Healthcare Industry News:  AtriCure 

Devices Interventional Cardiology FDA

 News Release - April 12, 2016

AtriCure Announces 510(k) Clearance for the cryoFORM(TM) Cryoablation Probe

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--(Healthcare Sales & Marketing Network)--AtriCure, Inc. (Nasdaq: 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.

About AtriCure

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.


Source: AtriCure

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