Artelon receives FDA 510(k) clearance of ligament reinforcement system
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Key takeaways:
- Artelon Inc. received FDA 510(k) clearance of its FlexBand, FlexPatch and FlexBand Plus.
- The products are indicated for patients undergoing ligament reinforcement surgery.
Artelon Inc. has announced FDA 510(k) clearance of its FlexBand, FlexPatch and FlexBand Plus for reinforcement during ligament repair surgery, according to a press release.
The FDA clearance expands the indications for the FlexBand, FlexPatch and FlexBand Plus to include medial, lateral and ulnar collateral ligaments, spring ligaments, deltoid ligaments and extra-articular ligaments, according to the release.
“This new regulatory clearance establishes a unique and specific framework of U.S. marketing claims for reinforcement of ligaments,” Aaron Smith, CEO of Artelon, said in the release. “Recent innovation in our space has been mostly focused on fixation of ligaments to bone, but little has been done to address failure of the ligament tissues themselves, which are often diseased and may lead to poor surgical outcomes. We are currently a leader in the large and growing U.S. ankle instability market. This new set of claims permits us to take on a multitude of unmet clinical challenges in the ankle and other joints and dramatically expand our addressable market,” Smith said.
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