Bioventus (NSDQ:BVS) announced today that it received FDA 510(k) clearance for its neXus BoneScalpel Access handpiece.
Durham, North Carolina-based Bioventus said in a news release that the neXus ultrasonic surgical aspirator system — a next-generation integrated ultrasonic surgical platform driven by a proprietary digital algorithm — powers the BoneScalpel Access device.
The neXus system combines all features of soft and hard tissue removal in a single, fully integrated offering, Bioventus said. Its indications under FDA 510(k) clearance include use in the fragmentation and aspiration of soft and hard tissue in neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecology and more.
Bioventus plans to launch BoneScalpel Access — a product the company picked up through its recent acquisition of Misonix — in 2022. The neXus ultrasonic surgical aspirator system has already been commercialized in the U.S., Canada, Europe and Australia.
“The BoneScalpel Access handpiece provides surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization,” Bioventus SVP of Quality & Regulatory Affairs Sharon Klugewicz said in the release. “BoneScalpel Access allows for en-bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user.
“The BoneScalpel Access handpiece represents the latest innovation in our best-in-class ultrasonic surgical platform, and we anticipate that surgeons will want to leverage our portfolio of bone graft substitutes to achieve bone fusion for their patients.”