HeartWare International Inc.’s implantable pump for heart-transplant candidates won the backing of U.S. advisory panel members who said the device would provide dying patients a lifeline.
The 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 FDA isn’t required to follow the group’s recommendations.
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 the HeartWare Ventricular Assist 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 in a telephone interview before the vote.
The HeartWare and Thoratec devices are intended to take over for a failing heart, extending patients’ lives or gaining time to find a donor for transplant. FDA staff said in an April 23 report that 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.
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.
HeartWare was supposed to collect central venous pressure or right atrial pressure of patients using the company’s device and of those in a registry who were considered the control group. The company gathered the data for 51 percent of patients and for the rest replaced the missing value with the treatment group median, the FDA staff said.
While panel members said they wanted to have the data, it likely isn’t a “fatal flaw” in the study, Richard Page, chairman of the panel, said during the meeting. Page is with the University of Wisconsin School of Medicine and Public Health.
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.
“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 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.