CO2 TMR Heart Laser Demonstrates Long-Term Angina Relief for Cardiac Patients

Cardiac patients who have received carbon dioxide (CO2) Transmyocardial Revascularization (TMR) using PLC Systems’ Heart Laser are experiencing excellent long-term clinical benefits. The angina relief benefits are sustained for five years and beyond after the CO2 revascularization therapy. Today, data from a multi-center, long-term study on the efficacy of CO2 revascularization was published in Circulation, the official journal of the American Heart Association. PLC Systems Inc. (Amex: PLC) developed the CO2 TMR Heart Laser.

“Angina relief from CO2 revascularization continues for five years and beyond,” said Dr. Keith Horvath, lead author of the study and Assistant Professor of Surgery at Northwestern University Medical Center. “The CO2 Heart Laser is the only TMR laser to demonstrate effective, sustained, long-term angina relief to severely debilitated heart patients. Additional studies have demonstrated that the CO2 revascularization therapy promotes an angiogenic response, which is the foundation for the long-term clinical benefits. These results are directly attributable to the favorable interaction between the CO2 laser and the tissue of the heart.”

“Publishing the five-year angina relief data represents a clinical milestone,” stated PLC Systems’ CEO and President Mark R. Tauscher. “PLC’s CO2 revascularization therapy is the first and only TMR laser therapy to report and publish long-term angina relief results. We believe the long-term therapeutic benefits of CO2 revascularization exclusively positions this TMR therapy as a standard of care for heart patients. PLC’s CO2 revascularization approach has improved the quality of life for thousands of patients suffering from debilitating angina; these long-term results confirm our belief that the CO2 Heart Laser provides a superior technology for TMR.”

Five-Year Angina Relief Data Show Prolonged Benefits

The first multi-center, long-term study on the efficacy of TMR with a CO2 Heart Laser has demonstrated that the procedure provides significant long-term angina relief beyond five years.

Angina classifications, which are measured in classes ranging I to IV (IV being the most painful), were prospectively collected from eight clinical sites, which included 78 patients up to seven years after TMR. Their median age was 61 years at the time of treatment. Preoperatively, 66 percent had unstable angina, 73 percent had suffered at least one myocardial infarction, 93 percent had undergone at least one coronary artery bypass graft, 42 percent had at least one angioplasty, 74 percent were in angina class IV and 26 percent were in class III. Patients’ average pre-TMR angina class was 3.7.

One year after CO2 TMR, the average angina class was recorded at 1.5. At 4.6 years, the average angina class remained virtually unchanged at 1.6. Seventeen percent of the patients had no angina after five years and 64 percent were in class I or II. A decrease of at least two angina classes was considered significant. By this criterion, 68 percent of the patients had successful long-term angina relief.

PLC Systems Inc. is a medical device company specializing in manufacturing, marketing and selling carbon dioxide (CO2) lasers to treat coronary artery disease. Earlier this year, PLC announced a strategic marketing alliance and exclusive United States distribution agreement with Edwards Lifesciences Corporation (NYSE: EW) for PLC’s CO2 TMR laser technology. PLC, along with Edwards, markets and distributes its patented CO2 Heart Lasers, which a cardiac surgeon would utilize to perform transmyocardial revascularization (TMR).

The CO2 TMR therapy is a surgical procedure that relieves chest pain in severely debilitated heart patients. The CO2 Heart Laser is the only TMR laser that has reported and published long-term angina relief results. A cardiac surgeon utilizes the laser to create approximately 20 to 40 channels to allow oxygen-rich blood to reach previously deprived areas of the patient’s heart. To date, more than 7,500 patients have been treated with a CO2 TMR Heart Laser.

For more information on PLC and its products, please visit the Company’s Web site at www.plcmed.com.

Note: Certain of the above statements are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including operational changes, competitive developments, regulatory approval requirements, the ability to convince health care professionals and third party payers of the medical and economic benefits of The Heart Laser System, no assurance that all payers will reimburse health care providers who perform TMR procedures or that reimbursement, if provided, will be adequate, and risk factors described in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and the company’s other SEC reports.