US-based medical device company AtriCure has secured 510(k) clearance for the cryoFORM cryoablation probe, which offers increased probe flexibility to adapt to a variety of surgical ablation procedures.
Launched last year in Europe, under a CE mark, the cryoFORM probe is based on the company's cryoablation technology, utilising features such as thermal capacity to remove heat and active defrost which enables a quick and safe separation of the probe while maintaining the tissue's frozen state.
It is a 10cm malleable structure composed of stainless steel and has a retractable handle to increase its length.
AtriCure president and CEO Mike Carrel said: "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 equipment has a flexible tube set enabling tight bending radius and its ergonomic handle accommodates multiple hand positions.
The cryoFORM has the flexibility to suit to a range of surgical ablation procedures and is instrumental to address minimally invasive techniques by allowing surgeons to easily shape and position the probe using endoscopic instruments.
University of Leipzig heart centre department of cardiac surgery professor and co-director Dr. Martin Misfield said: "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."