Anika Therapeutics receives FDA 510(k) clearance of rotator cuff augmentation system
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Key takeaways:
- Anika Therapeutics Inc. has announced FDA 510(k) clearance of its Integrity implant.
- The implant features a regenerative hyaluronic acid-based patch system for rotator cuff augmentation.
Anika Therapeutics Inc. has announced FDA 510(k) clearance of its Integrity implant, a regenerative hyaluronic acid-based patch system for rotator cuff augmentation, according to a company press release.
The Integrity system uses collagen patches with hyaluronic acid (HA) to promote cell infiltration, tissue remodeling and tendon thickening for patients undergoing rotator cuff repair, according to the release.
“The clearance of Integrity is a key milestone in the continued build-out of Anika’s proprietary HA-based regenerative portfolio and underscores our commitment to helping surgeons improve outcomes in rotator cuff repair procedures through biologic healing,” Cheryl R. Blanchard, PhD, president and CEO of Anika Therapeutics, said in the release. “The HA-based patch, together with the instrumentation and fixation, provides a seamless, efficient and elegant rotator cuff repair solution. This clearance opens significant opportunities in the shoulder, and we see future expansion for this innovative technology in other anatomies,” she added.
The company has plans for a limited U.S. market release of the Integrity in the first quarter of 2024.
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