NVISION Biomedical Technologies

NVISION Biomedical Technologies Receives First FDA Clearance for an Osteotomy Wedge System Made of PEEK-OPTIMA™ HA Enhanced

A growing lower-extremity product portfolio made with an innovative bone-ongrowth biomaterial

San Antonio, Texas and Thornton Cleveleys, United Kingdom
October 28, 2020

NVISION Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, has received FDA clearance for the first osteotomy wedge system made from PEEK-OPTIMA™ HA Enhanced, a polymer from Invibio Biomaterial Solutions.

The Trigon® Stand-Alone Osteotomy Wedge Fixation System has osteoconductive properties designed to promote multidirectional bone healing and improved fixation without introducing material-related biocompatibility reactions. Additionally, the Trigon system utilizes Structural Encoding® to support the Unique Device Identification requirements established by the FDA.

“NVISION’s Trigon Osteotomy Wedge System, along with the entire foot and ankle line, incorporates multiple technologies that I believe will be major factors in the future of reconstructive distal extremity surgery.”

Made from PEEK-OPTIMA HA Enhanced, the Trigon system supports a standard surgical technique that allows direct and precise placement of the implant and screws without additional plating. NVISION collaborated with Invibio on the FDA 510(k) submission to obtain clearance for the new implant.

PEEK-OPTIMA HA Enhanced offers the potential for earlier fusion or union in foot and ankle procedures, a primary objective in fusion surgery. Hydroxyapatite, or HA, is fully integrated into the matrix of Invibio’s PEEK-OPTIMA Natural. Because the HA is integrated rather than applied as a coating, it is present on every surface of the finished device.

Combined with a modulus of elasticity closely matching that of natural bone, PEEK-OPTIMA HA Enhanced has the potential to promote faster bone ongrowth and healing. Its radiolucent properties also provide artifact-free imaging, allowing clinicians to monitor the healing process more easily.

After initially focusing on spinal implants, NVISION expanded its advanced technologies into lower-extremity surgery with the March 2019 launch of the Vector® Hammertoe Correction System.

An industry first, the hammertoe system was the first foot and ankle implant made from the advanced, biocompatible PEEK-OPTIMA™ HA Enhanced material. It was also the first lower-extremity proximal interphalangeal joint arthrodesis implant to incorporate Structural Encoding, a patented technology platform licensed from Watershed Idea Foundry.

Earlier in 2020, NVISION also introduced the Trigon titanium wedge, manufactured using additive manufacturing and 3D-printed medical-grade titanium alloy, Ti-6Al-4V.

“The ability to innovate with advanced materials, designs, and manufacturing processes allows us to add products to our portfolio that give surgeons the opportunity to achieve the best outcomes for their patients.”

With an ongoing focus on innovation in the foot and ankle segment, NVISION has several additional products in development that utilize PEEK-OPTIMA HA Enhanced material.