FDA And CE Approval For Medtronic’s New Cryoballoon Means Improved Pulmonary Vein Isolation

In short

Medtronic’s Arctic Front Advance™ Cardiac Cryoballoon has received both U.S. FDA approval and CE Mark for the treatment of paroxysmal atrial fibrillation (PAF). With the only cryoballoon system currently on the market worldwide, Medtronic’s second-generation system provides a more efficient approach to treating PAF than point-by-point, radiofrequency (RF) ablation.

Background

We hear a lot about Radiofrequency(RF), and even laser ablation, the two commonest heat-based modalities employed for cardiac ablation in arrythmia correction, as the cardiologist seeks to isolate the pulmonary vein, the electrical source of the arryhthmia. At the opposite end of the temperature spectrum, Medtronic’s cryoballoon uses coolant rather than heat. Delivered via a catheter, cryoballoon technology is associated with faster procedure times versus point-by-point, RF ablation. Additionally, Medtronic says 73 percent of patients subjected to its cryoablation technique achieved freedom from AF at one year1,2, a clinically significant increase in success over AF drug therapy1,2.

In a press release announcing the new approval, Medtronic tells us that the first-generation Arctic Front Cardiac CryoAblation Catheter System is the world’s leading cryoballoon system indicated for the treatment of PAF. The system has experienced rapid worldwide adoption and clinical experience since its introduction onto the market, having been used to treat approximately 35,000 patients in more than 400 medical centers in 25 countries.

Compared with the RF-based targeted treatments, the Arctic Front Advance Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems.

The cleverly named system features the new EvenCool™ Cryo Technology, which optimises the delivery of coolant inside the balloon. As a result, the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, and improves physicians’ ability to treat patients with complicated anatomies compared to the original Arctic Front® CryoAblation System.

Clinician comments

“With Arctic Front Advance, we are now able to more effectively treat a broader range of pulmonary vein anatomies with less effort, which can potentially reduce procedure times,” said Vivek Reddy, M.D., director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York.

“The original Arctic Front technology has become a standard for AF ablation based on its safety, efficacy and relative ease of use,” said Karl-Heinz Kuck, M.D., director of cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. “The second-generation system builds on this solid foundation, while offering more sophisticated features that should benefit both the physician and patient.”

Company comments

“We anticipate this next generation balloon will be enthusiastically received by physicians worldwide. Our aim is to offer physicians the best solutions for treating serious cardiovascular diseases such as atrial fibrillation, and improving overall patient quality-of-life, while delivering economic value,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “Our cadence of product launches showcases significant enhancements: This is the second revolutionary balloon-based medical technology we’ve launched in the past 18 months in the U.S. to treat AF.”

References

1 Andrade JG, Khairy P, Guerra PG, et al. Efficacy and safety of cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. September 2011;8(9):1444-1451.
2 Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. August 2009;2(4):349-361.
3 JAMA 2001; 285:2370-5.
4 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.

Source: Medtronic Inc.,