Reinventing the valve at Medtronic

<p>Gathered around a pulsating model of a human heart, scientists and engineers at Medtronic Inc. in Santa Rosa are inventing next-generation technology for replacing damaged heart valves without risky surgery.</p><p>There's a potential $3.5 billion global market for such technology, aimed at patients who are too sick to undergo conventional open-heart surgery, according to Medtronic.</p><p>"There's a huge unmet need for patients who don't qualify for surgery," said Don Osborn, director of the Santa Rosa project.</p><p>The new technique lets a doctor deliver an artificial heart valve through a patient's femoral artery, located near the groin, using a tube-and-wire catheter system.</p><p>Medtronic, the world's largest medical device maker, already has invested more than $1 billion in the technology, acquiring two companies that make transcatheter heart valves.</p><p>Minneapolis-based Medtronic wants to be the leader in nonsurgical heart valve replacement, said company spokesman Joe McGrath.</p><p>"This is a big play for us," he said.</p><p>It's also a new direction for Medtronic's Santa Rosa facility, acquired from Arterial Vascular Engineering in 1999 for $3.7 billion.</p><p>Santa Rosa is headquarters for Medtronic's vascular business, which develops stents and stent graft systems for treating artery disease. Stents are tiny metal mesh tubes implanted in heart patients' arteries to keep their blood flowing.</p><p>While vascular technology still dominates in Santa Rosa, the 840-employee facility is now devoting attention to structural heart disease, McGrath said.</p><p>The move follows the 2007 merger of the vascular unit with Medtronic's cardiac surgery division. Santa Rosa is evolving from a manufacturing facility to a launching pad for new technology, he said.</p><p>"We're serious about transforming Santa Rosa into a center of excellence for research and development," McGrath said.</p><p>The heart valve replacement project builds on Santa Rosa's expertise in catheter delivery, which is also used in stent procedures.</p><p>Currently, no transcatheter heart valves are available in the United States. But Medtronic hopes to have two versions ready for the domestic market in 2014, said Dr. John Liddicoat, a cardiac surgeon who heads the company's structural heart business.</p><p>"We have the market-leading technology," he said. "Santa Rosa is focused on our next-generation device."</p><p>In April, Medtronic paid $700 million to acquire CoreValve Inc., an Irvine company that pioneered transcatheter heart valve replacement in 2004. In the past five years, CoreValve's system has been used in 5,000 heart patients outside the United States.</p><p>CoreValve technology will help Medtronic scientists develop a new generation of products, Osborn said.</p><p>"Our toolbox has expanded dramatically," he said.</p><p>Most coronary valve repair and replacement is done by open-heart surgery, which stops the heart and carries the danger of serious complications. Many patients who need such procedures don't get them because they're not healthy enough to bear the risks.</p><p>CoreValve has the potential to treat 300,000 patients with severe aortic stenosis, a narrowing of the aortic valve that causes crippling pain and weakness, according to Medtronic.</p><p>The replacement aortic valve is made from porcine pericardial tissue -- from the sack surrounding the pig's heart -- that's sewn into a frame made of special self-expanding metal. The device is placed on the tip of a tubelike catheter that's inserted in the transfemoral artery, which starts near the groin.</p><p>Using a guide wire, a physician snakes the device through the patient's artery to the heart. It's then positioned in the aortic valve and expanded in place of the old valve while the patient's heart continues to beat.</p><p>At a major conference on cardiovascular technology in San Francisco last week, Medtronic said studies in Europe, Canada, Australia and New Zealand show the CoreValve method is safe and effective.</p><p>In Santa Rosa, about two dozen scientists, engineers and technicians are refining the system. In a laboratory near Charles M. Schulz-Sonoma County Airport, they're testing prototypes on a model that simulates the heart's anatomy. Instead of blood, however, the heart pumps water.</p><p>The testing is aimed at making the system more accurate and easy for physicians to use, Osborn said.</p><p>Medtronic already was working on transcatheter aortic valve technology when CoreValve became part of the company, he said. CoreValve's addition has given the project a major boost, Osborn said.</p><p>"We're going to end up with a great next-generation product," he said.</p><p>Meanwhile, Medtronic acquired a second aortic valve maker, Ventor Technologies. Its system, which uses a different point of entry, is undergoing clinical trials in Europe.</p><p>And the company is waiting for FDA approval of a third device, the Melody pulmonary valve, for patients who have congenital heart disease.</p><p>Medtronic plans to have nonsurgical replacements for all four of the heart's valves -- aortic, mitral, pulmonic and tricuspid, Liddicoat said.</p><p>"We're covering the full spectrum of approaches," he said.</p><p>-- You can reach Staff Writer Steve Hart at 521-5205 or steve.hart@pressdemocrat.com.</p>