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Kensey Nash Submits IDE Application For Cartilage Repair Device To FDA

Kensey Nash Corporation announced that the company has submitted an Investigational Device Exemption (IDE) application to the US FDA to study the use of the novel biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will utilize the Kensey’s Cartilage Repair Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions. The device is a composite of several bioresorbable biomaterials, utilizing Kensey's proprietary collagen technology, and beta-tricalcium phosphate mineral suspended in a synthetic polymer Porous Tissue Matrix (PTM). Cartilage Repair Device is intended to repair damaged articular cartilage in the knee or other articulating joints. This Cartilage Repair implant is housed in an insertion tool, which facilitates arthroscopic insertion, allowing the surgeon to avoid open procedures. The design also allows implants to be cut to length and easily hydrated with autologous blood products. The company has also developed a full complement of specialized color-coded instruments to estimate implant size and prepare the defect site for the delivery of this proprietary bi-phasic implant.