MINNEAPOLIS, MN, October 1, 2001 – Medtronic, Inc. (NYSE: MDT), today announced the U.S. and European launch of the Colvin-Galloway FutureÔ band, a new surgical product particularly adapted to assist in annuloplasty, the surgical repair of the heart’s mitral valve.
The mitral valve is one of the primary controllers of blood flow in the heart. Flow of oxygenated blood from the lungs into the main pumping ventricle of the heart is controlled by the dome-shaped mitral valve. Weakness, shortness of breath, excessive perspiration, and nausea are common symptoms of mitral valve insufficiency, which is sometimes congenital but may also be caused by tissue overgrowth, infection, or damage from heart attacks.
Now available for general use, the Colvin-Galloway Future band is a semi-rigid device implanted by a cardiothoracic surgeon to support the posterior portion of a mitral valve after surgical repair to correct stenosis (narrowing) or regurgitation (leaking). The C-G Future band’s features include a firm yet flexible construction, low bulk, unique anchoring eyelets, and a profile that is 20 percent lower than other available semi-rigid devices.
Aubrey Galloway, M.D., Professor of Surgery, Director of Cardiac Surgical Research at New York University and co-developer of the new product, said, “The C-G Future band is a significant advance over prior devices used for valve repair – its low-profile facilitates easier implantation and its strong yet flexible metal core facilitates more predictable remodeling, both of which will be advantages in all cases, but will be especially valuable as more advanced minimally-invasive techniques become more common.”
For mitral valves, surgeons are increasingly opting for repair – or annuloplasty – to correct valve damage or degeneration. More than 50,000 surgeries are performed worldwide annually to treat mitral valve insufficiency. Of the approximately 31,000 U.S. mitral valve surgeries recorded in the national database of the Society of Thoracic Surgeons for 2000, about 11,000 were for repair. The increasing refinement of minimally invasive surgical techniques and instrumentation - aided by the intraoperative visibility now afforded by transesophageal echocardiography and the introduction of lower-profile products such as the C-G Future band - is expected to rapidly increase this number.
A growing body of evidence also supports the case for mitral valve repair, illustrating shorter hospital stays, less need for anticoagulant therapy, and lowered mortality rates. A recent study conducted at the Mayo Clinic found that more than 90 percent of patients referred for mitral valve regurgitation undergo repair instead of replacement, and that the success rate was 95-99 percent.
During mitral valve repair, the surgeon’s goal is to restore, or “remodel,” a narrowed, prolapsed or leaking mitral valve opening to a more-normal shape and alignment. If this is accomplished, the pressure of blood closes the valve tightly as the heart contracts, but allows the valve to open for blood to flow through it when the heart relaxes. The innovative C-G Future band restores proper “coaptation,” or closure, of the mitral valve leaflets. The semi-rigid radiopaque device is constructed of a strong but flexible metal alloy that holds the valve in the “remodeled” shape. Unique eyelets facilitate suturing and secure anchoring.
Bob Guezuraga, president of Medtronic Cardiac Surgery, said, “Today’s introduction of the C-G Future band reinforces both Medtronic’s commitment to providing a range of solutions for patients suffering from heart valve disease, as well as advancing the adoption of minimally invasive techniques in the surgical suite. We look forward to our continued partnership with physicians worldwide in advancing both treatments and techniques.”
With the addition of the C-G Future band, Medtronic Cardiac Surgery offers the world’s most complete array of products for valve replacement and repair. The repair line also includes the popular Duran Flexible annuloplasty ring and system components along with the Duran Flexible annuloplasty band. For total replacement, Medtronic offers the popular HancockÒ II tissue valve, the MosaicÒ tissue valve, the stentless FreestyleÒ tissue valve and the Medtronic HallÒ mechanical valve.