CryoCath Technologies Treats First Three Patients of Multi-center Investigational Device Exemption in the USA
Kirkland, Québec, Canada - January 12, 2000 - CryoCath Technologies Inc., the world leader in catheter cryoablation systems, today announced that they have treated, with a Freezor™ cryocatheter, their first three patients enrolled in the multi-center Investigational Device Exemption (IDE) human clinical study in the USA, which follows a 40-patient study in Canada. The ablation procedure resulted in the acute termination of their arrhythmia and no complications were noted in any of the three patients. The patients will be monitored for a period of 6 months to establish the safety and efficacy of the cryoablation system.
The procedures took place at the University of Oklahoma Health Sciences Center, Cleveland Clinic Foundation, and Duke University Medical Center, where the patients were treated for Supraventricular Tachycardia (SVT).
In all three cases, the investigators were able to proceed with cryomapping the target area, prior to proceeding with the ablation. Cryomapping is a potentially unique feature of the technology, where the targeted area is cooled down to intermediate temperatures to reversibly arrest electrical conductivity in order to confirm the appropriateness of the proposed ablation site. Part of the study aims at establishing the feasibility and safety of this unique feature.
"Investigators at all three sites have shown excitement about this technology, given their initial experience, and are looking forward with enthusiasm to continuing the study" stated Steven G. Arless, President & CEO of CryoCath Technologies.
About Medtronic CryoCath
CryoCath is a therapeutic medical devices company and the world leader in catheter-based cryotherapy technology. Established in 1995 and employing over 60 highly skilled professionals, the Company has successfully overcome challenges to the delivery of cryoenergy in a safe, effective, minimally invasive manner. The use of cold temperatures to treat diseased tissue areas has long been proven and, more importantly, has a potentially much higher safety profile than heat-based alternatives.
Medtronic CryoCath Products
A second product currently in pre-clinical trials is a cryocatheter for the treatment of post angioplasty restenosis.
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