>>PLC SYSTEMS INC. Reports Financial Results For The First Quarter
Ended March 31, 1997<<
I did read it (I promised to watch this company), also read this one:
PLC Systems Announces Long Term Follow-Up Results of TMR Using The Heart Laser
April 30, 1997 10:37 AM EDT
Data Submitted in Preparation for Expected FDA Panel Advisory Meeting
Statistical Significance Reported in Myocardial Perfusion and Angina Relief
FRANKLIN, Mass., April 30 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC) today announced the long term results of its clinical studies evaluating Transmyocardial Revascularization (TMR) using the Company's high-powered C02 Heart Laser compared to medical therapy (the control group). This data has been submitted to the Food and Drug Administration (FDA) as a post-filing PreMarket Approval (PMA) submission in preparation for an expected FDA Advisory Panel meeting.
The effectiveness of the TMR treatment was assessed based on the changes observed in myocardial perfusion (blood flow into the heart muscle) and angina (chest pain).
Dr. Robert Rudko, Chairman of PLC Systems Inc., stated, "The clinical findings for TMR using The Heart Laser(TM) continue to be very impressive. Statistical significance has been demonstrated at 3, 6 and 12 months follow-up using thallium 201 testing and angina classification. We expect that the data collected will support a Food and Drug Administration approval for The Heart Laser sometime this summer."
One of the most objective indications of the success of the TMR procedure is through thalium 201 testing (nuclear perfusion studies) which measure myocardial perfusion, or blood flow into the heart muscle. The improvement in myocardial perfusion in the treated patients at 12 months post-op was statistically significant with a less than 0.1% probability of this improvement occurring by chance (p<0.001). Moreover, the change in myocardial perfusion observed between the treated group and the control group was also statistically significant. The reductions in angina observed in the TMR patients can be correlated with the statistically significant increases in myocardial perfusion.
"The evidence of increased myocardial perfusion is extremely important in supporting the potential effectiveness of the TMR procedure," continued Dr. Rudko. "The correlation between the reduction in angina and the increase in perfusion supports the theory that the clinical benefit demonstrated in these studies is the result of restored blood flow to the ischemic, or oxygen starved areas of the heart. To date, TMR using The Heart Laser is the only product to demonstrate increased myocardial perfusion in clinical testing."
Angina severity was measured using Canadian Cardiovascular Society 0 to 4 classification scheme. From a clinical standpoint, the angina severity is considered to have significantly changed when the change is a decrease of at least two classes.
At last available follow-up, approximately 70% of the 300 patients treated with TMR using The Heart Laser experienced a clinically significant decrease in angina post-op. In contrast, only 6% of the patients in the control group showed a clinical improvement in angina status. The difference in success rates between the two groups was highly significant with a less than 0.1% probability of this event occurring by chance (p<0.001).
Dr. Rudko concluded, "In addition to angina status, data was collected with respect to the event free survival of the two groups. An event was registered as death, heart attack or unstable/class IV angina. More than 70% of the treated group remained event free for the 12 months following the TMR procedure whereas, less than 10% of the patients in the control group remained event free over a 12 month period."
PLC Systems Inc. is a cardiac revascularization company developing medical systems and technology with the potential to provide patients suffering from coronary artery disease an alternative or adjunct to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc., a wholly-owned subsidiary of PLC System Inc., has developed the high-powered CO2 Heart Laser which uses the Company's patented technology for a new cardiosurgical procedure known as Transmyocardial Revascularization (TMR). To date, more than 2,500 patients worldwide have received TMR using The Heart Laser.
Note: Certain of the statements may be forward looking statements that involve risks and uncertainties. In such instances, actual results could differ materially as a result of a variety of factors including competitive developments, no guarantee of FDA approval and other risk factors listed from time to time in the Company's SEC reports. SOURCE PLC Systems Inc.
c PR Newswire. All rights reserved.
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