CARLSBAD, Calif., April 24 /PRNewswire/ -- Ablation Frontiers, Inc., today announced that data on the first five patients enrolled in a study involving its novel RF ablation catheter and generator were presented by Dr. Stefania Riva at the 7th Annual Session of the Italian Association of Arrhythmology and Cardiac Pacing on April 3, 2008 in Milan. The patients, two of whom presented with permanent atrial fibrillation and three with paroxysmal atrial fibrillation, underwent successful pulmonary vein isolation without any reported complications. Procedure times averaged 32 minutes and after three months median follow-up (range: one to five months), four of five patients were in sinus rhythm.
The procedures were conducted using the PVAC(TM) Pulmonary Vein Ablation Catheter and multi-channel GENius(TM) Generator for Ablation Catheters. The PVAC was used for both mapping and ablating during the procedures. "The use of a single mapping and ablation catheter has streamlined and simplified the procedure," stated Dr. Stefania Riva.
Atrial Fibrillation is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat extremely fast and in an apparent chaotic rhythm. Symptoms include palpitations, dizziness and shortness of breath. Left untreated AF patients are at an increased risk for stroke and may also develop heart failure or other cardiac rhythm disorders. AF is most frequently treated with drug therapy but recent surgical advances targeting the electrical isolation of the pulmonary veins (near the left sided upper chamber) have demonstrated success at eliminating the rhythm disorder. While results of these surgical techniques hold promise, the invasiveness of the procedures makes them challenging, time consuming and subject to complications.
"The lack of perioperative and postoperative complications is of key importance," stated Dr. Riva. "As of this date, one patient in our study with paroxysmal AF has stopped taking all anti-arrhythmic medications. While our study is still underway, I find these interim results quite encouraging."
Ablation Frontiers, Inc. is pioneering new technology designed to make AF ablation safer for patients, faster and easier for physicians, and more appropriate for a broader spectrum of patients. Older ablation approaches are often considered only for those patients with paroxysmal AF, the mildest form of the disease.
"We are very much encouraged by these interim results and sincerely thank Dr. Paolo Della Bella, Chief of the Arrhythmology Department at the University of Milan's Institute of Cardiology and one of the authors along with his colleagues for their outstanding work in this study and their dedication to finding a cure for AF," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "These preliminary data show the promise of the Ablation Frontiers technology for patients with either permanent or paroxysmal atrial fibrillation. This early report aligns well with anecdotal data from other clinics in Europe. We are very pleased with the resonance this new device is finding in the clinical community."
About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias. In late 2006, Ablation Frontiers received the CE Mark to begin marketing in the European Union with its portfolio of anatomical-based catheters and a multi-channel RF generator. To learn more about the company, visit www.ablationfrontiers.com. Ablation Frontiers products are currently distributed in Italy by the company's distribution partner Manta srl.
Manta has specialized in interventional cardiology products for the past 15 years. Based in Genoa, Italy, the company distributes a variety of electrophysiology products including the innovative catheters and GENius generator from Ablation Frontiers. The company website is www.manta.it.
SOURCE Ablation Frontiers, Inc.