The FDA has approved Medtronic’s Arctic Front Cardiac CryoAblation Catheter system for the treatment of PAF (drug refractory paroxysmal atrial fibrillation) – a type of atrial fibrillation in patients who do not respond to medication; irregular heartbeats in the upper chambers start and stop suddenly on their own, usually for minutes or days at a time. Medtronic announced that it is the only Cryoballoon in the USA for such an indication. This minimally-invasive procedure effectively creates circumferential lesions around the pulmonary vein, which is the cause of inconsistent electrical signals that lead to the heart rhythm disorder (irregular heartbeat).

The catheter delivers a coolant that blocks conduction pathways that trigger atrial fibrillation. The device is inserted through an artery in the patient’s groin and is threaded until it reaches their heart. The freezing technology allows the catheter to stick to tissue during ablation, making it more stable.

Vivek Reddy, MD, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, NY., said:

    “This technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation. 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.”

A pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial showed that 69.9% of those treated with Arctic Front had no atrial fibrillation at one year, compared to 7.3% of those just on drug therapy. Apart from demonstrating the device’s efficacy, it was also shown to be safe, with limited procedure-related adverse events. Study participants had a considerable reduction of symptoms, less need for drug therapy, and significant improvements in mental as well as physical quality-of-life factors, Medtronic informs.

Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division, said:

    “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. 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 centers outside of the U.S., to physicians and patients in this country.”

The Arctic Front Cardiac CryoAblation Catheter System does not need the use of three-dimensional mapping systems. It is designed to be used with fluoroscopy.

The technologies included in this system are:

  • The Arctic Front Cryoballoon. It is filled with coolant to ablate (remove) tissue where the pulmonary veins enter the left atrium (of the heart)
  • The FlexCath® Steerable Sheath. It helps deliver and position the cryocatheter in the left atrium
  • The Freezor MAX Cardiac CryoAblation Catheter. This is a single-point catheter for extra ablations, when required
  • The CryoConsole. Where the coolant and electrical and mechanical components that run the catheters during a cryoablation procedure are housed.

Atrial fibrillation is the most common heart rhythm disorder in the USA; it is also one of the most undertreated. About 3 million US adults are thought to suffer from atrial fibrillation. A significant proportion, perhaps 40%, have no symptoms and are probably under-diagnosed.

About half of all patients diagnosed with atrial fibrillation do not respond to medication. If nothing is done, the risk of stroke increases fivefold; there is also a significantly greater likelihood of developing heart failure.

Source: Medtronic Inc.

Written by Christian Nordqvist