FDA approves Medtronic's cryo-ablation balloon for AF

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The Arctic Front CryoAblation Catheter System from Medtronic has become the first cryoballoon ablation device for drug refractory paroxysmal atrial fibrillation (AF) to receive FDA approval.

The cryoballoon treatment involves a minimally invasive procedure that creates circumferential lesions around the pulmonary vein.

Conventional radiofrequency catheter ablation utilizes a point-by-point ablation technique that can result in recurrence of AF. The circumferential balloon method has been shown to decrease the time of the procedure, as well as the recurrence rate.

The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal-AF) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal AF.

The study showed that 69.9 percent of patients treated with the balloon technology were free from AF at one year, compared to 7.3 percent 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 percent), 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.

According to the Minneapolis-based Medtronic, the Arctic Front Cryoballoon is designed to be used with fluoroscopy and does not require the use of 3D mapping systems. The technologies used 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, 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.