An Arctic Front is one step closer to coming on the U.S. horizon.
No, not the typical arctic front with extreme temperatures and ice, but rather a cryoablation balloon catheter which allows for physicians to isolate all four pulmonary veins for paroxysmal atrial fibrillation (PAF).
CryoCath Technologies (Montreal) designed the device and released results from three European study centers using the Arctic Front in the July 22 edition of the Journal of the American College of Cardiology (JACC).
The peer-reviewed article titled, "Circumferential Pulmonary Vein Isolation with the Cryoballoon Technique," discusses the three-center trial in which 74% of the 293 paroxysmal AFib patients enrolled were AFib free and off anti-arrhythmic drugs (AADs) after only one procedure with Arctic Front upon a median follow-up time of 12 months.
"It is quite standard in the medical profession, right now for patients to go through [numerous] AFib procedures before the procedure is successful," Jean Pierre Desmarais, chief scientific officer of CryoCath, told Medical Device Daily. "The Artific Frony is boasting no repeat procedures."
Of the 346 patients enrolled in the study, 293 were predominantly paroxysmal AFib sufferers, with a small group of persistent AFib patients numbering 53.
Of the 1,403 pulmonary veins treated, 1,360 (or 97%) were ablated with Arctic Front or Arctic Front in combination with CryoCath's Freezor MAX catheter demonstrating the broad applicability of Arctic Front cryoablation.
The median number of applications per vein was 2.8 and the median total procedure time was 170 minutes, which CryoCath said confirms the ease of use and speed with which physicians are able to use Arctic Front compared with other ablation technologies.
The safety data reported in the article confirms the strong safety profile Arctic Front has demonstrated to date. There were no observed reports of atrio esophageal fistula, stroke, death or peri-interventional complications. Phrenic nerve palsies were reported in 7.5% of patients treated; in some instances these were resolved prior to the end of the procedure or hospital discharge and all cases were resolved by the 12-month follow up visit.
Here's how the device works.
A balloon is inserted via a catheter through a vein, usually in the groin. The balloon is then frozen to around -60 C, using compressed nitrous oxide gas. The gas can achieve a temperature as low as -92 C.
The device causes cells to malfunction so that they can no longer hinder electrical impulses that control the heart's rhythm.
"Our biggest differing factor is the use of cryo," Jeff Silver, Cryocath market manager, told MDD. "Other techniques use ultrasound or microwaveable energy ... so heat is involved."
He emphasized the difference by describing the radical changes in temperature of a sponge.
"If you use heat, then you burn the sponge," Silver said. "You may get it in the shape of a crater or it might shrink. But, if you use a cooling technique, the structure remains intact. Currently there is no gold standard to treating PAF, but we believe [Artic Fox] will become that standard."
Pending FDA approval, the company is looking to launch the product in the U.S. in late 2009.
So far more than 2,600 patients have been treated with the device in more than 45 centers across Europe.
CryoCath Technologies is engaged in creating minimally invasive, catheter cryotherapy products to treat cardiovascular diseases.
The company's range of catheter and probe designs for the treatment of achyarrhythmia includes focal catheters (Freezor, Freezor Xtra and Freezor MAX) and balloon catheter (Arctic Front) cryoablation products. Freezor, Freezor Xtra and Freezor MAX catheters are deflectable and torquable, incorporating three electrocardiogram rings and a temperature sensor at the tip for temperature monitoring and control.