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Benvenue Medical receives FDA clearance for new fusion device

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Benvenue Medical announced today that the company’s Luna 360 Interbody Fusion System has received 510(k) clearance from the U.S. Food and Drug Administration for spinal fusion treatment of symptomatic degenerative disc disease.

The minimally invasive lumbar interbody fusion device uses Benvenue Medical’s proprietary implant technology, providing spine surgeons with a small delivery cannula for posterior access with an implant that expands to a larger footprint. After removal of the cannula, bone graft is placed in the middle of the implant, and the implant is locked in place with a locking wire, according to a company press release.

The Luna 360 is made from PEEK-Optima, a biocompatible polymer also used in the Kiva VCF Treatment System. The implant’s minimally invasive design is intended to help reduce tissue retraction.

According to the release, the system is intended for patients who have had at least 6 months of nonoperative treatment. Additionally, the implant is to be used with supplemental fixation.

Reference: www.benvenuemedical.com.