* HeartWare investigator defends research
* HeartWare shares hold near record after big rally
* Rival Thoratec shares remain depressed
By Debra Sherman
CHICAGO, Nov 18 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
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
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
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