Investigators call the System 'A Genuine Advance in AF-Ablation Technology'
CARLSBAD, Calif., Oct. 28 /PRNewswire/ -- Ablation Frontiers, Inc., announced today that two important abstracts which evaluated its innovative Atrial Fibrillation (AF) cardiac ablation system were presented at the 5th Annual Heart Rhythm Congress. The studies, conducted independently, were led by Dr. Steve Murray of James Cook University Hospital in Middlesborough, UK, as well as Dr. Simon James and Dr. John Bourke of the Freeman Hospital in Newcastle upon Tyne, UK. The Heart Rhythm U.K. Congress was held from October 19-22, 2008 in Birmingham, UK.
Dr. Murray's abstract contrasted AF ablation results using a conventional ablation catheter with the aid of a 3D mapping system against his current approach using the new Ablation Frontiers System. The system consists of the advanced multi-channel phased GENius RF generator and a set of 3-D anatomically designed catheters (PVAC, MASC and MAAC) capable of mapping, ablating and pacing at target sites throughout the right and left atria.
Using this new technology, a total of 62 patients underwent AF ablation for either persistent (n=23) or paroxysmal AF (n=39). Sinus rhythm was acutely restored in 100% of patients and there were no major complications.
For those patients with persistent AF, the advanced form of the disease process, 17 were first-time ablation patients and six had received an ablation using alternate ablation technologies. For 16 patients that had been followed for 6 months or more, 10 were free of symptoms and had their anti-arrhythmic drug therapy discontinued.
Within the paroxysmal AF patient cohort, 31 of the patients were undergoing their first ablation, while 8 had failed their previous ablation using an alternate ablation technique. Procedure times were consistently under 90 minutes. At an average of 6 months follow-up, 35 of the 39 (90%) patients were free of AF symptoms and no longer taking anti-arrhythmic medication.
"In light of the clinical success rates, significantly reduced complication rates, and reduced procedure times, our center is fully adopting this new technology," stated Dr. Murray. "Prior to this approach, our drug-free success rate in one series of 63 patients with persistent and paroxysmal AF treated by conventional catheter ablation technology was 68% with a 7% complication rate."
The second abstract authored by Dr. James and Dr. Bourke evaluated 65 patients with drug-refractory AF, of which 17 had persistent AF and 48 had paroxysmal AF. Pulmonary vein isolation (PVI) was performed, with further ablation for sites of complex fractionation, as needed (n = 31). Acute success was achieved in 64 of the 65 patients and, at a mean follow-up time of 9.1 months, 88% of patients were free of AF as measured by 7-day continuous monitoring. The mean procedure time was 165 minutes for both types of AF, which was significantly shorter than the reported 208 minutes when using conventional ablation technology.
"The PVAC catheter is a genuine advance in AF-ablation technology," stated Dr. James. "With conventional RF technology for PVI, physicians are faced with a challenging and time-consuming procedure with variable success rates. We found that with the Ablation Frontiers technology, we could achieve high acute success rates and low recurrence rates of AF with significantly shorter procedure times. Medium-term follow-up data is encouraging."
These results are similar to findings presented recently at other leading scientific sessions from several studies using Ablation Frontiers novel technology.
"We are committed to the ongoing research of our innovative AF ablation technology and look forward to long-term results from these and other studies," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "We are very grateful to the investigators and their colleagues, who have been most diligent in thoroughly investigating Ablation Frontiers technology and reporting their findings. It is their work that helps us develop the technology that will one day overcome the growing challenge of atrial fibrillation."
About Atrial Fibrillation
Atrial fibrillation (AF) is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat in an extremely fast and seemingly chaotic rhythm. Symptoms include palpitations, dizziness, and shortness of breath. Clinicians differentiate AF by classifying it paroxysmal, persistent or chronic. Paroxysmal AF is characterized by sudden onset; the rhythm disorder often resolves on its own without medical intervention, although intervention can be useful. Symptoms of paroxysmal AF range from none (asymptomatic AF is not uncommon) to severe. Persistent AF is more serious in that AF tends to be more stubborn; medical intervention is required to resolve the rhythm disorder. Chronic AF is the most severe form and it occurs when the rhythm disorder no longer responds to medical treatment and no longer self-terminates. Current treatment options for AF include drug therapy (not always effective and associated with side effects), cardioversion, and ablation. Left untreated, AF patients are at increased risk for stroke and may also develop heart failure or other cardiac disorders.
About Ablation Frontiers
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 portfolio of anatomically based catheters and a multi-channel RF generator in the European Union.
CONTACT: Jay Kelley of Ablation Frontiers, +1-760-438-4868
Web site: http://www.ablationfrontiers.com/