SpineFrontier Receives FDA Approval for A-CIFT SoloFuse HA Standalone System
SpineFrontier has received FDA approval for A-CIFT SoloFuse HA, its next wave of fusion technology, designed and developed with intention by their team of engineers. As the primary company to receive FDA clearance on HA PEEK in the U.S. and creator of the first human spinal implant with HA, SpineFrontier produced the A-CIFT SoloFuse HA standalone system to leverage the familiarity of existing techniques, while providing an alternative to traditional plating for one level procedures - with the added hydroxyapetite (HA) biologic component.
A-CIFT SoloFuse HA integrates PEEK-OPTIMA impregnated with HA into its design. The revolutionary biomaterial PEEK-OPTIMA HA Enhanced, developed by Invibio, is fully integrated with hydroxyapatite to foster greater bone formation and a higher quality of new bone bridging.
This sleek system allows for straightforward implantation and minimization of tissue disruption when used in accordance with SpineFrontier's angled driver technology.
"The FDA approval of our A-CIFT SoloFuse HA demonstrates SpineFrontier's commitment to providing superior patient care while strengthening our product portfolio with leading industry technologies," said SpineFrontier VP Operations Deepak Pandey, Ph.D.
About SpineFrontier Inc.
SpineFrontier is a growing medical device technology company that designs and develops implants and instruments for spine surgery, based on the Less Exposure Surgery (LES) philosophy. These technologies and techniques are designed to allow for outpatient surgery due to minimal disruption of normal tissue. SpineFrontier is headquartered in Malden, Mass. It is a KICVentures portfolio company and the leader in LES technologies.