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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.

And medical device makers are striving to develop and bring to market less invasive procedures to fix the heart’s other valves.

Twenty years ago, Santa Rosa stent maker Arterial Vascular Engineering made national news when it was acquired by Medtronic for $3.7 billion.

The 1998 purchase was one in a brief series of acquisitions that put exclamation marks to some key scientific breakthroughs by local companies. They included Cisco Systems’ $7 billion buyout of Petaluma-based telecom startup Cerent in 1999 and JDSU’s $6.2 billion purchase of thin-film coating maker Optical Coating Laboratory Inc. of Santa Rosa the following year.

In roughly seven years, AVE grew from a startup in a rented warehouse to the world’s leading maker of coronary stents and one of the North Coast’s larger employers.

The global medical device market today is valued at $389 billion, according to medical market research group Kalorama Information. The industry includes 40 different segments with such diverse items as hip implants, pacemakers, intraocular lenses and minimally invasive surgical devices.

AVE is credited with helping spawn a handful of smaller device makers that operate in Sonoma County today.

“We are kind of one of those hot spots for medical devices on the West Coast,” said James Hallums, Claret’s chief commercial officer and a former AVE employee.

After his time at AVE, Lashinski went on to help start such companies as MitraLife, Direct Flow Medical, Claret Medical and Millipede. His hope, he said, is that the engineers, researchers and technicians at the local firms today will go on to launch their own startups.

Such new companies, he said, will “keep Sonoma County strong and continue as the hotbed environment for medical device engineering.”

Many of the local companies have built upon advances dating back a half-century and linked to the use of catheters to dilate narrowed blood vessels. The early efforts, with the catheter passing through a small incision in the groin, led to the use of balloon angioplasty to better enlarge the vessel and mesh stents to keep it open.

Companies now are using catheters as less invasive ways to replace heart valves and to employ special filters during valve procedures to capture debris that can cause strokes.

The local businesses include Relucent, a Santa Rosa stent and device maker that was acquired in 2016 by a subsidiary of Maruho Hatsujyo Kogyo of Kyoto, Japan. Another is a Santa Rosa division of Irvine-based Endologix, which in 2015 merged with local stent graft maker TriVascular Technologies.

By far the largest presence here is Medtronic, which is based in Dublin, Ireland, and has its operational headquarters in Minneapolis. The local branch, part of Medtronic’s Cardiac and Vascular Group, employs a total of about 1,000 workers, including 840 permanent employees.

Three of its four facilities have their own research and development labs. Manufacturing linked to the company’s aortic and vascular devices takes place at its Brickway Boulevard facility off Airport Boulevard, while testing of drug coated balloons is conducted at its Fountaingrove location.

While Medtronic first acquired an aortic valve developed by Irvine-based CoreValve, a team in Santa Rosa help lead the development of the second and third generations of its TAVR system. Both researchers and those assigned to regulatory issues in Santa Rosa continue to help with the company’s TAVR program.

“The group in Santa Rosa is also working very hard on the mitral valve,” said Kappetein, the chief medical officer.

He was referring to the Intrepid transcatheter mitral valve replacement system, which Medtronic last fall announced was undergoing a key trial in up to 1,200 patients.

Claret Medical reported that a total of 6,000 patients to date have benefited from its Sentinel filter system while undergoing TAVR procedures. The device is manufactured in Santa Rosa.

The system employs a catheter that is thinner than a standard headphone cord for a mobile phone. It is inserted into a blood vessel in the patient’s right wrist. The filters are directed and placed inside the two major arteries that supply blood to the brain, where they can catch debris that commonly is dislodged during TAVR.

In a random, controlled trial, the device reduced strokes by 63 percent in the first 72 hours after TAVR, the company reported last June.

Hallums, Claret’s chief commercial officer, said TAVR will account for nearly half of aortic valve replacements conducted this year. But the number of surgical valve replacements should keeping dropping, and roughly three fourths of aortic valve patients are expected to rely on TAVR by 2025.

Among those offering TAVR is Santa Rosa Memorial Hospital, which since January has used the less invasive system to replace aortic valves in eight patients. All the procedures went well, Coleman said, with no strokes and no bleeding problems for the patients.

The first TAVR devices were approved for U.S. patients in 2011, with Medtronic entering the market in 2014. Coleman noted the team at Memorial worked six years to gain approval to use the procedure and last year satisfied all the requirements of the federal Medicare system.

Memorial hasn’t used Claret’s Sentinel filtering system for its TAVR procedures. However, Coleman called the Sentinel “a great device, and it’s certainly something that we’re looking at.”

Those who suffer from malfunctioning aortic valves, a condition known as aortic stenosis, have only a 50 percent survival rate if left untreated for two years, Coleman said. TAVR allows valve repairs for frail patients and those who balk at the idea of open heart surgery.

“To me this represents a huge leap forward for all the patients who live in our region,” he said.

You can reach Staff Writer Robert Digitale at 707-521-5285 or robert.digitale@pressdemocrat.com. On Twitter @rdigit.

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