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Cardiogenesis Announces Article Published in the Heart Surgery Forum Concludes TMR Clinically Proven Safe and Effective

CardioGenesis Corporation (OTC Bulletin Board: CGCP – News), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR) procedures, announced today that a team of leading physicians who have performed and developed a variety of approaches to TMR, including minimally invasive thoracoscopic and robotically assisted techniques, concluded in an article featured in the June 2004 edition of The Heart Surgery Forum, that TMR is a clinically proven, safe and effective therapy for physicians addressing some of the most difficult angina and revascularization cases. Angina is the often crippling pain associated with severe cardiovascular disease.

The authors of the article, titled “Transmyocardial Laser Therapy; A Strategic Approach,” also noted after reviewing several case studies that, “the use of TMR has added another important dimension to the overall management of angina patients, particularly those with no other treatment options.”

The comprehensive article in The Heart Surgery Forum, the official journal of The International Society for Minimally Invasive Cardiac Surgery (ISMICS), provided a detailed patient selection algorithm and case studies on the variety of approaches to TMR, including using TMR as a sole therapy, as an adjunctive therapy to coronary artery bypass grafting (CABG) and promising new, minimally invasive methods such as robot-assisted TMR.

The article’s featured author was Louis Samuels, M.D. of Lankenau Hospital of Wynnewood, PA, who shared the byline with eight other physicians from centers around the U.S. who are actively utilizing TMR in their cardiothoracic programs. Dr. Samuels underscored how TMR is evolving as surgeons become more familiar with the technology and experiment with new, minimally invasive approaches.

“Minimally invasive approaches (to TMR), including off-pump approaches and limited thoracotomies to enhance patient benefit and expand patient eligibility, are becoming a routine part of TMR strategy,” Dr. Samuels wrote. “Future applications in this regard include the use of port access (thoracoscopic approach) to minimize patient pain and recovery time and to avoid sternotomy in young patients.”

Chairman and CEO, Michael J. Quinn, said that publication of this important article on TMR in the current edition of The Heart Surgery Forum is particularly timely for the company as it has been published in conjunction with the annual ISMICS meeting being held in London later this month.

“During the past year there have been important new publications of clinical data regarding the enduring benefits of TMR, including publication of a five-year follow-up study demonstrating that patients treated with the procedure continued to experience reductions in angina pain after one year. The study also showed that TMR had a beneficial impact on long-term survivability,” Quinn noted.

The Society of Thoracic Surgeons Workforce on Evidence-Based Surgery recently endorsed the procedure in its published Practice Guidelines for TMR. “The publication by Dr. Samuels et al builds upon the scientific evidence supporting the therapy, by providing a thorough and thoughtful review of a significant body of clinical experience in outlining patient selection and procedural considerations,” Quinn added.

CardioGenesis is working with the physicians who are studying new and advanced approaches to TMR, including minimally invasive methods. These innovative approaches to TMR are much easier on the patient and lead to much quicker recovery times. “This is where TMR is headed and we have a number of new products on the way to assist in these approaches,” Quinn said.

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