nContact Announces Initiation of Clinical Trials for the Treatment of Atrial
Fibrillation in Open-Chest Procedures
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.
amoser@ncontactsurgical.com
Scott Lerman
The Ruth Group
T (646) 536-7013
slerman@theruthgroup.com
SOURCE nContact Surgical, Inc.
nContact, Inc., +1-919-466-9810, Fax, +1-919-466-9811, or Media, Angela Moser,
nContact Surgical, Inc., amoser@ncontactsurgical.com; or Scott Lerman, The
Ruth Group, +1-646-536-7013, slerman@theruthgroup.com
