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Direct Flow Medical is taking the next step in its attempt to show it has a better system for replacing heart valves without surgery.

The Santa Rosa company, which is competing with such medical device giants as Medtronic and Edwards Lifesciences, this month began a U.S. trial for its transcatheter aortic heart valve system. Earlier this year, the device was approved for use in Europe.

The competing systems currently are restricted to patients deemed too ill or frail for open heart surgery. The survival of these patients, many of whom are in their 80s, often depends on obtaining a new valve to control blood flow to the aorta, the main artery in the body.

Analysts estimate that the worldwide market just to serve these patients could amount to billions of dollars. Moreover, some experts foresee a time when the developing technology could become the predominant way of replacing aortic valves.

"It's new but it's incredibly promising," said Dr. William O'Neill, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.

O'Neill performed the first aortic valve replacement by catheter in the U.S. in 2005, and this month implanted the first Direct Flow valve in a U.S. patient involved in the new trial. He predicted that in a decade fewer aortic valves will be surgically replaced and that eventually "the vast majority are going to be done by these less-invasive techniques."

Direct Flow may seem a small player in this burgeoning market. The nine-year-old company has 130 employees in Santa Rosa and Lake Forest and has received $75 million in venture capital. Since it received European approval, its device has been implanted in just 130 patients there.

But its chief executive expressed confidence that what matters isn't company size but who has the most innovative product.

"Physicians want to provide their patients with the best outcomes," said Direct Flow President and CEO Bernie Lyons.

A key distinction that Lyons touts is the low rate of patients who suffer blood leakage from his company's valve. Such leakage, known as regurgitation, has been identified by physicians and analysts as a key concern in the replacement valve procedures because it appears linked to higher rates of patient deaths.

An estimated 350,000 elderly Americans suffer from severe aortic stenosis, said Jason Mills, a managing director in San Francisco with Canaccord Genuity investment bank. The diagnosis refers to a stiffening of the heart valve leaflets, reducing their ability to fully open and close.

The resulting restriction of blood flow to the aorta causes the heart to pump harder and can result in such symptoms as chest pains, fatigue and shortness of breath.

"Without treatment, half of the people feeling symptoms die within an average of two years," according to the Edwards Lifesciences website.

For many, relief comes by replacing the valve in open heart surgery -- deemed a proven and reliable procedure but also one that requires sawing open the chest and stopping the heart. In the last decade physicians have begun to experiment with less invasive techniques for those deemed too risky for surgery.

Direct Flow exists as part of a sizable group of Sonoma County medical device companies, including TriVascular and Medtronic's Santa Rosa-based vascular business. Lyons said the county ranks as the fourth-largest concentration of such businesses in the nation.

Direct Flow's valves are roughly the size of a quarter and made of bovine tissue.

The device is collapsed to the diameter of a pencil and delivered on the tip of a catheter, a thin tube inserted into a patient's artery. It is snaked through the artery to the heart, where it is expanded in place of the old valve.

For its European trial, Direct Flow conducted valve replacements in 100 patients. It's new U.S. trial will involve

— 30 patients at six U.S. sites.

Both Direct Flow and Minneapolis-based Medtronic separately are seeking FDA approval for their devices in the domestic market. Medtronic hopes to do so by next year, a company spokeswoman said. Direct Flow is aiming for early 2017, Lyons said.

Some Medtronic staff at the Santa Rosa facility help produce portions of the aortic valve system. The company reports that its valves have been implanted in more than 45,000 patients outside the U.S.

In 2011, Irvine-based Edwards Lifesciences became the first company approved in the U.S. for sale of a less-invasive valve replacement system. Edwards reported that its aortic valve devices boosted overall domestic sales by nearly $204 million last year.

Mills, the analyst with Canaccord Genuity, estimated the potential U.S. sales for such devices could jump to more than $700 million by 2015 and to more than $1.5 billion by 2017.

"It's early days for the company," Mills said, but Direct Flow's initial studies have produced "outstanding data" in regard to the lack of leakage around the valve. If further studies continue to demonstrate strong results, he said, "it could mean very good things for Direct Flow Medical."

As with Direct Medical, both Edwards and Medtronic this year have reported on the advances and benefits of their valve replacement systems.

In May, Medtronic released results of a study with year-long results of nearly 1,000 patients around the world. Researchers concluded that the data showed low rates of mortality and stroke.

Nonetheless, medical experts have maintained in journals and other writings that several critical issues must be addressed before the procedures can be expanded to a wider group of patients. A common concern is leakage around the valve.

"That leaking was important because it seemed to impact on the survivability of the patients," said Dr. Charles Davidson, Direct Flow's chief medical officer and the clinical chief of cardiology at Northwestern University's Feinberg School of Medicine.

In results from its European trial, Direct Flow reported that only 1 percent of patients showed "moderate" leakage after 30 days, while 26 percent experienced "mild" leakage and 73 percent showed a trace or none.

Davidson said the results, while short-term, approach those found in surgical valve replacements.

Along with leakage, increased risk of strokes remains a concern.

To address that risk, one approach is to try to prevent anything knocked loose during valve replacement from reaching the brain. A local company, Santa Rosa-based Claret Medical, has developed a catheter system to do just that by filtering and catching mineral deposits and other debris released into the blood during the procedure.

Still another difficulty, especially in some smaller patients, is safely threading the catheters through the arteries.

Direct Medical said its system has a lower profile for easier passage. The device also has a unique capability to be repositioned or even retrieved by physicians during implantation.

Edwards this year also announced improved outcomes from a new valve system with a lower profile.

Experts agreed that it's one thing to use the current procedures in patients unable to benefit from open heart surgery. But in order to expand the procedure to relatively healthier patients, the device manufacturers will need to show that they have mitigated the current risks and can provide long-term benefits through the less-invasive techniques.

Gathering such data will take years.

"You've got to have comparable results to (those of) the surgeon," Lyons said.

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

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