Broken Hearts Get Gentler Touch With Medtronic, Edwards Valves
Thomas, a cardiologist at St. Thomas Hospital, fixes diseased heart valves in a way that allows patients to avoid open-heart surgery. The technique employs devices made by Medtronic Inc. of Minneapolis and Edwards Lifesciences Corp., based in Irvine, California. The two companies are racing to bring the technology to the U.S., the key to a worldwide market Medtronic says may top $2 billion annually within five years.
The method may aid as many as 10,000 patients this year in Europe, where regulators allowed the devices on the market without clinical trials for the weakest patients. Doctors there are years ahead of their American counterparts, who must await research results and U.S. approval before using the valves.
“This is a mind-boggling technology, where patients come in very sick and they walk out of the hospital with an excellent quality of life,” said Rob J.W. ten Hoedt, Medtronics head of European and Central Asian operations. “Europe is having a party with these new products.”
Medtronic rose 28 cents, or 0.8 percent, to $36.20 yesterday in New York Stock Exchange composite trading and has fallen 31 percent in the 12 months before today. Edwards fell 1 cent to $64.93 and has gained 4.4 percent in the past year.
The U.S. Food and Drug Administration will make approval contingent on a study to prove the valves are at least as effective, and as safe, as traditional care. Doctors in the U.S. recognize the FDAs need for caution, said Murat Tuzcu, an interventional cardiologist and vice chair for clinical operations at the Cleveland Clinic.
Aortic Valve
“There is an untapped population, and this technology may open the floodgates in the U.S.,” Tuzcu said in an interview. “We need to get the information, and the FDAs rigorous oversight is going to give us the best data.”
Traditional repair requires surgeons to stop the heart and make an incision running the length of the chest to get access to the valve that controls the flow of oxygen-rich blood to the body. The narrowed and calcified aortic valve is cut out, and a $5,000 replacement is sewn into place. The surgery is effective, with valves lasting 15 years or longer, said Larry Wood, Edwardss corporate vice president of transcatheter valve replacement.
Thomas, an interventional cardiologist and valve pioneer, instead threads a specially designed $25,000 valve into a beating heart through an artery in the leg or a small incision in the ribs. In some cases, the heart is directly pierced at the apex with a hollow-nosed needle, allowing doctors to insert a guide wire and wind it through the organs chambers. The replacement valve, crimped onto a catheter, follows the wire as it is fed into place.
Lethal Condition
The procedure has been performed for less than five years, leaving questions about the comparative safety of the surgery and the durability of the valve, which must open and close 40 million times a year. Medical regulators in Europe limit the operation to patients who cant easily tolerate open-heart surgery to repair their diseased valves.
European Union regulators, who set rules for 27 countries, cleared the devices from Edwards and Medtronic in 2007. The valves may generate $200 million in sales this year in Europe, the only place where they are approved, according to forecasts from Medtronic and Edwards. The world market will be larger, the companies say.
Market Opportunity
“There is no doubt this is a $2 billion to $2.5 billion market in the population we have today,” mainly patients older than 75 and others who couldnt tolerate open-heart surgery, ten Hoedt of Medtronic said in an interview. “If we go younger, to age 65, that market opportunity will grow exponentially.”
Surgeons are still unsure of the death and complication rates, including strokes, aortic rupture, bleeding and migrating valves, in patients who undergo the procedure. A registry tracking patients in Europe showed a 78 percent survival after one year in patients getting the valve through an artery, and 50 percent for sicker patients treated through the ribs.
Edwards began a clinical trial of its Sapien valve in 2007, putting it at least two years ahead of its main rival, Medtronics CoreValve, in progress toward the U.S. market. The results may be available next year, according to Edwardss Wood.
Relieving Symptoms
The procedure relieves symptoms for patients who dont qualify for a traditional operation, Thomas said. Researchers are studying whether it will prolong life and reduce subsequent medical costs by helping patients avoid repeated hospitalizations as the disease worsens, he said.