CHICAGO (Reuters) - HeartWare International Inc’s implantable device heart pump used in patients with advanced heart failure who were awaiting a heart transplant, met its goal in a major study.
The data, presented at the annual meeting of the American Heart Association in Chicago this week, showed that 92 percent of patients whose hearts were too weak to sufficiently pump blood, survived with the pump or received a heart transplant after 180 days, meeting its main goal.
Nearly one year after implantation of the device -- about the size of a golf ball and weighing about 5 ounces -- 91 percent had survived, compared with 86 percent in the control group, a difference that was not considered statistically significant.
Results of the study of 140 patients at 30 U.S. medical centers were comparable to other pumps that already are approved as a bridge to transplant.
The HeartWare left ventricular assist device, or HVAD as is known, already is approved in Europe.
Surgeons like the HVAD because it is smaller than other heart pumps and can be implanted in a pocket beneath the heart, rather than in the abdominal cavity. It is also a smaller operation that affords a shorter recovery period.
At a time when the wait for a donor heart is growing, this study brings the Framingham, Massachusetts, company one step closer to getting approval as a bridge to transplant in the United States, where Thoratec Corp dominates the market for heart pumps.
The results are “better than anything that’s been published, including Thoratec‘s, (data)” Dr. Keith Aaronson, lead investigator of the study, said in an interview.
But the clinical trial was not randomized -- the gold standard for medical research. Patients who received the HeartWare HVAD were compared with 499 comparable patients in a national registry who had received an earlier generation heart pump.
Patients were able to walk 371 feet farther in six minutes in the three months after getting the HVAD.
Aaronson noted that the two most dangerous side effects -- gastrointestinal bleeding and infection -- were less frequent with the HVAD, while stroke rates were about the same.
“I think what (doctors) will be excited about is the adverse event profile,” Aaronson said.
However, he noted that researchers did not directly compare complication rates in this study and that only a head-to-head study can confirm the validity of differences in complications.
A company spokesman said the study, sponsored by HeartWare, puts it on track to submit a premarket application to the U.S. Food and Drug Administration by the end of the year to be used as a bridge-to-transplant.
“While Street expectations were high coming into AHA, we believe that the consensus was for mid- to high-80s percent survival in the HVAD arm at six months. As a result, we expect the data to be viewed quite favorably by investors,” JP Morgan analyst Michael Weinstein wrote in a research note.
“We believe that this robust efficacy positions HeartWare well as it prepares for its U.S. launch next year and could accelerate the company’s already strong adoption in Europe,” he added.
HeartWare shares closed at $72.26 on the Nasdaq on Friday. They have traded between $76.19 and $30.90 during the past 52 weeks.
Reporting by Debra Sherman; Editing by Maureen Bavdek