PALM BEACH GARDENS, Fla., Might 12, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical know-how firm centered on accelerating the adoption of minimally invasive surgical procedure (MIS) as the usual of care in backbone, at present introduced that it has obtained 510(okay) clearance from the U.S. Food and Drug Administration (FDA) for its FlareHawk TiHawk™11 Interbody Fusion System. TiHawk11 is the most recent addition to Accelus’s flagship FlareHawk® portfolio of spinal fusion cages, which at the moment are accessible in a bigger footprint with titanium on the bony interface.
TiHawk11 options an 11mm-wide insertion profile and expands to 17mm in width and 14mm in top, offering 70% extra footprint than a 10mm-wide interbody gadget of equivalent size. This bigger interbody footprint is designed to extend stability and supply the flexibility to post-pack bone graft after increasing to extend graft quantity.
“TiHawk11 is much more of an awesome factor. These interbody cages characteristic multi-planar enlargement, adaptive geometry, and open structure designed to facilitate safer insertion and deployment–distinctive properties that may decrease subsidence and maximize fusion,” mentioned Dr. Peter Derman, a minimally invasive and endoscopic backbone surgeon at Texas Again Institute who was concerned within the design of TiHawk11. “By increasing on their household of TiHawk choices to incorporate this even bigger footprint, Accelus has supplied surgeons with a complete set of units for any transforaminal or posterior lumbar interbody fusion process. I’m so excited to get this implant in my fingers!”
TiHawk11 cages are manufactured utilizing an progressive titanium and PEEK bonding course of that deposits a uniform, 0.5-micron-thick layer of titanium on the bonding interface. This offers sturdy adhesion between the PEEK and titanium with out the lack of fluoroscopic visualization usually related to titanium implants. The mixture of PEEK and titanium might also allow a modulus extra much like bone.
“I’m extremely happy with the advances in our new TiHawk11 system, which mixes the small insertion profile of FlareHawk with the biggest footprint we’ve provided surgeons so far,” mentioned Chris Walsh, CEO and Co-Founding father of Accelus. “These options, together with the favorable traits of PEEK with titanium, allows TiHawk11 to actually embody our mission of serving to speed up the transfer to minimally invasive surgical procedure and supply one other useful gizmo for backbone surgeons to have accessible for his or her sufferers.”
Accelus is dedicated to accelerating minimally invasive backbone surgical procedure by means of its enabling know-how with broad accessibility to beforehand underserved markets. Established in 2021 by means of the mixture of Integrity Implants and Fusion Robotics, the corporate is concentrated on offering its proprietary Adaptive Geometry™ know-how with pragmatic and economical navigation and robotic options with broad scientific use in backbone surgical procedure. Be taught extra at www.accelusinc.com.
Media Contact: Brandy Craig
Investor Contact: Brian Johnston
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