nContact Announces Initiation of Clinical Trials for the Treatment of
Paroxysmal Atrial Fibrillation Utilizing New Convergent Ablation Procedure
MORRISVILLE, N.C., Dec. 1 /PRNewswire/ -- nContact Surgical, Inc.
("nContact"), a leader in the investigation of devices for minimally-invasive
treatment for heart conditions, today announced the initiation of a
feasibility clinical trial designed to evaluate the safety and efficacy of a
combined surgical and catheter procedure, the convergent procedure, for the
treatment of symptomatic paroxysmal atrial fibrillation (AF). This
prospective, feasibility study will enroll patients at study sites across the
United States.
"We designed this study to include paroxysmal patients with enlarged hearts,
who historically have been more difficult to treat with catheter ablation in a
single procedure," said John P. Funkhouser, President and CEO of nContact.
"The uniqueness of the convergent procedure is that lesions can be created on
all areas of the heart through a closed chest endoscopic approach, without
lung deflation, and while the heart is beating. It is hoped that the
combination of surgical and electrophysiology techniques will enhance
physicians' capability to ultimately treat all AF patients in a single
procedure."
The study utilizes the nContact Numeris®( )- AF Guided Coagulation System with
VisiTrax® along with a commercially available ablation catheter, the Biosense
Webster NaviStar®( )ThermoCool® Catheter. The combination of devices creates a
standard, bi-atrial lesion pattern to block electrical signals that cause AF.
In addition, electrophysiologists have the capability to diagnostically ensure
the lesion pattern is complete with pulmonary vein isolation. "We look
forward to investigating this collaborative, interdisciplinary approach for
the treatment of atrial fibrillation in patients with larger atria," said Dr.
Rodney Horton, Principal Investigator at St. David's Medical Center in Austin,
Texas.
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). The Numeris® Coagulation System with VisiTrax® is
based on the unique integration of suction, perfusion, and RF energy to ensure
the creation of visible, non-conductive, bi-atrial epicardial lesions on a
beating heart.
To date, The Numeris Coagulation System with VisiTrax is indicated for the
coagulation of cardiac tissue 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, F +1-919-466-9811; or Angela Moser, nContact
Surgical, Inc., amoser@ncontactsurgical.com; or Scott Lerman, The Ruth Group,
+1-646-536-7013, slerman@theruthgroup.com
