Edwards Valve Inserted Straight Into Heart Has Improved Results in Study

Elderly patients getting Edwards Lifesciences Corp. (EW)’s Sapien heart valve implanted through the ribs as part of an expanded access program reaped more benefit than those observed in the initial trials, a study found.

After the original research, 822 more patients received the device that replaces a leaky aortic valve. Thirty days later, 8.2 percent of those patients died, compared with 8.7 percent in the initial trial. A year later, 23.6 percent of patients in the expanded program died, fewer than those who participated in the first study or who underwent standard open-heart surgery, Irvine, California-based Edwards said today in a statement.

Strokes were also lowest among patients who received the device after the original study, a result that should ease physician and investor concerns, said Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco. The research shows doctors are doing a better job selecting patients with damaged aortic valves who will benefit from Sapien and have improved their ability to implant them, he said in a telephone interview.

“The results exceeded our expectations by a considerable margin, in every category,” Mills said. “The stroke rate was the adverse event that everyone was focused on, with many investors worried it could provide a hurdle to approval. The stroke rate has declined markedly and directionally looks even better than surgical valve replacement.”

Stroke Data

The research, funded by the company and presented at The Society of Thoracic Surgeons’ annual meeting, found 2 percent of patients in the later group getting Sapien suffered a stroke within a month, compared with 7 percent in the initial study and 5.5 percent of those getting traditional surgery.

About 300,000 people in the U.S. suffer from severe aortic stenosis, which is a narrowing of the valve that typically develops with age. While surgery to replace the valve can ease the symptoms of breathlessness and weakness, many patients can’t withstand the procedure that requires cracking open the ribs.

While almost all of the patients had serious heart failure at the start of the expanded access program, most improved after treatment. Seventy-seven percent of the survivors had the mildest form of the condition, called class I or class II, a month after treatment with the surgery known as transapical valve replacement, up from 5 percent at the start of the study.

“We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery,” said Edwards Chief Executive Officer Michael Mussallem, in a statement.

Edwards won U.S. approval last year for the Sapien valve when inserted through the femoral artery for patients who aren’t candidates for open heart surgery. The company is waiting for Food and Drug Administration approval of the device for those at high-risk from standard surgery, which includes a transapical approach where the surgeon pierces the ribs and heart and puts it directly in place.

Edwards fell 1.2 percent to $78.27 at the close in New York. The company declined 5.9 percent in the past 12 months.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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