New CEO says Direct Flow Medical on the right track

The new chief executive for Santa Rosa’s Direct Flow Medical says the company is proving itself a “fast follower” in the competitive and growing market of devices that replace human heart valves without invasive surgery.

The privately held business continues to post strong results for European patients that have received its Transcatheter Aortic Valve System, President and CEO Dan Lemaitre said Monday.

Such patients, many of them in their 80s, are judged too frail to undergo valve replacement via open-heart surgery. Of 200 patients who had valves replaced with the Direct Flow device, 82 percent remained alive after one year, according to results released last week.

Those results are consistent with trials conducted before Direct Flow received permission to market its valve in Europe in 2013, the company said.

“We have a product that’s very viable,” Lemaitre said. Its advantage is the ability of physicians to position the new valve “exquisitely” in the heart in order to prevent leakage of blood flowing back the wrong direction.

“We can make the valve dance like a puppet, like a marionette,” Lemaitre said. “We can get it in just the right place.”

Lemaitre became CEO of the 11-year-old company in May. It has 250 workers, including about 140 in Santa Rosa.

The former CEO, Bernard Lyons, retired after nine years leading Direct Flow.

Less invasive procedures to replace the aortic valve, one of four heart valves, have been in use since 2007. Physicians deliver the new valves to the heart via catheters, typically through the femoral artery near the groin.

Aortic heart valve replacement is considered a billion dollar market with even greater potential if the procedures eventually are proved a safe alternative to open-heart surgery for most patients.

Such companies as Medtronic and Edwards Life Science already have received U.S. approval for their devices.

Direct Flow’s device has been implanted in nearly 2,000 patients in Europe, where the company now has a 5 percent share of the market, Lemaitre said. He suggested that was noteworthy because the company’s system is now available at only 15 percent of the medical centers there that perform such procedures.

Along with its efforts in Europe, the company is working to obtain FDA approval for use in the United States. Direct Flow already has conducted preliminary studies and next hopes to enroll about 900 patients in a randomized study that would compare the results of implants using the Direct Flow device and other commercially available devices.

The aim is to complete the procedures next year and to submit data to federal regulators by late 2017, Lemaitre said.

Lemaitre previously served as CEO in 2008-2009 for CoreValve, an aortic heart valve company that was acquired by Medtronic in a deal worth $800 million.