The Vector™ Hammertoe Correction System is the first foot and ankle implant made of PEEK-OPTIMA™ Enhanced to be cleared by the U.S. FDA. The correction system is also the first lower extremity (proximal interphalangeal joint arthrodesis) implant to use Structural Encoding® to enable the unique device identification (UDI) required by the FDA. Photo courtesy of Nvision Biomedical Technologies.

Innovative implant from Nvision corrects hammertoe, and expands product offering to lower extremities

THORNTON CLEVELEYS, U.K.—The Vector™ Hammertoe Correction System, a bio-implant from Nvision Biomedical Technologies, a medical device and biologics company, was cleared by the U.S. FDA in March for use in the United States. It is the first foot and ankle implant to be made from the advanced, biocompatible PEEK-OPTIMA™ HA Enhanced, a polymer from Invibio Biomaterial Solutions.

From focusing on spinal implants, Nvision is now expanding its product portfolio to the lower extremities, with the goal to improve patient quality of life in this segment.

“Hammertoe correction is one of the most common foot and ankle procedures, but we realized there are opportunities to improve outcomes,” said Tom Zink, Nvision senior vice president of product development, in a press release. “We have seen real patient success with our interbody fusion product line using Invibio’s PEEK-OPTIMA Natural polymer. Now with our Vector Hammertoe Correction System, we are utilizing the PEEK-OPTIMA HA Enhanced material to translate and expand this innovation in foot and ankle surgeries.”

Nvision has developed the Vector Hammertoe Correction System for Proximal Interphalangeal Joint Arthrodesis to offer innovative features, including the potential of early bone on-growth using PEEK- OPTIMA HA Enhanced. The system also gives surgeons the ability to correct hammertoe issues with a 100 percent revisable implant.

Invibio closely partnered with Nvision to develop testing, and optimize the manufacturing process, while providing support regarding regulatory requirements for the FDA 510(k) submission to obtain clearance for the new implant.

The Vector Hammertoe Correction System is the first lower extremity implant to incorporate Structural Encoding, a patented technology platform licensed from Watershed Idea Foundry that enables the unique identification of medical devices, by means of permanent direct part marking. The technology can embed the entire history of the device, and the data can be read by simple X-ray imaging.

“To date, devices made from PEEK-OPTIMA HA Enhanced have been used exclusively for spinal interventions,” noted John Devine, medical business director for Invibio Biomaterial Solutions. “Nvision’s Vector system is the first time we’ve seen such a device cleared by the FDA for other than spinal applications. What we’ve achieved here, with Nvision and Invibio working as project partners, is a solution for a relatively common but curiously challenging problem, the curled up, calcified toe. The result is a very small device, but one that, for many hammertoe patients, could literally shape a better future.”

Nvision (www.nvisionbiomed.com), based in San Antonio, Texas, is a medical device and biologics company focused on providing surgeons with implants paired with instrumentation and biologics that simplify and improve surgery procedures to help patients get back to their quality of life.

Victrex (www.victrex.com) is a developer of high performance PAEK and PEEK polymers, and is focused on the automotive, aerospace, energy (including manufacturing and engineering), electronics, and medical markets.

Subscribe Now

Design-2-Part Magazine

Get the manufacturing industry news and features you need for free in a format you like.

FREE Print, Digital, or Both »

You have Successfully Subscribed!