Nov 15 2007
MedicalCV, Inc., announced today the completion of the 75th surgical case utilizing its laser-based technology platform, which includes both the ATRILAZE and SOLAR Surgical Ablation Systems.
To date, cardiothoracic surgeons from 10 leading institutions have performed a total of 75 cardiac ablations using the ATRILAZE System, the SOLAR System, or a combination of the two, in open and closed-chest procedures. This includes 65 ablations that were performed concomitantly (in conjunction) with other open-chest cardiovascular procedures and 10 that were performed in stand-alone, minimally invasive, closed chest settings.
"MedicalCV's technology lends itself well to both open and closed-chest cardiac ablation procedures," said Vibhu R. Kshettry, M.D., a prominent cardiac surgeon from Abbott Northwestern Heart Hospital in Minneapolis, MN, who completed three beating heart cardiac ablation procedures using MedicalCV's laser-based technology platform last week. "Using a combination of the ATRILAZE and SOLAR Surgical Ablation Systems, I was able to complete three successful ablation procedures."
Marc P. Flores, President and CEO of MedicalCV stated, "We are very pleased with the performance of our products in both the open and closed-chest settings and that these leading cardiac institutions are beginning to utilize our products as a complete cardiac ablation solution." Flores added, "During the first half of calendar year 2008, we plan to build our sales force while continuing to collect clinical data for expanded indications and publications.
While driving market adoption of our laser-based technology platform, we will collect and provide additional clinical data for the purpose of educating physicians and patients. We believe physician and patient education and awareness are increasingly important factors in the adoption of new medical treatments."
The SOLAR System received FDA clearance for the ablation or coagulation of soft tissue in March 2007. This builds on previous clearances for the company's ATRILAZE System for the delivery of laser light to soft tissue, including cardiac tissue, during surgical procedures. However, the products are not labeled for the treatment of cardiac arrhythmias, which is specifically excluded for both ablation systems.
To date, the company's laser-based technologies have been used in institutions around the country including Baylor University Medical Center, University of Michigan Medical Center, Chicago's Northwestern Memorial Hospital, Baptist Medical Center in San Antonio, Texas, Abbott Northwestern Heart Hospital in Minneapolis, Minnesota, Wisconsin Heart Hospital in Milwaukee, Wisconsin, Morton Plant Heart Hospital in Clearwater, Florida, as well as Arizona's Scottsdale Shea Hospital, Banner Good Samaritan Medical Center and Banner Baywood Heart Hospital.