CARDIOGENESIS RECEIVES FDA APPROVAL TO START
MULTI-CENTER PERCUTANEOUS,
Myocardial Revascularization Clinical Trial
SUNNYVALE, Calif., July 15 /PRNewswire/ -- CardioGenesis Corporation
(Nasdaq: CGCP), a leader in transmyocardial revascularization (TMR)
technology, announced today it has received approval from the U.S. Food
and Drug Administration (FDA) to begin the multi-center clinical trial
of its proprietary Percutaneous Transmyocardial Revascularization
(PMR(TM)) System to treat angina in no-option patients at up to ten
clinical sites. No-option patients experience debilitating chest pain
(angina), resulting from severe coronary artery disease, and are not
candidates for conventional therapies.
The proprietary CardioGenesis PMR System is designed to be used in a
minimally invasive procedure by an interventional cardiologist in a
cardiac catheterization laboratory in contrast to intraoperative TMR
procedures performed by surgeons in an operating room. The patient
remains conscious during the procedure and the beating heart is
accessed via a small puncture in the upper thigh, through which a
CardioGenesis PMR catheter system is placed into the femoral artery,
passed across the aortic valve, and positioned within the left
ventricle. Laser energy, synchronized to the patient ECG to minimize
the risk of irregular heart beats, is delivered through the fiber-optic
equipped catheter to create channels from the inside of the heart part
way through the diseased area of the left ventricle. The System is
engineered to provide a high level of safety, control, stability, and
freedom of movement in the left ventricle for accomplishing the
procedure. The objective of the PMR procedure is to provide a therapy
which significantly decreases chest pain and improves the functional
capacity for no-option patients.
"We are very pleased with the FDA's approval to start the U.S. clinical
trial of our PMR System," said Allen W. Hill, CardioGenesis' president
and chief executive officer. "We believe the FDA approval of our
request to move to the multicenter trial furthers our leadership
opportunity in the field of TMR. A pilot PMR study, conducted in
Europe over the past six months, provided the safety data and a
regulatory pathway for us to take this course with the clinical trial."
The Company originally expected to initiate patient enrollment in the
second quarter of 1997.
No-option patients with Class III or Class IV angina are candidates for
the PMR trial. The Company is authorized to conduct the trial at up to
ten cardiovascular treatment centers in the United States. The sites
have been selected and training and orientation is underway.
Since last November, when CardioGenesis first treated humans in Europe
with its PMR System, over twenty no-option patients have been
treated. "Although we have limited clinical results, we are pleased
with the early safety and efficacy performance, of the PMR System. The
data are tracking the preliminary results seen in the ITMR pilot study
and no deaths have been reported," Hill said. Total procedure time has
been brief, averaging approximately 50 minutes for experienced
interventional cardiologists. Time to create ten or more channels
averages less than 15 minutes. The majority of patients have been
discharged from the hospital in two to three days. Patients continue to
be enrolled into the European pilot study.
CardioGenesis Corporation, based in Sunnyvale, California, develops,
manufactures, and markets proprietary disposable products to perform
intraoperative transmyocardial revascularization (ITMR), catheter-based
percutancous myocardial revascularization (PMR), and thoracoscopic
transmyocardial revascularization (TTMR(TM)) to treat patients
afflicted with debilitating angina. These probes and catheter systems
deliver laser energy to create channels in the oxygen-deprived
(ischemic) regions of the heart muscle (myocardium).
NOTE: Except for the historical information contained herein, the
matters discussed in this news release are forward-looking statements |
