Metal replacement in the medical technology arena took another step forward this week with two announcements involving polyether ether ketone (PEEK). In the United States, FDA has cleared the first foot-and-ankle implant made from PEEK-Optima HA Enhanced polymer developed by Invibio Biomaterial Solutions (Thornton Cleveleys, UK). Meanwhile in Germany, chemicals company Evonik (Essen) announced that it has developed an implant-quality, radiopaque PEEK material, which it is adding to its VestaKeep portfolio.
|The first foot-and-ankle implant made with PEEK-Optima HA Enhanced has been cleared by FDA.|
The Vector Hammertoe Correction System from Nvision Biomedical Technologies addresses one of the most common foot-and-ankle procedures, said Invibio, which partnered with the company to develop testing protocols and optimize the manufacturing process of the device. It also provided regulatory support, which resulted in a successful 510(k) submission to FDA.
To date, implantable devices made from PEEK-Optima HA Enhanced have been used exclusively for spinal interventions. Nvision has had a successful track record producing interbody fusion products using Invibio’s polymers. The medical technology company is now expanding its product portfolio to lower extremities.
Innovative features of the foot-and-ankle implant, according to the companies, include the potential of early bone on-growth because hydroxyapatite (HA) is fully integrated, and not just coated, within the matrix of Invibio's PEEK-Optima material. In combination with a modulus of elasticity closely matching that of actual bone, PEEK-Optima HA Enhanced, thus, has the potential to accelerate healing. Its radiolucent properties produce artifact-free imaging to enable easy monitoring of the healing process. Moreover, the finished device gives surgeons the ability to correct hammertoe issues, manifested by a curled-up, calcified toe, with a 100% revisable implant.
Nvision´s new implant enables a standard surgical technique that allows direct drilling and exact placement of the implant while offering several advantages over the conventional K-wire implant procedure. It is also the first lower extremity implant to use Structural Encoding to comply with FDA’s Unique Device Identification requirements. A patented technology licensed from Watershed Idea Foundry, Structural Encoding enables the unique identification of medical devices by means of permanent direct part marking. The technology is able to embed the entire history of the device, and the data can be read by simple X-ray imaging.
Evonik introduces implant-quality, radiolucent PEEK with barium sulfate
|The new VestaKeep grade eliminates artifacts during imaging.|
Compared with Invibio’s milestone, Evonik’s new implant-grade radiopaque material is at the start of its medtech journey, but it can lay claim to an impressive pedigree. The company’s VestaKeep PEEK materials have been used in dozens of FDA-cleared surgical implants over the years. Now, Evonik is offering an implant-quality, radiolucent PEEK with barium sulfate. This formulation eliminates artifacts during imaging. Implants made from the new VestaKeep i-Grade PEEK also will not warm up during magnetic resonance imaging.
I-Grade PEEK materials are available in granulate form or as semi-finished products, such as plastic plates or rods. The grade containing barium sulfate has different compound fill rates to suit various applications.
All VestaKeep products are biocompatible, biostable and easy to process, said Evonik. The high-performance material has a long history in medical technology applications, including spinal implants, sports medicine, cardiovascular devices and maxillofacial surgery.
Finally, as a reminder, Evonik announced the development of an implant-grade PEEK filament for 3D printing in November 2018. At the time, it was only making available a testing grade. The material, complete with documentation needed for regulatory approval, is supposed to be available by the end of this quarter.