MORRISVILLE, N.C., Nov. 16 /PRNewswire/ -- nContact Surgical, Inc. ("nContact"), a leader in the investigation of devices for non-invasive treatment for heart conditions, today announced the initiation of a clinical trial designed to evaluate the safety and efficacy of its Numeris® - AF Tethered Coagulation System with VisiTrax® device in an open-chest concomitant procedure for the treatment of longstanding persistent atrial fibrillation (AF). This multi-center, non-randomized, prospective clinical trial will enroll up to 107 participants at 15 study sites across the United States.
"We developed our coagulation system based on the integration of suction, perfusion, and energy to create non-conductive, bi-atrial lesions. What is unique about this study is that we are creating a comprehensive lesion pattern on a beating heart to interrupt atrial fibrillation circuits located across both atria," said John P. Funkhouser, President and CEO of nContact. "Our hope is that this study will lead to participants being free from AF and completely off class I and class III antiarrhythmic drugs (AADs)* following their treatment."
The clinical trial procedure involves creating a bi-atrial lesion pattern on a beating heart to block electrical signals that cause AF. The lesions are created using nContact's tethered device on the upper chambers of the heart, the left and right atria, where the AF occurs. Once the lesions have been created, a cardiothoracic surgeon will be able to confirm intra-operatively through pacing whether the lesions are non-conductive and the pulmonary veins are isolated.
"The nContact technology enables me to create a comprehensive biatrial lesion pattern on a beating heart. We look forward to investigating the ability to treat atrial fibrillation in patients undergoing open heart surgery with the hope of establishing the lesion pattern with superior results," commented Dr. Edward Garrett, Jr., Principal Investigator from Baptist Memorial Hospital Heart Institute, Memphis.
For more information about the Numeris-AF Tethered Coagulation with VisiTrax trial, please visit www.clinicaltrials.gov (study number NCT00950092).
*The decision to stop the use of AADs will be decided by each participant's physician evaluation of the participant's medical status.
About nContact Surgical, Inc .
nContact is a medical device company founded in 2005 with the company mission to develop devices for the endoscopic treatment of arrhythmias, including atrial fibrillation (AF).
To date, The Numeris® Coagulation System with VisiTrax® is indicated for the coagulation of cardiac tissue (resulting in lesion creation) in the United States. nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. The Numeris Coagulation System with VisiTrax has CE Mark approval in Europe for the specific indication for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.
nContact, Inc. 1001 Aviation Parkway, Ste 400 Morrisville, NC 27560 T (919) 466-9810 F (919) 466-9811 Media Contacts Angela Moser nContact Surgical, Inc. firstname.lastname@example.org Scott Lerman The Ruth Group T (646) 536-7013 email@example.com
SOURCE nContact Surgical, Inc.
|SOURCE nContact Surgical, Inc.|
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