Conventus Orthopaedics Completes Enrollment in Multi-Center European Clinical Study of Novel Fracture Implant
MINNEAPOLIS--(BUSINESS WIRE)--Aug 1, 2012--Conventus Orthopaedics‚ a privately held fracture fixation company focused on revolutionizing treatment for peri-articular fractures, announced that it has completed enrollment of an international multi-center clinical study of the Conventus DRS™ Implant with 60 patients from six institutions throughout Germany and Switzerland. The Conventus DRS Implant is designed to provide a less invasive means for orthopaedic surgeons to treat patients with this traumatic injury, returning them to normal daily activities sooner and with less pain.
The study measured the effectiveness of the Conventus DRS Implant in treating a variety of distal radius fractures, one of the most commonly fractured bones of the body. Clinical outcomes for this study demonstrated early and consistent healing with expected return to function and low complication rates. Independently reviewed radiographic evidence showed that all available patients demonstrated healing across the fracture site as early as six weeks, and Disabilities of the Arm Shoulder and Hand (DASH) scores showed significant functional improvement at 12 weeks.
“The Conventus study provides a large set of radiographic and functional data across a wide variety of surgical patients. We expect to use the insights gained from this study to further understand how this new technology can help patients return rapidly to normal function with fewer complications,” said Michael Strassmair, M.D., an orthopaedic surgeon at the Klinikum Starnberg who performed the first implant as an investigator in the study.
The Conventus DRS technology provides clinicians with a unique self-expanding implant that stabilizes the fractured bone fragments from within the bone. The surgical procedure requires only a two to three centimeter incision on the forearm and a few small incisions distally. The technique reduces surgical trauma by as much as 70 percent compared to traditional plate and screws fixation, and 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 patterns with fixation strength as good as or better than traditional plates and screws.
“Our clinical study validates proof of concept and demonstrates the potential of our technology. We are now embarking on a European postmarket clinical investigation to further demonstrate the potential of our technology in treating peri-articular fractures, and preparing for broader regulatory approval and commercial launch,” added Paul Hindrichs, CEO of Conventus Orthopaedics.
The Conventus DRS™ is pending 510(k) clearance by FDA and is not yet cleared for commercial distribution in the U.S. About Conventus Orthopaedics Conventus Orthopaedics, Inc. was founded in 2008 by a team of medical device professionals and physicians with the sole purpose of improving patient care by creating less invasive solutions to a broad range of challenging end-bone fractures. Taking its name from the Latin word for coming together or union, the company is dedicated to working together with orthopedic surgeons to improve the healing process for patients that suffer fractures in proximity to vital joint structures.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: HEALTH CLINICAL TRIALS MEDICAL DEVICES RESEARCH SCIENCE GENERAL HEALTH SOURCE: Conventus Orthopaedics, Inc. Copyright Business Wire 2012 PUB: 08/01/2012 12:59 PM/DISC: 08/01/2012 12:59 PM http://www.businesswire.com/news/home/20120801006270/