FDA clears AtriCure’s CryoForm cryoablation probe

AtriCure (NSDQ:ATRC) said yesterday it won FDA 510(k) clearance for its  CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation.

The CryoForm is designed with the ability to remove heat and actively defrost, which allows the operator to safely detach the device while maintaining internal tissue’s frozen state, the West Chester, Ohio-based company said.

“We are excited to bring this new technology to the U.S. market. 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,” CEO Mike Carrel said in a press release.

The company said the probe allows for increased flexibility and easier manipulation to allow for better conformation in 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,” Dr. Martin Misfield of the University of Leipzig said in a prepared release.

In February, Atricure said it launched a clinical trial of its AtriClip left atrial appendage closure device, aiming to show whether the device reduces the incidence of post-operative atrial fibrillation after cardiac surgery to repair a structural heart defect.

AtriCure said the 1st patient in the 1-year Atlas trial was enrolled at PinnacleHealth Hospitals in Harrisburg, Pa. The study, which is slated to enroll up to 2,000 patients with a high risk of developing POAF, is designed to compare treatment with AtriClip in conjunction with a heart defect repair procedure to patients who undergo heart defect repair alone. It’s also designed to evaluate healthcare resource utilization between the 2 groups, AtriCure said.

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