Claret Medical is just two years old, but the Santa Rosa med-tech startup already is finding success with a new device for preventing strokes in heart patients.
It's the latest example of innovation in Sonoma County's medical technology sector, which has weathered the recession better than other parts of the economy.
Medical technology has the potential to succeed telecommunications as a powerful job engine in Sonoma County, said Saeid Rahimi, dean emeritus at Sonoma State University's School of Science and Technology.
"I'd call it the second wave after telecom," he said. "I have great hope for it."
Today, Sonoma County has 10 medical technology companies with about 1,200 workers. The industry's growth is driven by an aging population and the need for cost-effective, less-risky medical procedures, said Steve Weiss, a Healdsburg biotech entrepreneur and investor.
"A lot of these technologies are replacing older, invasive hospital procedures," he said. "If you can move a patient from a high-cost hospital setting, you're improving safety and saving the system huge dollars."
Venture funding for medical technology startups has held steady, despite an overall slump in private equity deals, said Weiss, co-founder of North Bay Angels, a Sonoma County group that invests in early-stage tech companies.
Claret reached a milestone last week when it received regulatory approval to market its Montage filtration system in Europe.
The Montage device is used in Transcatheter Aortic Valve Intervention (TAVI), a next-generation technology for replacing damaged heart valves without risky open-heart surgery.
The TAVI 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.
While the procedure is safer than open-heart surgery, it can dislodge particles that travel to the brain, causing stroke in a small percentage of patients.
Claret's new device is designed to reduce stroke risk during the procedure. With Montage, a physician uses a small catheter to insert two small filters into the carotid arteries, catching debris before it can reach the brain.
European approval was based on Claret's successful clinical trials outside the United States.
"We're catching debris in almost all of the filters," said Randy Lashinski, the startup's founder and CEO. "It gives physicians and patients an option for reducing embolic events in interventional procedures."
Lashinski is a Sonoma County med-tech veteran who led research and development at Santa Rosa's Arterial Vascular Engineering. That business was sold to Medtronic in 1999 for $3.7 billion.
He also worked for Medtronic before co-founding Direct Flow Medical, a Santa Rosa startup that is developing a transcatheter heart valve.
Lashinski got the idea for Claret after leaving Direct Flow in 2008. A German physician, Dr. Eberhard Grube, approached him about the need to reduce stroke risk in vascular intervention procedures such as TAVI.
Two years of research, development and clinical testing led to Claret's European approval. Investors have put a little less than $5 million into the startup.
"The Montage system is an exciting new step forward to potentially reduce stroke rates in TAVI and other vascular procedures," said Grube, who heads the structural heart program at University Hospital in Bonn. "It has the potential to change the way physicians view TAVI in their practice."
Claret has about a dozen workers in Santa Rosa and is adding employees as it gears up for commercialization outside the U.S. Its next goal is U.S. market approval, but it hasn't set a timeline.