FDA approves cryoballoon ablation treatment for paroxysmal AF


The FDA has approved the Arctic Front Cardiac CryoAblation Catheter system for the treatment of drug refractory paroxysmal atrial fibrillation (AF) in the USA.

Balloon-based technology is novel because it ablates or blocks the conduction of AF in cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.

“This technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation,” said Vivek Reddy, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, USA. “This unique ablation approach fills an unmet need in AF ablation by providing a straightforward and efficient approach to pulmonary vein isolation, while giving patients a new, minimally-invasive treatment approach proven to be safe and effective.”

The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained treatment of paroxysmal atrial fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation. The study showed that 69.9% of patients treated with Arctic Front were free from atrial fibrillation at one year, compared to 7.3% of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1%), and patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.

“This next-generation technology demonstrates Medtronic’s commitment to providing physicians with innovative solutions proven to help them efficiently, effectively and safely treat patients suffering from Atrial Fibrillation,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “We are now able to offer this novel technology, which has already been used to treat more than 10,000 patients in more than 200 centres outside of the US, to physicians and patients in this country.”

Medtronic acquired US-based Ablation Frontiers, and Montreal-based CryoCath Technologies, to form Medtronic’s AF Solutions division within the Cardiac Rhythm Disease Management business. When combined with Medtronic’s existing EP Systems product portfolio, AF Solutions offers an extensive line of diagnostic, cryoablation and radiofrequency ablation tools to diagnose and treat a broad spectrum of cardiac arrhythmias.

About the Arctic Front Cardiac CryoAblation Catheter System
The Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems. The technologies offered in the system include:

  • The Arctic Front Cryoballoon, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium;
  • The FlexCath Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium;
  • The Freezor MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and
  • The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure.