Eclipse Surgical Technologies, a medical device company specializing in cardiac angiogenesis, announced today that promising data from a randomized
double-blinded independent assessment study of the company's minimally-invasive laser heart procedure, Percutaneous Transmyocardial Revascularization (PTMR), for treating advanced cardiovascular disease is being presented at the annual American College of Cardiology (ACC) conference
in Orlando, Fla. March 18-21.
The BELIEF (Blinded Evaluation of Laser PTMR Intervention Electively For
angina pectoris) study, conducted by Dr. Jan Erik Nordrehaug, who chairs the
Department of Heart Disease at University Hospital of Bergen, Norway and is a
member of the advisory committee of the Norwegian Ministry of Health, showed
by independent assessment that patients who underwent the innovative
catheter-based procedure were at least three times more likely to experience
substantial relief from crippling chest pain called angina than those who
received a sham procedure. The preliminary results of the randomized,
double-blinded study measured and compared the reductions in chest pain
between the two groups after six months.
Dr. Nordrehaug is attending the ACC conference and he presented the
preliminary results from the BELIEF study yesterday, the first of three
sessions focused on the study being presented during the conference.
"This is truly a pioneering study, carried out under strict scientific
criteria," Dr. Nordrehaug said. "The BELIEF study using the Eclipse Axcis(TM)
PTMR system was designed to isolate the 'placebo effect' component of
functional benefit previously reported in PTMR and TMR publications. We were
able to perform the PTMR procedure so that both the patient and physician were
blinded as to whether or not laser energy was actually delivered."
Dr. Nordrehaug added that "the results of the BELIEF study convinced me
that this procedure does indeed relieve angina and eliminates concern that
'placebo effect' is a primary source of persistent symptomatic relief. My
patients treated with the laser showed significant improvement, which, I
believe, is great news for the thousands of people around the world who suffer
from this debilitating pain."
Dr. Nordrehaug presented his data at 2:45 p.m. Sunday, March 18.
Highlights of his study will also be presented at 2:45 p.m. today, March 19
and at a breakfast meeting at 6:30 a.m. Wednesday, March 21 at the Embassy
Suites International Drive Seminole Room.
In PTMR, which has not yet been cleared by the US Food and Drug
Administration (FDA), a cardiologist positions an aligning catheter into the
femoral artery and uses an Eclipse laser to create tiny channels in the heart
muscle that are believed to stimulate the growth of new blood vessels
(angiogenesis). PTMR is related to an FDA-cleared surgical procedure done
with the Eclipse laser called TMR (Transmyocardial Revascularization).
The BELIEF study is the first double-blinded study of Eclipse's PTMR
procedure. The Company had previously conducted a multi-center, prospective,
randomized study that was the basis for the Company's PMA submission to the
FDA in December 1999 seeking clearance to market PTMR.