HeartWare International Inc. (HIN) rose the most in more than a year after its implantable pump for heart-transplant candidates gained support from U.S. regulatory advisers who said the device provides dying patients a lifeline.
HeartWare jumped 12 percent to $77.52 at the close of trading, the most since Nov. 15, 2010. A Food and Drug Administration panel of academics and physicians voted 9-2 that the benefits outweigh the product’s risks at a meeting yesterday in Gaithersburg, Maryland.
The U.S. market for left ventricular pumps may pass $750 million in 2015, said Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco. If HeartWare’s system also is approved for patients who aren’t eligible for a transplant, the Framingham, Massachusetts-based company may split the U.S. market with Thoratec Corp.’s HeartMate II by 2015, Mills said by telephone before yesterday’s vote.
“We believe the FDA is likely to approve the device because the agency usually follows the panel’s advice and we believe FDA is interested in there being an alternative” to the Thoratec product, analyst Larry Biegelsen with Wells Fargo Securities in New York wrote in a note to clients.
Take Over Heart
The HeartWare and Thoratec devices are intended to take over for a failing heart, extending patients’ lives or gaining time to find a transplant donor. FDA staff said in an April 23 report they were concerned about stroke rates and missing data for 80 percent of patients that tested the HeartWare system.
“Lack of data really means nothing to a patient that is dying, and this pump is a good alternative,” said Joseph Amato, a panel member and a doctor at Rush University Medical Center in Chicago.
The panel also voted 8-3 that the pump is safe and 11-0 that it’s effective. The FDA isn’t required to follow the group’s recommendations.
Heart failure is a progressive disease that strikes 1 in 5 Americans older than 40. It occurs when a damaged organ can’t supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments and no cure.
Fifteen patients on the HeartWare device experienced strokes about six months into testing, according to the staff report. This data “suggest a trend toward higher stroke rates” with the pump compared to other devices, the staff wrote.
Stroke Rate ‘Acceptable’
“The stroke rate given the alternative these patients are facing, which is certain or imminent death, I think it’s acceptable,” David Slotwiner, with the Long Island Jewish Medical Center and a panel member, said during the meeting.
Thoratec dominates the worldwide ventricular assist device market with about 68 percent of the market share, according to data compiled by a Bloomberg analyst, Michael Manns. The Pleasanton, California-based company’s HeartMate had $366 million (THOR:US) in revenue last year.
HeartWare’s device is sold in Europe. It’s implanted next to the heart, avoiding the abdominal surgery required by competing devices, the company said. Thoratec’s HeartMate II is placed below the diaphragm in the abdomen. HeartMate II is approved for heart-failure patients whether they are eligible for transplantation.
HeartWare is recruiting patients for a study on the device’s use in patients who aren’t eligible for heart transplant, according to the National Institutes of Health website clinicaltrials.gov.
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