September 2, 2008
Catheter Ablation System for Atrial Fibrillation Shows Reduced Procedure Time, Remarkable Safety Profile and Excellent Outcomes in Two Clinical Studies
CARLSBAD, Calif., Sept. 2 /PRNewswire/ -- Ablation Frontiers, Inc., announced today that two important studies, involving its innovative atrial fibrillation ablation products were presented by Dr. Lucas Boersma of the St. Antonius Hospital in Nieuwegein, Netherlands at the European Society of Cardiology (ESC) congress. One of the world's most prestigious scientific meetings for cardiologists, the ESC meetings took place from August 30 - September 3 in Munich, Germany.
Dr. Boersma's first study involved 45 patients with paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation (PAF) is characterized by a rapid rhythm of the heart's upper chambers that starts suddenly and stops without the need for medical intervention, yet can provoke severe symptoms. All patients were treated with ablation therapy at the antrum of the pulmonary veins (PV) designed to electrically isolate them from the left atrial body. This therapy has previously involved long procedure times and often required elaborate and expensive imaging technology. Using the circular decapolar Pulmonary Vein Ablation Catheter (PVAC(TM)) and GENius(TM) Multi-Channel Radiofrequency (RF) energy generator from Ablation Frontiers, 100% of the veins were isolated in 97 minutes (+/- 32 minutes) with just 20 minutes (+/- 9 minutes) of fluoroscopy. No complications were observed and 82% of the patients discontinued anti-arrhythmic drug therapy and were free of atrial fibrillation 9 months (+/- 2 months) following a single ablation procedure.
"PV isolation is a therapy option that is appropriate for many PAF patients, but can be difficult and time-consuming to perform with previous technologies. More importantly, there has traditionally been a small but significant complication rate. The Ablation Frontiers system has overcome those challenges," stated Dr. Boersma. "Use of the GENius generator and a single PVAC catheter for mapping, ablating and confirming isolation reduces the risk of complications and streamlines the procedure by eliminating the need for elaborate mapping and imaging technology. And it is quite effective, in that 82% of the patients had no evidence of atrial fibrillation 9 months after their treatment. This is an important finding, since so many patients with paroxysmal atrial fibrillation are visiting their healthcare provider for help."
The second study presented involved patients with permanent or persistent atrial fibrillation (PPAF), a more severe form of the arrhythmia in which the heart's upper chambers consistently beat in a seemingly chaotic way at very high rates. Patients with PPAF do not respond to standard medications, and many of them have to contend with ongoing and sometimes debilitating symptoms.
"Patients with PPAF represent an important but remarkably challenging subset of AF patients. Ablation Frontiers has the only ablation system expressly designed to treat these particular patients," continued Dr. Boersma. "This alone is a real breakthrough."
Fifty-one patients with PPAF were treated at 5 European centers using the GENius generator and PVAC, as well as two other anatomically-designed catheters from Ablation Frontiers -- the Multi-Array Septal Catheter (MASC(TM)) and Multi-Array Ablation Catheter (MAAC(TM)). Ablation therapy restored the heart to normal rhythm in 94% of the patients on the day of the procedure, with an average procedure time of 144 minutes (+/- 44 minutes) following transseptal puncture. Patients were followed for six months with a cumulative efficacy rate of 81%.
These excellent results align with the results presented recently at other leading scientific sessions from several other studies using Ablation Frontiers breakthrough technology.
"We are honored that a physician of Dr. Boersma's caliber and commitment is helping to demonstrate the value of our revolutionary technology with such studies," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "The results from these and other studies continue to show the remarkable safety profile of this technology, and that procedure times can be reduced while improving clinical efficacy for all types of AF patients."
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. Founded in 2004, Ablation Frontiers is dedicated to helping individuals suffering from AF and other cardiac arrhythmias. Working in concert with clinical experts in the field of ablation, the company is focused on developing and commercializing innovative products designed to make ablation procedures safer and less time consuming, thereby making it possible for more individuals to benefit from this life-bettering therapy. In 2006, Ablation Frontiers received the CE mark to begin marketing its system of unique ablation catheters and multi-channel RF generator in the European Union.
Ablation Frontiers, Inc.
CONTACT: Jay Kelley of Ablation Frontiers, Inc., +1-760-438-4868
Web site: http://www.ablationfrontiers.com/