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Angina Pectoris/MI
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my personal edition > angina pectoris/mi > news

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DGNews
New Published Study Adds to Growing Body of Support for Transmyocardial Laser Revascularization Combined with Coronary Artery Bypass Surgery
FRANKLIN, MA -- July 9, 2002 -- PLC Systems Inc., the leader in carbon dioxide (CO2) Laser Revascularization technology used to treat patients with severe angina, or heart pain, today announced that a study published in the June 15, 2002 issue of the American Journal of Cardiology has confirmed previous safety and effectiveness results of Transmyocardial Revascularization (TMR).
"Relief from angina in patients treated with TMR continues to demonstrate excellent beneficial effects," said Dr. Steven Boyce, Director of Heart Transplant and Circulatory Assist Device Programs at The Washington Hospital Center. "During the past six years, we have performed more than 300 TMR procedures at The Washington Hospital Center. Long-term follow-up of these patients has demonstrated that TMR is an effective therapy for the relief of angina. Patients with small vessel disease receive a more complete revascularization when TMR is combined with coronary artery bypass than bypass alone."
The study entitled, "One-Year Outcome After Combined Coronary Artery Bypass Grafting and Transmyocardial Laser Revascularization for Refractory Angina Pectoris," is a clinical follow-up of outcomes after patients received coronary artery bypass graft surgery (CABG) plus TMR. From March 1996 through February 2000, 169 patients underwent combined CABG with TMR at the Washington Hospital Center. Relief from angina was significantly improved at 3, 6 and 12 months compared to preoperative statistics. Angina classifications are measured in classes ranging I to IV with IV being the most painful. Preoperatively, 152 patients (90 percent) had class III or IV angina compared with 5 patients (3 percent) at 3 months and 7 patients (4 percent) at 6 months and 12 months.
Interestingly, 82 percent of the patients in the study had previously been evaluated by other hospitals that perform heart surgery, and had been turned down as inoperable due to small vessels or diffuse disease. In addition, 52 percent of patients were diabetics and almost half had previously undergone CABG, which demonstrates that more conventional methods of revascularisation had been exhausted for many of these patients.
"This study adds to the growing body of evidence that TMR is a very successful therapy for treating coronary artery disease patients," stated Mark R. Tauscher, president and CEO of PLC Systems. "We believe this additional data will continue to raise the level of awareness of TMR in the cardiac marketplace."
PLC Systems Inc. is a medical device company specializing in the design and manufacturing of carbon dioxide (CO2) lasers and related disposable components to treat coronary artery disease. Edwards Lifesciences (NYSE: EW) is the exclusive U.S. marketer and distributor of PLC's CO2 Heart Laser 2 system, which a cardiac surgeon can utilize to perform CO2 Laser Revascularization. CO2 Laser Revascularization, pioneered by PLC Systems, is a surgical technology for treating severe angina, or heart pain.
The CO2 Heart Laser is the only revascularization laser that has published data showing long-term (five-year) angina relief in severely debilitated heart patients. 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 8,500 patients have been treated with a CO2 Heart Laser.
For more information on PLC and its products, please visit the company's Web site at http://www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. 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 CO2 Heart Lasers, no assurance that all payers will reimburse health care providers who perform TMR procedures or that reimbursement, if provided, will be adequate, and additional risk factors described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and our other SEC reports.
SOURCE: PLC Systems Inc.
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