Cayenne Medical Launches Second Generation Knee Repair Device

Sometimes, life is all about timing. For medical device companies, timing can be crucial, particularly when it comes to new product launches.

Executives with Cayenne Medical Inc. recently demonstrated the efficacy of good timing when they launched the company’s second generation soft tissue knee repair device during the 2011 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in San Diego, Calif.

The AperFix II system for multi-ligament repairs of the knee improves upon Cayenne’s AperFix ligament reconstruction technology, which utilizes 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 U.S. Food and Drug Administration in 2007—creates a shorter, stiffer and more anatomic ligament repair. Since its debut four years ago, the company’s technique has been validated by several studies, including a Harvard clinical analysis published in March 2009 which found that Cayenne’s AperFix reconstruction technique better resembled the natural intact anterior cruciate ligament (ACL) when compared to more common, single-bundle techniques.

The AperFix II introduces a Cannulated Tibial System to the original AperFix technique, providing surgeons with an easier insertion method and standardized positioning of the implant. In ACL repairs, the next-generation 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. New enhancements to the femoral device also make it easier for surgeons to insert and place the graft within the tunnel.

“The AperFix II System offers a simple and efficient technique to obtain consistent circumferential graft compression, restoring native knee kinematics,” noted Kenneth Montgomery, M.D., an orthopedic surgeon with Morristown, N.J.-based Tri-County Orthopaedic & Sports Medicine Inc. “I believe this procedural enhancement will ensure the integrity and strength of the reconstructed ligament, providing patients with a more stable knee.”

More stable knees isn’t the only benefit of the AperFix II system. Executives told Orthopedic Design & Technology that the device can help patients with ACL injuries recover faster, which can be a godsend for amateur athletes and weekend warriors anxious to return to the playing fields (or courts). Patients also don’t have to worry about revision surgeries when undergoing an ACL procedure using the AperFix system (the original)—the device has a significantly lower revision rate than other ACL repair products and methods. Timothy S. Nash, vice president of marketing for the Scottsdale, Ariz.-based firm, estimated the revision surgery rate for patients treated with the AperFix system to be less than 1 percent; revision surgery rates for other ACL repair devices range from 7 percent to 12 percent, he said.

“As the industry continues to lean in favor of soft tissue ligament reconstruction, we have seen much success with our flagship product AperFix and an increasing interest in its anatomic repair through aperture graft fixation,” said James W. Hart, Cayenne Medical’s executive chairman. “The enhancements we’ve made to the tibial portion of the procedure with AperFix II are in line with this trend and affirm our commitment to evolving our technology platform for the benefit of surgeons and their patients.”

The AperFix II Cannulated Tibial System is comprised of the tibial implant made from PEEK (Polyether ether keytone) polymer, a tendon expander, a guidewire, a cannulated screw and a driver pre-loaded with tibial sheaths and a sheath holder.

Founded in 2005, Cayenne Medical is a privately held company that develops soft tissue reconstruction technology and devices for the sports medicine market.