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HeartWare defends heart pump study against Thoratec
November 18, 2010 / 8:32 PM / 7 years ago

HeartWare defends heart pump study against Thoratec

* HeartWare investigator defends research

* HeartWare shares hold near record after big rally

* Rival Thoratec shares remain depressed

By Debra Sherman

CHICAGO, Nov 18 (Reuters) - A rivalry between HeartWare Inc HTWR.O and Thoratec Corp THOR.O erupted into a high-stakes battle this week at the world’s biggest annual cardiology meeting, where the medical device makers argued over research showing an advantage to HeartWare’s implantable heart pump.

HeartWare released a study at the American Heart Association meeting on Sunday, showing that 92 percent of patients survived with the HeartWare device or received a heart transplant after 180 days. [ID:nN14200498]

The study also suggested that one of the biggest side effects of heart pumps, gastrointestinal bleeding, was considerably less with HeartWare’s device than with Thoratec’s pumps.

Use of the HeartWare device also resulted in fewer infections, the other big problem with such devices, than reported in Thoratec’s earlier clinical trial.

Shares of HeartWare surged more than 20 percent to record levels on the data as investors saw the study boosting its chances for U.S. approval for the device, while Thoratec stock lost 20 percent of its value. [ID:nSGE6AE0ZI]

Thoratec fought back on Tuesday, when its Chief Executive Gary Burbach held a lunch with analysts and said that HeartWare’s researchers did not make fair comparisons and that the study’s results were skewed.

Dr. Keith Aaronson, a cardiologist at the University of Michigan Medical Center, was lead investigator of the HeartWare study, showing how its pump -- known as a left ventricular assist device -- worked in advanced heart failure patients who were waiting for a transplant.

He defended the study’s findings in an interview with Reuters, saying that while it was not a head-to-head comparison of the two devices, he used comparable clinical data from other published studies to draw conclusions.

“I don’t want to get into a pissing match with (Thoratec CEO) Gary Burbach,” Aaronson said. “I don’t have any financial conflicts. I haven’t taken a penny. We used the best comparisons we had and we will find out what’s best. Time will tell. It usually does.”

According to analysts who attended the meeting on Tuesday, Thoratec’s Burbach suggested the survival data on the two competing devices were comparable. He cited different enrollment time periods, suggesting the patients in the HeartWare study enrolled more recently and benefited from doctors having more experience with the device.

Burbach also said patients were less sick, and he disputed the more favorable outcomes on bleeding with the HeartWare device.

Thoratec declined to comment.

Aaronson acknowledged that the HeartWare study included patients who were not as sick as those in earlier studies and that clinicians have more experience today, which always helps results. However, he stood behind the conclusion that there was less bleeding using the HeartWare device.

“There’s no question that the best (study) is one where you have a clinical trial that makes direct comparisons -- that’s the gold standard. Short of that, any conclusions you draw are speculative,” Aaronson said.

“But we as doctors are obligated to take the available evidence we have and let people reflect on it and make their best judgment. We used the best data we had to do that.” (Reporting by Debra Sherman; Editing by Michele Gershberg and Steve Orlofsky)

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