On-X Life Technologies, Cleveland Clinic enter into an exclusive worldwide license agreement

Austin-based On-X^® Life Technologies, Inc. (On-X LTI), manufacturers of the On-X^® Prosthetic Heart Valve, announced today that it has entered into an exclusive worldwide license with the Cleveland Clinic for a system of products intended to improve and simplify the replacement of damaged or severed mitral valve chordae. The system is the creation of co-inventors A. Marc Gillinov, M.D., a staff cardiac surgeon at Cleveland Clinic, and Michael K. Banbury, M.D., of Christiana Care’s Center for Heart and Vascular Health, and will be co-developed with the On-X LTI New Product Development team.

Surgical repair of the mitral valve includes the insertion of a cloth-covered ring around the valve to bring the leaflets into contact with each other (annuloplasty), removal of redundant/loose segments of the leaflets and re-suspension of the leaflets with artificial cords (chordal replacement). Replacement of diseased mitral valve chordae with expanded polytetrafluoroethylene (ePTFE) sutures is an established technique with good long-term results. Various techniques have been described to assist the surgeon to establish the correct replacement chordal length.

“For the past three decades, there has been great focus on the roles of leaflet resection and annuloplasty for mitral valve repair in patients with mitral valve prolapse. More recently, surgeons have recognized the value of using artificial chordae to correct prolapse,” said Dr. Gillinov. “With current techniques, chordal replacement is technically challenging. The hope is to assist cardiac surgeons by providing a simple method for chordal replacement.”

“The surgical approach to mitral valve repair appears to be a method by which a long-term satisfactory outcome can be achieved,” said Dr. Banbury. “It is our expectation that the surgical tools we will develop with On-X LTI will further enable the surgical approach and enhance the consistency of surgical outcomes, providing patients with the best opportunity for a solution to their mitral incompetence.”

Approximately 50,000 mitral valve repair procedures are performed annually in the United States. Mitral valve repair is one of the fastest growing procedures in cardiac surgery due to the excellent long-term outcome. In a minority of cases the mitral valve may not be surgically repaired and must be replaced with a prosthetic valve.

“Cleveland Clinic, and Drs. Gillinov and Banbury are recognized leaders in the delivery of excellent heart surgery results,” said Clyde Baker, On-X LTI president and CEO. “The opportunity for On-X LTI to work with them and to develop this important new surgical system not only enhances the future product offerings of On-X Life Technologies, but also provides us with new insight into the future of heart valve treatment. We are extremely pleased to enter into this relationship and expect that surgeons and patients will receive meaningful value from the delivery of these innovative products.”