Dow Jones Newswires | An Abbott Laboratories device designed to
clip together leaky heart valves without major surgery showed similar
performance among patients with different causes of valve problems in
new study data, Abbott said Tuesday.

The company said these results suggest the MitraClip, sold in Europe and
under review by the Food and Drug Administration, could benefit a broad
swath of patients. Other data from the company-funded “Everest II”
study showed that clip and traditional surgery patients didn’t see any
difference in the need for additional surgery at two years.

These data were set for presentation Tuesday at the EuroPCR cardiology conference in Paris.

Abbott’s device is threaded through blood vessels to the heart, where it works like a clothes pin to hold together parts of faulty mitral valves, presenting a potential alternative to more invasive surgery. Sales are slight, but less-invasive valve procedures are a closely watched, emerging market for device makers, and Abbott has estimated the MitraClip could grow in coming years to several hundred million dollars in annual sales.

The Everest II study includes 279 patients. In results unveiled in March, MitraClip posted much better one-month safety results than regular chest-opening surgery, since surgery was more likely to require transfusions.

The device didn’t reduce the valve leakage problem as much at one year, raising some questions among doctors. But the study also suggested patients could try clip treatment without big risks while maintaining the option for surgery later.

The issue at hand, known as mitral regurgitation, affects more than 8 million people in the U.S. and Europe, Abbott estimated. It often isn’t surgically repaired because patients are too sick or frail.

Abbott, which would like to reach a broad patient group, said the latest cut of one-year data showed similar results for the two main types of mitral regurgitation. Most patients with the issue have it due to heart-muscle abnormalities — often from other heart issues — while a smaller group have a degenerative valve problem.

The rate of major adverse heart events was very similar for both groups at 30 days, and far below the rate seen among traditional surgery patients, Abbott said. And at one year, patients with both types of valve issues showed improvements in heart function, reduced symptoms and improved quality of life, the company said.

Meantime, among 86 patients in the study evaluated through two years and considered at risk for needing more surgery, there was no difference in the need for added surgery among patients treated first with the clip or regular surgery. That shows a “durability of outcome,” said John Capek, Abbott’s vice president for medical devices, in an interview.