MONTREAL, Oct. 28 /PRNewswire-FirstCall/ -- CryoCath Technologies Inc., the global leader in cryotherapy products to treat cardiovascular disease, today announced it has filed an Investigational Device Exemption (IDE) supplement with the U.S. Food and Drug Administration (FDA) requesting the inclusion of Arctic Circler Balloon in the “toolbox” approach in an Atrial Fibrillation study with the intention of treating an additional 20 patients. In the original IDE submission, Arctic Circler Balloon was not included as one of the three catheters in the toolbox. If approval is granted, CryoCath expects to start enrolling patients before the end of the year.
This application was made after the Company met with the FDA in September. At this meeting, the FDA advised it was amenable to CryoCath adding Arctic Circler Balloon to the toolbox. With respect to the final design of the pivotal study, it was agreed that CryoCath was to submit to the FDA an outline of the key protocol elements, including randomized versus single-arm study structure, defined clinical end-points, number of patients and the duration of the follow-up period.
In reviewing this IDE supplement, the FDA will consider some preliminary 3 month data on patients treated with this catheter in a European Feasibility study. These results showed that 13 out of 16 patients (81%) were AF-free. There was no evidence of any safety concerns - no stenosis, no thrombosis and no esophageal perforation - complications reported with radio-frequency (RF) ablation of the pulmonary veins.
Of the original 10 patients treated in Prague, 8 patients have returned for their 6-month follow-up for which non-monitored data is available. 1 of the 8 patients, who had early AF recurrence, was treated with a second cryoablation procedure and is AF free one month following. The other 7 patients are AF free after 6 months with 6 of the 7 patients off specified anti-arrhythmic drugs for AF treatment. The remaining 2 patients are AF free after 3 months, with their 6 month follow-up pending.
CryoCath also reported today 3-month chronic data from 24 patients treated at three U.S. centres using the originally contemplated tool box, Arctic Circler Linear, Freezor(R) Xtra and Freezor MAX. These results showed that 12 out of 24 (50%) patients experienced improvement - with 25% AF-free and 25% with reduced burden. As part of this feasibility study, the three participating centres employed different approaches to the ablation of the pulmonary veins. In the centre that employed an approach that most reflected the most successful technique developed in Europe, the success rate reached 70%, reflecting reported results from Europe. The safety profile from these 24 patients was similar to the Arctic Circler Balloon safety results with no evidence of any complications.
“Having attempted to treat some AF patients in the past with heat-based ablation, there is no question that the cryo-toolbox approach has unmatched potential with respect to clinical utility,” said Dr. Jim Irwin, St. Joseph’s Hospital in Tampa Bay, Florida. “Arctic Circler Linear was encouraging - it allowed me to safely treat patients that otherwise I would have been unable to - and with the exciting Arctic Circler Balloon results and its addition to the toolbox, my enthusiasm for this technology is higher than ever.”
“The combined safety data from these two studies in conjunction with our more than 600 commercial AF cases in Europe, is beginning to mount a pervasive argument regarding the feasibility of cryotherapy to safely and effectively ablate AF in the left-side of the heart,” said Steve Arless, President and CEO of CryoCath. “With no practical and safe solution available today and an untreated pool of more than 2.2 million patients growing at 400,000 new cases per year in the western world, the commercial opportunity for a safe, simple and effective solution for AF is without equal in the field of cardiac ablation.”
About Arctic Circler Balloon
The Arctic Circler Balloon catheter has been designed to overcome the three principal obstacles in providing a commercially viable ablation solution for treating AF - safety limitations, inappropriate chronic success rates, and lengthy/complex procedures. With regards to safety, all the clinical results from the prior use of cryoenergy in and around the pulmonary veins suggests that this energy source does not generate serious adverse events such as stenosis (narrowing of the vein), thrombosis (clot formation), and esophageal perforation - three complications that have been consistently reported with alternative heat-based ablation systems.
With respect to efficacy, early 3 and 6 month data suggests success rates well above traditional point-to-point RF ablation techniques.
With respect to simplifying the ablation of the pulmonary veins and reducing procedural times, the innovative balloon design allows the entire surface area of the encircling atrial and ostial tissue of the pulmonary vein to be ablated at one time, thereby reducing the number of lesions required. As well, the Balloon’s natural contours allow for simple and effective anatomical placement of the catheter balloon in the target region of the encircling atrial and ostial tissue of the pulmonary vein.
About CryoCath(R)
CryoCath - http://www.cryocath.com/ - is a medical technology company that leads the world in cryotherapy products to treat cardiovascular disease. With a priority focus on providing physicians with a complete solution of catheter and surgical products to treat cardiac arrhythmias, CryoCath has multiple products approved in the U.S., across Europe and several ROW countries. The Company is developing additional products to expand its pipeline of products to treat cardiac arrhythmias and has development projects for the treatment of cardiac ischemia (angina) and peripheral arterial disease (PAD).
This press release includes “forward looking statements” that are subject to risks and uncertainties. For information identifying legislative or regulatory, economic, climatic, currency, technological, competitive and other important factors that could cause actual results to differ materially from those anticipated in the forward looking statements, see CryoCath’s Annual Report under the heading Risks and Uncertainties in the Management’s Discussion and Analysis section.
CryoCath Technologies Inc.
CONTACT: Visit our website at http://www.cryocath.com/, or contact:Steven G. Arless, President & CEO, CryoCath Technologies Inc.,Tel: (514) 694-1212 ext. 224, sarless@cryocath.com; Mike Polonsky,Investor Relations, Tel: (416) 815-0700 ext. 231, Fax: (416) 815-0080,mpolonsky@equicomgroup.com