Medical device company AtriCure has received 510(k) clearance from the US Food and Drug Administration (FDA) for its cryoFORM cryoablation probe.
Last October, the company secured CE mark approval for cryoFORM, which provides enhanced probe flexibility to adapt to different surgical ablation procedures.
The cryoFORM features cryoablation technology, which offers thermal capacity to remove heat and active defrost. It also provides increased probe flexibility necessary for minimally invasive cardiac surgeries.
In addition, the cryoFORM enables the surgeon to easily manipulate and apply the device and conform to challenging anatomies.
AtriCure president and CEO Mike Carrel said: "We are excited to bring this new technology to the US 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."
AtriCure also produces Synergy ablation system to treat persistent forms of atrial fibrillation (Afib) in patients undergoing certain open concomitant procedures. The firm also markets AtriClip left atrial appendage management (LAAM) exclusion device.
The company recently acquired nContact, which provides minimally invasive technology for epicardial ablation.