To: pete who wrote (177 ) 4/26/1998 8:31:00 PM From: Charger Respond to of 410
Am involved with PLC, they were mentioned on CNBC Friday nite, and so am looking around at medical stocks. What is "vascular engineering". Is it anything to do with this? FDA Advisory Panel Unanimously Recommends Approval Of PLC Systems' Heart Laser System For TMR FRANKLIN, Mass., April 24 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC - news) today announced that an FDA Advisory Panel unanimously recommended that The Heart Laser(TM) System for transmyocardial revascularization (TMR) be approved for marketing for patients who suffer from severe, stable angina and are not amenable to conventional coronary revascularization techniques (e.g., bypass surgery and angioplasty). As part of its recommendation, the Panel described certain labeling conditions and post-market surveillance obligations for FDA's consideration. ''We are extremely pleased by the Panel's recommendation for approval,'' said William C. Dow, president and CEO of PLC Systems Inc. ''TMR with The Heart Laser System has helped more than 70 percent of patients enrolled in the study improve the quality of their lives. The Panel's request for a post- market surveillance study was not unexpected. It makes sense clinically and commercially. ''Our data, including the 12-month data, addressed the Panel member's questions, and provided them reasonable assurance that The Heart Laser System is safe and effective, as well as a basis to make this favorable recommendation. Although we know the Panel's decision is not binding, we enthusiastically look forward to the FDA's final action on our application. We believe TMR with The Heart Laser System will enable us to provide a much needed alternative for the many thousands of heart disease patients who have run out of options,'' he added. TMR with The Heart Laser System is a new surgical procedure for patients with chronic, severe coronary artery disease with no treatment alternative. The procedure has been performed on approximately 3,500 patients worldwide. Since TMR with The Heart Laser System is minimally invasive, recovery is generally quicker and less traumatic than open procedures. Generally no blood transfusion is needed and, because the procedure is performed on a beating heart, there is no need for a heart-lung machine. PLC Systems Inc. is a cardiac revascularization company that is pioneering, developing and supplying the systems and components for TMR. The company is investigating TMR as a technology with the potential to provide patients suffering from coronary artery disease an adjunct to angioplasty and coronary bypass graft surgery. PLC Medical Systems, Inc., a wholly-owned subsidiary of PLC Systems Inc., has developed The Heart Laser System for TMR, which uses PLC's patented ''heart-synchronized pulsed laser'' technology for TMR. NOTE: Certain of the above statements may be 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 factors, including competitive developments, regulatory approval requirements, the ability to convince healthcare professionals and third-party payors of the medical and economic benefits of The Heart Laser System, and the risk factors described in the company's annual report, SEC Form 10K for the fiscal year ended December 31, 1997, and the company's other SEC reports. This is a surgery technique for hearts which has just been approved. See the PLC thread. What is AVEI all about? And why is it falling?