CardioGenesis Announces Preliminary Results of Feasibility
Study for PMR(TM) System in 'No Option' Patients
SUNNYVALE, Calif., Sept. 4 /PRNewswire/ -- CardioGenesis Corporation (Nasdaq:CGCP), a leader in transmyocardial revascularization (TMR) technology, announced the preliminary results of a 21-patient feasibility study conducted in Europe of its Percutaneous Myocardial
Revascularization (PMR(TM)) System. Preliminary results from six of these patients reporting at three and six months demonstrated a drop in angina pain class, from an average of 3.0 prior to therapy to an average of 1.5 at most recent visit. Angina pain is classified on a four-point scale, with Class IV being the most severely debilitating angina. An increase in exercise tolerance was also recorded for patients after treatment with the CardioGenesis PMR System. The PMR
System is being studied by CardioGenesis for the possibility of its use in ``no option'' patients with severe coronary artery disease who are not candidates for conventional therapies, including coronary artery bypass graft surgery (CABG) or percutaneous balloon angioplasty
(PTCA).
``We are pleased with these preliminary findings pertaining to our PMR System,'' said Allen W. Hill, CardioGenesis' president and chief executive officer. ``The results provide the information and insights needed to move our PMR clinical and regulatory programs forward.
Reported reduction in angina pain score and improvement in exercise tolerance are comparable to results we have seen with studies using our Intraoperative Transmyocardial Revascularization System (ITMR(TM)) and all patients in the feasibility study of our PMR System so far are doing well,'' said Hill.
The results of the feasibility study were presented last week at a CardioGenesis-sponsored symposium during the Congress of the European Society of Cardiology held in Stockholm, Sweden.
CardioGenesis was the first company in the world to use a minimally invasive percutaneous approach to TMR in ``no option'' patients. In July 1997, CardioGenesis received approval from the FDA to start a multi-center clinical trial of its proprietary PMR System to treat ``no option'' patients at up to 10 clinical sites in the United States. CardioGenesis treated its first patient at Stanford University Medical Center on July 31, 1997 under the FDA approved protocol.
The PMR System is designed to be used by an interventional cardiologist in a cardiac catheterization laboratory, in contrast to intraoperative TMR procedures performed by surgeons in an operating room. During the PMR System procedure the patient remains conscious.
There is no surgical incision. The beating heart is accessed via a small puncture in the upper thigh through which a cardioGenesis-proprietary guiding and steering 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's ECG to minimize the risk of damage resulting from
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 PMR 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, without the risk and costs associated with a major surgical procedure.
CardioGenesis Corporation, based in Sunnyvale California, develops, manufactures and markets proprietary systems, including disposable products, to perform intraoperative transmyocardial revascularization (ITMR(TM)), catheter-based percutaneous myocardial revascularization
(PMR(TM)), 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).
CardioGenesis holds patents for the system and method of percutaneous myocardial revascularization, U. S. Patent Number 5,389,096; the method for intraoperative myocardial device revascularization, U.S. Patent Number 5,380,316; and other patents in the field of
transmyocardial revascularization. For additional information on the company and their products, visit the CardioGenesis website at www.cardiogenesis.com.
NOTE: Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risk and uncertainties, including reliance on Boston Scientific Corporation as the exclusive distributor outside the U.S. for the company's products, effect of possible pricing changes, the impact of indirect sales on operating results, the timely availability and acceptance of new products, the impact of competitive products and pricing, approval for and final results of clinical studies, timing of
regulatory approvals, potential third-party patent infringement claims, the management of growth and the effectiveness of ITMR, TTMR and PMR. For further information, refer to risk factors under the caption ``Management's Discussion and Analysis of Financial Condition and Results of Operations - Risk Factors'' and elsewhere in the Company's 1996 Form 10-K as filed with the Securities and Exchange Commission.
For more information on CardioGenesis Corporation via fax, dial 800-PRO-INFO, code CGCP. |
