASSH) meeting in Chicago and received overwhelming interest from the U.S. orthopedic community. During an ASSH workshop, surgeons presented results from a 60 patient multi-center European clinical study demonstrating excellent results. 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.” Conventus DRS technology provides clinicians with a unique, self-expanding implant that stabilizes the fracture fragments from within the bone. The surgical procedure requires only a two to three centimeter incision on the forearm and a few tiny incisions at the wrist. The technique reduces surgical trauma by as much as 80 percent compared to traditional plate and screw fixation techniques. The Conventus technique preserves soft tissues around the fracture to minimize stiffness, swelling, and pain. It 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.
“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.
About Conventus Orthopaedics Taking its name from the Latin word for coming together or union, Conventus Orthopaedics is focused on creating less invasive solutions to fractures in and around joints. The company is dedicated to working with surgeons to improve healing and enable their patients’ return to normal activity.CONTACT: Conventus Orthopaedics, Inc.
Paul Hindrichs President and CEO PHindrichs@conventusortho.com or Padilla Speer Beardsley: Dave Folkens, 612-455-1741 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA MINNESOTA INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES FDA SOURCE: Conventus Orthopaedics, Inc. Copyright Business Wire 2013 PUB: 01/28/2013 09:00 AM/DISC: 01/28/2013 09:01 AM http://www.businesswire.com/news/home/20130128005345/