Cardiovascular Business - November/December 2008 - (Page 23)

The axcis PMr system from Cardiogenesis has Ce Mark in europe but not FDa approval in the U.s. Myocardium Channels Co2 Laser Allen et al cited several studies that used PET imaging and echocardiography to demonstrate an improved myocardial blood flow in lased regions. In those studies, there also was no perfusion improvements “following a sham thoracotomy or the use of a non-injury-producing laser.” Horvath says that he has conducted preclinical studies with MRI and echocardiography that show an improved perfusion and regional wall motion after therapy with the CO2 laser but not with the Ho:YAG device. Horvath has yet to find a publisher for the studies. Richard P. Lanigan, president of Cardiogenesis, says that the Ho:YAG laser device used by Leon relied on a single pulse delivered to the endocardial surface of the left ventricle to an average of 20 locations, compared to an average of 35 full-thickness channels performed in surgical TMR. “From a dosage perspective, Dr. Leon’s laser system delivered approximately 5 percent the amount of directed laser energy to the targeted heart muscle compared to surgical TMR,” Lanigan says. The Cardiogenesis percutaneous system that uses a multiple-pulse Ho:YAG device has shown a good response rate, he says, adding that Leon’s conclusions should be applicable only to the specific system he used. Transmyocardial revascularization (TMr) uses a laser to create millimeter-sized channels through the myocardium to promote increased blood flow and diminish chronic refractory angina. source: PLC Medical systems Percutaneous or not In 1998, Cardiogenesis received the CE Mark for its Axcis PMR system. Study results showed the device contributed to a 50 percent reduction in mean angina class and a significant improvement in exercise tolerance. Lanigan says the company has continued to work with the FDA towards approval of its percutaneous delivery devices, but that his main focus is on advancing the company’s TMR technology. In 2007, the FDA approved a minimally invasive robotic hand piece delivery system, the PEARL 5.0, from Cardiogenesis, that works in conjunction with Intuitive Surgical’s da Vinci robotic system. Lanigan says that studies show a procedure time similar to traditional thoracotomy approach, which “is enlightening because critics of robotics in cardiac surgery complain that it is cumbersome.” In 2006, the company gained CE Mark for the Phoenix, which combines the delivery of a therapeutic biologic with TMR laser therapy. The company is working with several European centers in the initial clinical application of the device. PLC Medical, on the other hand, has no plans to develop PMR devices, according to Tauscher. PLC continues to educate cardiologists and referring physicians about the risk versus benefits of TMR. “Within the context of a surgical intervention for a relatively sick group of patients, TMR has a 2 to 3 percent risk, consistent with CABG procedures. I think many patients would be willing to take on that risk, but they can’t if their physicians don’t know about or understand TMR,” he says. Tauscher is encouraged because PLC’s second quarter revenues rose over first quarter sales this year. In March 2007, Novadaq Technologies acquired the rights to sell and market PLC’s CO2 TMR laser device domestically. Tauscher says the partnership could prove fruitful, given Novadaq’s intraoperative imaging technology, which could “influence the application of TMR.” Perhaps the best outreach effort would be to trot out Gibbs, who was told 12 years ago “to go home and pray.” Prior to her TMR treatment, she had received a variety of therapies including numerous medications, several interventions and two coronary bypass surgeries. “Many more patients can be given an option to live pain-free through TMR if only their cardiologists and referring physicians know about the technique,” Tauscher says. CardiovascularBusiness.com Cardiovascular Business 23 http://www.CardiovascularBusiness.com

Table of Contents Feed for the Digital Edition of Cardiovascular Business - November/December 2008

Cardiovascular Business - November/December 2008 Contents First Word Cover Story: Practice Management Software Moves Beyond Bean Counting The Death of CME as We Know It? Clinical Study Digets: Triple-Antiplatelet Therapy; Ex-Vioxx Users Beware Shockwaves Subside from the FDA's Echo Contract Warning Burning Question: Does Laser Heart Therapy for Angina Really Work? Advanced Visualization Adds New Practive Dimension Coronary Calcium Scoring Program Reaps Dividends Interventionalists Get Pumped Up About Mechanical Chest Compression Trials Force Physicians to Re-Examine Oral Anti-Diabetic Drug Protocols News & Views Calendar Reader Resources The ACC Corner

Cardiovascular Business - November/December 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.