Menlo Park company is in the last stages of clinical trials for a device that could ultimately reduce the need for open heart surgery

The introduction of stents has drastically reduced the number of bypass surgeries in the United States, and a new device about to hit the market is expected to do the same for open heart surgery.

Medical device company Evalve Inc. in Menlo Park is in the final stages of clinical trials for its device called "MitraClip" that can repair mitral regurgitation, a weakness in heart valves.

When blood is pumped through the valves into the next chamber, the valve closes to prevent any blood from flowing backward. When the valve is damaged due to heart attacks, or aging, the valve doesn't close properly, allowing blood to flow backward. When the blood doesn't flow through the heart appropriately, the patient can suffer from fatigue, shortness of breath and ultimately congestive heart failure.

An estimated 4 million people in the United States have significant mitral valve insufficiency, with an annual incidence of 250,000, according to officials at Evalve. More than 50,000 people each year have open heart surgery to repair the valves, a medical procedure that requires the chest cavity to be opened and the heart stopped during the surgery. This is a high-risk procedure with a long recovery time.

Evalve has developed a clip that can be inserted with a catheter through the femoral vein at the groin. Once the physician reaches the heart with the clip, the loose ends of the valve are clipped together, therefore reducing the back flow of blood.

"This is one of the most exciting developments in interventional cardiology in decades," said Dr. Jason Rogers, director of cardiovascular research at University of California Davis Medical Center. "This represents a whole new approach to treating valve disease."

UC Davis has 10 patients in the trial. "Because it's less invasive, it will allow a lot of patients to get treatment who can't be treated because they aren't healthy enough to undergo surgery," Rogers said.

In December, Evalve secured $60 million in Series D Financing from a variety of venture capitalists to help fund the commercialization of MitraClip in Europe and continue moving forward for approval in the United States. The study started in 2005 to recruit 279 patients from 38 sites across the county, including UC Davis in Northern California.

"What we've been seeing is that patients are going home within one or two days after the procedure," said Ferolyn Powell, president and CEO of Evalve. The recovery time is much less when compared with open heart surgery that carries a lot more risk, and can keep a patient in the hospital for a week or longer.

The procedure is done in the hospital catherization lab while the patient is asleep. The cardiologist can make the repairs while the heart is beating, therefore eliminating the need to stop the heart like in traditional open heart surgery.

Physicians are able to immediately see if the MitraClip works, if not, then they keep trying to place the clip on the valve in the right spot that will reduce the leakage the most.

"There's only about 10 percent of cases they don't leave the clip because it doesn't sufficiently reduce the backflow," Powell said.

It the clip doesn't work, nothing is lost. The patient can still have open heart surgery to repair the problem.

In October 2007, the company released a study on patients three years after the procedure.

Here are a few highlights of the 36 month follow-up:

• 82 percent of patients who had a successful result with the MitraClip device remain free from surgery 36 months after the procedure.
• 12 months after a successful MitraClip procedure, significant reverse remodeling of the left ventricle was demonstrated. Reverse remodeling was assessed based on five echocardiographic measures, including left ventricular end-systolic dimension.

"Our work to reduce mitral regurgitation with a percutaneous approach continues to produce compelling results," said Ted Feldman, M.D., who presented the 36 month follow-up data at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C. in October. Feldman is a national co-principal investigator and director of the cardiac catheterization lab at Evanston Northwestern Healthcare in Evanston, Illinois.

"The reduction in MR ( mitral regurgitation) severity, along with the stability of the results at 36 months and the preservation of subsequent surgical options, leads us to believe that the MitraClip device is likely to become a viable first-line option for treating MR in many patients," Feldman said.

More than 300 MitraClip devices have been implanted in patients. Pending the United States Food and Drug Administration approval, the device could be on the market within two years.

"This is extremely promising," said Rogers. "The preliminary data looks very good. No technology is perfect, and this is the first of its kind in the world. But the results are outstanding."

The clip isn't for everyone. Some patients' valves are damaged to the point a clip wouldn't work, said Rogers.

—By Troy May

Troy May is the executive editor of the Healthcare Journal. You can reach him at tmay@healthcarejournalnorcal.com.