The standard way to repair a leaky mitral heart valve is to crack open the patient’s sternum and bring in the open heart surgeon.
A Santa Rosa medical device startup named Millipede has developed a less invasive approach. It involves a zigzag-shaped ring of nickel-titanium alloy that adjusts typically to a size slightly larger than a quarter when set in place.
A doctor can use a special catheter delivery system to advance the collapsed ring up a blood vessel to the patient’s heart. Once in position, the ring has eight tiny corkscrew anchors and eight adjustment collars. By twisting the 16 small knobs on the opposite end of the delivery system, the physician can implant each anchor and properly cinch each collar adjustment — thereby shrinking the heart valve’s diameter to a point where the mitral’s twin leaflets stop leaking.
Patients with malfunctioning mitral valves one day will forgo surgery and say, “Doc, stick me with this catheter,” predicted Randy Lashinski, Millipede’s CEO, and a part of Sonoma County’s medical device sector since he joined the former Arterial Vascular Engineering in 1995.
The local medical device industry has marked some noteworthy developments in the past year. Among them:
Massachusetts-based Boston Scientific agreed in January to invest $90 million in Millipede — purchasing a potion of shares in the 6-year-old startup and obtaining an option to acquire complete ownership. Millipede, with 22 full-time workers, has implanted the IRIS transcatheter annuloplasty ring in about 15 patients and plans to eventually conduct full-scale clinical studies in order to win U.S. and European approval for commercial use.
Santa Rosa Memorial Hospital in January conducted its first procedure to replace a patient’s aortic heart valve through a less invasive process known as transcatheter aortic valve replacement, or TAVR. The implanted device, the CoreValve Evolut PRO valve, is a Medtronic product that has been refined and improved with the help of researchers at the company’s Santa Rosa facilities.
Santa Rosa’s Claret Medical last June received approval from the U.S. Food and Drug Administration to sell a minimally invasive device that reduces strokes by using tiny filters to capture debris dislodged during valve replacement procedures. Claret’s Sentinel cerebral protection system is the only such device approved in the U.S. and Europe for use during TAVR, the company says.
It typically take years of research and testing before such innovations affect patient lives. But proponents point to breakthroughs like TAVR as life-changing advances in medicine.
“This is a revolutionary thing,” said Dr. Patrick Coleman, the interventional medical director of the TAVR program at Memorial. “This is changing the whole way a huge part of the population is getting treated.”
A patient who undergoes open heart surgery for aortic valve replacement typically needs a week’s stay in the hospital and two to three months of recovery at home, said Dr. Pieter Kappetein, chief medical officer of Medtronic’s TAVR program. In contrast, those whose valves are replaced under the less invasive procedures regularly leave the hospital within three days and generally need only two to three weeks of recovery.
Some of these mostly aging patients still will require open heart surgery, Kappetein said. But the day is coming when the large majority of them will have aortic valves replaced by catheters.