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.
Ablation Frontiers