FDAnews Device Daily Bulletin

Smith & Nephew Launches Advanced Biocomposite Implant

Nov. 13, 2013

Smith & Nephew announced the U.S. launch of its Healicoil Regenesorb suture anchor at the Arthroscopy Association of North America Fall Course in Las Vegas. The implant, used in repairs of the shoulder rotator cuff, consists of open-architecture that allows blood and bone marrow from the surrounding bone to enter and promote bone healing.

The FDA cleared Healicoil Regenesorb via the 510(k) process last April.

While most implants of this type contain beta tricalcium phosphate, the Smith & Nephew product goes a step further in adding calcium sulfate to better promote bone healing, the company said.

In preclinical tests, Healicoil Regenesorb allowed for new bone to fill spaces between threads and in the central channel within 12 weeks after implantation. Testing also showed that Smith & Nephew’s implant provided better engagement than others of its kind.

Biomechanical testing was performed in five pounds per cubic feet bone block, a substance whose density mirrors “the worst-case, poorest-quality decorticated humeral bone,” the company said.

The company estimates that more than 1 million shoulder rotator cuff surgeries are performed globally each year. — Lena Freund

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