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Home/Large Joints and Extremities/FDA Clears Conventus DRS Implant
Large Joints and Extremities

FDA Clears Conventus DRS Implant

February 6, 2013 1 min read Premium comments

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FDA Clears Conventus DRS Implant
Courtesy of Conventus Orthopaedics, Inc.
Secondary

Conventus Orthopaedics, Inc. a privately held company focusing on treatment for peri-articular fractures, has received 510(k) clearance from the FDA to market its Conventus DRS implant within the United States. The implant is designed to provide a less invasive means to treat patients with distal radius fractures—hopefully returning them to daily activities sooner and with less pain.

According to the Conventus literature, the 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% compared to traditional plate and screw fixation techniques. The technique preserves soft tissues around the fracture to minimize stiffness, swelling, and pain. Company officials say 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.

Reporting on a 60 patient multi-center European clinical study, Michael Strassmair, M.D., the principal investigator, said, “In Stamberg we 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.”

The company takes 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. It is located in Minneapolis, Minnesota.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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