First Patient Enrolled in reMARQable Clinical Study Evaluating the Safety and Efficacy of Multi-Electrode nMARQ™ Pulmonary Vein Isolation System™ in the Treatment of Paroxysmal Atrial Fibrillation
DIAMOND BAR, CA – May 9, 2013 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, today announced the first patient has been enrolled in the reMARQable clinical study. ReMARQable will assess the safety and efficacy of the use of the nMARQ™ Pulmonary Vein Isolation System to treat paroxysmal atrial fibrillation. Atrial fibrillation (Afib) is a heart rhythm disorder which affects approximately 20 million people worldwide.
Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center was first facility in the United States to use the nMARQ™ System to treat paroxysmal Afib as part of the clinical study. Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., cardiac electrophysiologist and executive medical director of TCAI, performed the first case in the United States, and was among the first to use this new catheter in Europe. “I am encouraged by the possibilities of this new system,” said Dr. Natale. “This technology could provide another tool to more effectively treat patients with paroxysmal Afib.”
“We are excited about the start of the pivotal U.S. clinical trial for this innovative new technology,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. “By combining the multi-ablation capability of nMARQ™ System with the proven irrigation technology and the unparalleled mapping accuracy of the Carto® 3 System, this new platform has been designed to reduce procedure time and complexity.”
The nMARQ™ System consists of a multi-electrode, irrigated catheter ablation system. Each nMARQ™ Catheter has 10 irrigation holes per electrode completely surrounding the electrodes. The reMARQable trial will enroll approximately 400 patients at up to 50 sites in the U.S. The study is being conducted under an FDA-approved Investigational Device Exemption, and the new catheter is not available in the United States outside of the reMARQable study. Further information is available at: http://clinicaltrials.gov/ct2/show/NCT01824394?term=remarqable&rank=1.
About AF and cardiac ablation
Atrial Fibrillation is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life.
Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. During cardiac ablation, energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy “disconnects” the pathway of the abnormal rhythm. Cardiac ablation is commonly used for “simple” arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. ThermoCool® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with Carto® Systems (excluding NaviStar® RMT ThermoCool® Catheter).
About Biosense Webster, Inc.
Biosense Webster, Inc., part of the Johnson & Johnson Family of Companies, pioneered EP diagnostic catheters more than 20 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and mapping tools. As the leader in EP navigation systems and ablation therapy, Biosense Webster, Inc. has technology that includes the largest installed base of cardiac mapping navigation systems worldwide in leading hospitals and teaching institutions. For more information about Biosense Webster and its products, please visit: www.biosensewebster.com.
Dr. Natale is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.
The US nMARQ™ Catheters and nMARQ™ Generator are approved for investigational use only and are not for sale in the United States. nMARQ™ Catheters and nMARQ™ Generator are approved for sale only in some countries-part of the European Union, Middle East and Africa Region.