Clearance brings an even more flexible probe to the U.S. market for
use in a variety of surgical interventions to treat cardiac arrhythmias;
product was launched in Europe in October 2015
MASON, Ohio--(BUSINESS WIRE)--Apr. 12, 2016--
ATRC), a leading innovator in treatments for atrial fibrillation
(Afib) and left atrial appendage management, today announced that it has
received 510(k) clearance for the cryoFORM cryoablation probe, which
offers increased probe flexibility to adapt to a variety of surgical
ablation procedures. The probe was previously launched in October 2015
in the European market under a CE mark.
“We are excited to bring this new technology to the U.S. market,” said
Mike Carrel, President and CEO of AtriCure. “Since the launch in Europe,
we have received very positive feedback from our customers, and are
looking forward to continued growth in our cryoablation platform.”
The cryoFORM probe builds off of the company’s core strengths in
cryoablation technology, leveraging such important features as thermal
capacity to remove heat and active defrost, which offers the increased
probe flexibility necessary for minimally invasive cardiac surgeries.
Building upon those strengths, the new probe offers increased
flexibility, allowing the surgeon to more easily manipulate and apply
the device and conform to challenging anatomies.
“The flexibility of cryoFORM, together with the automatic defrost
function of the CryoICE system, made us decide at the Heart Center
Leipzig to start using this product for our cryoablation procedures,”
said Dr. Martin Misfield, MD, PhD, Professor and Co-Director, Department
of Cardiac Surgery, Heart Center, University of Leipzig.
AtriCure, Inc. is a medical device company providing innovative atrial
fibrillation (Afib) solutions designed to produce superior outcomes that
reduce the economic and social burden of atrial fibrillation. AtriCure’s
Synergy™ Ablation System is the first and only surgical device approved
for the treatment of persistent and longstanding persistent forms of
Afib in patients undergoing certain open concomitant procedures.
AtriCure’s AtriClip® left atrial appendage management (LAAM)
exclusion device is the most widely sold device worldwide that’s
indicated for the occlusion of the left atrial appendage. The company
believes cardiothoracic surgeons are adopting its ablation and LAAM
devices for the treatment of Afib and reduction of Afib related
complications such as stroke. AtriCure recently acquired nContact, a
leader in minimally invasive technology for epicardial ablation.
nContact’s mission is to transform the underserved arrhythmia population
through a multidisciplinary epicardial-endocardial ablation approach.
Afib affects more than 33 million people worldwide. For more information
visit AtriCure.com or follow us on Twitter @AtriCure.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160412005137/en/
Source: AtriCure, Inc.
Valerie Storch-Willhaus, 612-605-3311
Director, Corporate Marketing and Communications
Senior Vice President
and Chief Financial Officer