MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and
Drug Administrations (FDA) Circulatory Systems Devices advisory panel voted
against the Medtronic Phased RF Ablation System, the first atrial fibrillation
ablation therapy under investigation for the treatment of persistent and
long-standing persistent atrial fibrillation. While the panel unanimously
agreed the technology is effective, the majority did not believe there is
reasonable assurance of the safety of the Medtronic Phased RF Ablation System,
and that the clinical benefits of the technology do not outweigh the potential
risks based on the TTOP-AF clinical trial data.
Todays committee recommendation, although not binding, will
be considered by the FDA as it reviews the pre-market approval application for
the Medtronic Phased RF Ablation System. Medtronic submitted a modular
pre-market approval (PMA) application with the last submission completed in
June 2011 based on data from its pivotal TTOP-AF (Tailored Treatment of
Persistent Atrial Fibrillation) clinical trial, the first randomized study
comparing ablation therapy to traditional medical management (antiarrhythmic
drugs and direct current cardioversion) in patients with persistent or
long-standing persistent atrial fibrillation.
“While we are disappointed with todays outcome, Medtronic
looks forward to continuing discussions with the FDA to determine the best path
forward,” said Reggie Groves, vice president and general manager of Medtronics
AF Solutions business. “We believe this technology would represent an important
option for the persistent or long-standing persistent atrial fibrillation
population, for whom treatment is limited.”
Currently, the only FDA approved atrial fibrillation
ablation medical devices are indicated for the treatment of paroxysmal atrial
fibrillation, a type of disease in which irregular heartbeats in the upper
chambers start and stop suddenly on their own, usually for minutes or days at a
time. As the disease progresses into persistent (recurrent episodes that last
more than 7 days) or long-standing persistent (continuous episodes that last
more than one year) atrial fibrillation, it becomes more complex to treat.
Persistent atrial fibrillation patients often have increased hospitalizations
and healthcare costs, and the condition is more debilitating in terms of
quality of life.
Results from the TTOP-AF clinical trial were presented on
October 10, 2011 at Venice Arrhythmias 2011, the 12th International Workshop on
Cardiac Arrhythmias. The study met its chronic effectiveness endpoint,
demonstrating that 55.8 percent of patients treated with the Medtronic Phased
RF Ablation System had an atrial fibrillation and atrial flutter burden
reduction of greater than 90 percent and were free from antiarrhythmic drug therapy
at six months, compared to 26.4 percent in the traditional medical management
arm (p<0.0001). When including patients still on antiarrhythmic drug therapy
following the procedure with the ablation system, 67.4 percent had a greater
than 90 percent reduction of atrial fibrillation burden at six months.
The acute safety event rate in the trial was 12.3 percent
with an upper 95 percent confidence interval of 19 percent, which did not meet
the pre-defined performance goal of 16 percent. At the time the trial was
designed, no benchmark for the persistent atrial fibrillation patient
population existed, so the performance goal of 16 percent was established based
on a literature review evaluating ablation procedures in paroxysmal atrial
fibrillation ablation patients. These specific safety findings were not
unexpected since persistent or long-standing persistent atrial fibrillation
patients undergoing ablation have a higher risk of adverse events due to the
advanced state of the disease and the complexity of the procedure.
The Medtronic Phased RF Ablation System is investigational
in the United States and
currently approved for use in areas of Europe, Asia, and Africa, as well as in Canada. More
than 13,000 patients in 24 countries have been treated with the system since
January 2009.
About the Medtronic Phased RF Ablation System
The Medtronic Phased RF Ablation System is a percutaneous cardiac catheter and
generator system that delivers customized radiofrequency (RF) energy designed
to eliminate or isolate abnormal electrical impulses in the left atrium (upper
left chamber of the heart) that initiate or sustain atrial fibrillation. The
anatomically designed, multi-electrode catheters are intended to allow
physicians to identify and selectively ablate a broader area of heart tissue
without the use of current single point catheters and complex mapping and
navigation equipment.
The Medtronic Phased RF Ablation System includes:
- Pulmonary Vein Ablation Catheter (PVAC)™ – designed for
mapping, ablating and verifying isolation of the pulmonary veins; - Multi-Array Septal Catheter (MASC)™ – designed for mapping
and ablating the left atrial septal wall; - Multi-Array Ablation Catheter (MAAC)™ – designed for mapping
and ablating the left atrial body; and - GENius Multi-Channel Radiofrequency Generator – the unique
RF energy delivery system allows physicians to tailor the location, depth and
fill of each ablation lesion.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology – alleviating pain, restoring health, and extending life for
millions of people around the world.
