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FDA Clears AtriCure Cryoablation Probe

Probe has thermal capacity which increases flexibility.

By: AtriCure Inc.

AtriCure Inc., which makes atrial fibrillation (Afib) and left atrial appendage management technology, 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 last year 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 receivedvery 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 Martin Misfield, M.D., Ph.D., professor and co-director, Department of Cardiac Surgery, Heart Center, University of Leipzig.

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