Nvision’s foot and ankle implant cleared by the FDA

The first foot and ankle implant made from PEEK-OPTIMA HA Enhanced has been cleared by the Food and Drug Administration (FDA).

With the goal to improve patient quality of life, Nvision Biomedical Technologies, a medical device and biologics company is now expanding its product portfolio to lower extremities.

Nvision has had its bio-implant, the Vector Hammertoe Correction System cleared by the FDA for use in the United States.

The implant is made from the advanced, biocompatible polymer PEEK-OPTIMA HA Enhanced from Invibio Biomaterial Solutions. It is the first foot and ankle implant to be made from this material, aswell as being the first lower extremity (proximal interphalangeal joint arthrodesis) implant to use structural encoding to enable the Unique Device Identification (UDI) required by the FDA.

"Hammertoe correction is one of the most common foot and ankle procedures, but we realised there are opportunities to improve outcomes," said Tom Zink, Nvision senior vice president of product development. "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 utilising the PEEK-OPTIMA HA Enhanced material to translate and expand this innovation in foot and ankle surgeries.”

Nvision’s Vector Hammertoe Correction System has been developed for proximal interphalangeal joint arthrodesis in order to offer innovative features including the potential of early bone ongrowth using PEEK-OPTIMA HA Enhanced. The system also provides surgeons with the ability to correct hammertoe issues with a 100% revisable implant. The system is able to embed the entire history of the device, and the data can be read by simple X-ray imaging.

Invibio partnered with Nvision in order to develop testing and optimise the manufacturing process. Invibio also provided support regarding regulatory requirements for the FDA 510(k) submission to obtain clearance for the new implant.

"To date, devices made from PEEK-OPTIMA HA Enhanced have been used exclusively for spinal interventions. Nvision's Vector system is the first time we've seen such a device cleared by the FDA for other than spinal applications," noted John Devine, medical business director, Invibio Biomaterial Solutions. "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."

The surgeon's primary goal for hammertoe surgery is to provide a potential solution for fusion across the joint, and PEEK-OPTIMA HA Enhanced is able to do this. It is possible due to hydroxyapatite (HA) which is fully integrated within the matrix of Invibio's PEEK-OPTIMA Natural, which means that the HA is available on all surfaces of a finished device.

PEEK-OPTIMA HA Enhanced also has the potential to promote bone ongrowth and healing in combination with a modulus of elasticity closely matching that of actual bone. Its radiolucent properties result in artifact-free imaging with the ability to easily monitor the healing process.

The Vector Hammertoe Correction System offers considerable advantages over a conventional K-wire implant procedure. These advantages include a press fit between the implant and the bone since the cavity is accurately drilled and controlled, ease of insertion promoted by the precision instrumentation of the Vector system which further improves the success of the procedure and a greater pull-out force than other PEEK hammertoe implants as a result of the structurally encoded pin once pressed into position.

Nvision believe that PEEK-OPTIMA HA Enhanced is the perfect material for hammertoe correction. Nvision state that the strong fusion is a result of the small cross sectional area of the intermediary canal which is able to promote osteointegration on the implant.

Nvision and Invibo will both be attending the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting from March 13th to March 15th 2019 on booth #4861, and booth #2829 respectively.