nContact Announces: Study of Novel Convergent Procedure Demonstrates Improved Results Under Stringent Analysis at 12 Months in Difficult-to-Treat Patients

North America, United States

12/12/2012 — MORRISVILLE, N.C. — (BUSINESS WIRE)

Heart Rhythm Journal has published a 12-month, 100 patient outcome study evaluating the Convergent Procedure, an epicardial-endocardial technique to treat patients with atrial fibrillation (AF), the most common cardiac arrhythmia. The physician study reported outcomes of 66 percent arrhythmia-free survival after a single procedure at one year. Patients were treated at First Health of the Carolinas Moore Regional Hospital and UNC Heart & Vascular Clinic at the University of North Carolina-Chapel Hill.

“The Convergent Procedure was used with success in the most difficult-to-treat patient cohort to date,” said Paul Mounsey, BM BCh, PhD, MRCP, FACC, Professor and Director of Electrophysiology in the Department of Medicine, Division of Cardiology, the University of North Carolina-Chapel Hill. “To see such an improvement in survival outcome analysis is significant, given it is one of the most stringent reporting standards. Survival outcome analysis is an unusual standard for the primary endpoint of a paper. Utilizing more traditional endpoints such as Freedom from AF, the outcomes would have been 79 percent at one year.”

The study included 101 patients, all of whom had AF with disabling associated symptoms and had previously failed medical management with a class I or class III antiarrhythmic medication. Eighty-four (84) percent of patients had persistent or long-standing persistent AF and with an average CHADSVASC score of 2.1. Patients were followed with 24-hour Holter monitors at 3, 6 and 12-month intervals.

“The Convergent Procedure has been an important addition to my practice, enhancing my ability to treat and provide a better standard of care for the more persistent AF patient population,” said Dr. Mounsey. “The Convergent Procedure is the least invasive epicardial-endocardial procedure for the treatment of atrial fibrillation as it does not require chest incisions, ports or lung deflation, which can increase recovery times significantly.”

Epicardial access is gained through a small midline incision in the abdomen allowing entrance through the diaphragm to the atrium. By utilizing direct endoscopic visibility and epicardial ablation, the posterior wall can be electrically isolated. The wall is considered a key location for arrhythmogenic substrates in persistent and long standing persistent patients. Isolating the posterior wall of the atrium is a key advantage of the surgical portion of the procedure.

The primary advantage of the Convergent Procedure is utilizing a multi-disciplinary approach to ensure more comprehensive and complete treatment. In the combined approach, all areas of the heart can be reached and addressed, while a system of diagnostic “checks and balances” can be used to ensure electrical isolation of the posterior and pulmonary veins as well as lesion completeness to predict outcome.

About nContact, Inc.

nContact, Inc. is the leading innovator in epicardial ablation devices and techniques. Its mission is to transform the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias.

Its lead technologies, the EPi-Sense® and Numeris® Coagulation Systems with VisiTrax®, have CE Mark approval in Europe for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.

The EPi-Sense® and Numeris® Coagulation Systems with VisiTrax® are indicated for endoscopic coagulation of cardiac tissue in the United States. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, U.S.A.


CONTACT:

nContact, Inc.
Beth Rose, 919-655-1566
brose@ncontactinc.com
or
Spectrum
Lissette Capati, 202-587-2550
lcapati@spectrumscience.com

 

KEYWORDS:   United States  North America  North Carolina

INDUSTRY KEYWORDS:   Health  Cardiology  Medical Devices  Research  Science  General Health

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