Cayenne Medical has launched its "second-generation" soft tissue knee repair device, the AperFix II system, in the US. The cannulated tibial system is comprised of the tibial implant made from PEEK polymer; a tendon expander; a guidewire; a cannulated screw and a driver pre-loaded with tibial sheaths and a sheath holder.
The AperFix II system, which is designed for multi-ligament repairs of the knee, is based upon the company's ligament reconstruction technology, which uses a single tunnel, all-inside approach for attaching the soft tissue graft at the aperture of the femoral and tibial tunnels. The technique - approved by the FDA in 2007 - creates a shorter, stiffer and more anatomic ligament repair. The system introduces a cannulated tibial system to the original technique, providing surgeons with an easier insertion method and standardised positioning of the implant. In ACL repairs, the system allows for the rotation of two tendons representing the anteromedial and posterolateral bundles to more accurately match the positioning of the native ACL bundles. Enhancements to the femoral device also make it easier for surgeons to insert and place the graft within the tunnel.
The updated system can also help patients with ACL injuries recover faster, and the device has a significantly lower revision rate than other ACL repair products and methods. It is estimated the revision surgery rate for patients treated with the AperFix system to be less than 1 per cent; revision surgery rates for other ACL repair devices range from 7 to 12 per cent.