BioPoly® Receives CE Mark for Trochlear Groove Implants
FORT WAYNE, IN – BioPoly has just announced that its BioPoly® RS Partial Resurfacing Trochlea System is now CE marked, expanding the implant offering of the BioPoly® RS Partial Resurfacing portfolio. With the addition of the RS Trochlea implants, the BioPoly® RS Partial Resurfacing Knee System now offers treatment options for focal cartilage defects in the femoral condyles, trochlear facets, trochlear groove, and patella.
The BioPoly trochlea product line consists of multiple implant variations to cover a broad range of defect sizes and to account for variations in patient knee anatomy. Similar to the BioPoly knee and patella, the BioPoly trochlea is minimally invasive and tissue sparing. “We are very excited to make our new BioPoly RS Trochlea Implant available to the market. Surgeons have indicated the need, and our team has responded quickly with a very innovative solution,” said Sheila Schwartz RPh, Vice Pres of Operations at BioPoly. The Company plans to launch the new trochlea implant in the coming months.
BioPoly® combines a synthetic polymer (ultra-high molecular weight polyethylene) with hyaluronic acid, a lubricating molecule found in joint fluid, thus, creating a “self-lubricated” polymer that is extremely biocompatible with native tissues such as cartilage and meniscus. After it is implanted, the BioPoly® material attracts joint fluid to its surface for lubrication, similar to native cartilage. Thus, BioPoly implants function as synthetic cartilage and can be used to replace damaged cartilage (i.e. partially resurface) in joints. The BioPoly family of partial resurfacing products (RS Knee, RS Patella, RS Trochlea, and RS Shoulder) are CE marked; however, they are not yet FDA approved or cleared for use in the US.
About BioPoly LLC
BioPoly LLC is an ISO 13485 certified orthopaedic implant manufacturer located in Fort Wayne, Indiana. The Company is developing, manufacturing and marketing products for use in sports medicine, orthopaedics, and spinal markets. Additional medical applications of the BioPoly® technology in cardiovascular and trauma markets are also being pursued.