balloon shape allow for simple and effective anatomical placement of the catheter balloon in the target region of the encircling atrial tissue of the pulmonary veins. with an annual incidence of 160,000 new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. 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).
CryoCath Technologies Inc Reports Positive Data At Atrial Fibrillation Conference
With respect to the live case, the 54 year old female patient was diagnosed with paroxysmal AF and had previously failed one drug treatment. The case resulted in an acute success where all four Air Max 90 Ultra Superfly Tinker
The Arctic Front catheter has been designed to overcome the three principal obstacles in providing a commercially viable ablation solution for treating AF safety limitations, inadequate 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, data from a 20 patient European study using Arctic Front 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 tissue of the pulmonary veins to be ablated at one time, thereby reducing the number of lesions required. As well, the natural contours of the catheter's Nike Air Max 90 Hyperfuse 2015
MONTREAL, Jan. 16 /PRNewswire FirstCall/ the global leader in cryotherapy products to treat cardiovascular disease, today announced that Dr. Douglas Packer, from Mayo Clinic, presented additional data from the feasibility stage of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) investigational device exemption Nike Air Max 90 Ultra Se Black
Secondly, he reported on early data from 15 patients treated in the feasibility stage of the STOP AF trial who have now reached a minimum 3 month follow up point. Thirteen patients are now AF free (87%), one has been retreated, and one other scheduled to be retreated (one retreatment is consistent with the study's protocol). There were no reported permanent serious device related adverse events such as stenosis, stroke, esophageal fistula or permanent phrenic nerve injury.
Dr. Packer reported data on two sets of Arctic Front patient data. Firstly, he reviewed the 12 month data from the original 20 patient European trial which saw 84% of patients AF free (a further 10% or 2 more patients had significant reductions in AF burden and have conditions that do not warrant re treatment and are considered clinically successful).
This press release includes "forward looking statements" that are subject to risks and uncertainties. Nike Air Max 90 Ultra Se Grey 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.
veins were isolated using the Arctic Front Balloon catheter alone. No safety concerns or adverse events were noted.
The Arctic Front balloon catheter is now available in Europe through a controlled beta launch. More than 75 patients have been treated there to date with a very encouraging 97% acute success rate. A more extensive rollout of this product is expected in the first half of calendar 2006. The company also anticipates starting the pivotal stage of the IDE study in calendar Q1.
Arctic Front is the world's first balloon cryo catheter designed to treat AF. The size and shape of its balloon safely and quickly creates a band of non conducting tissue. These transmural lesions block aberrant electrical signals, preventing future AF episodes. data, further positions Arctic Front as the most clinically promising solution for the treatment of AF," said Steve Arless, President and CEO of CryoCath. "Moreover, the early commercial enthusiasm and physician feedback from Europe further suggests that Arctic Front's commercial potential represents a significant business opportunity for CryoCath."
The ablation procedure was performed by Dr. Vivek Reddy of MGH, who used Arctic Front to isolate the pulmonary veins. The live case, which kicked off the conference, was viewed by more than 1000 attendees, composed of Physicians and industry representatives via satellite, and was moderated by Dr. Jeremy Ruskin, Chief of Electrophysiology at MGH.
About Arctic Front
The feasibility stage of the STOP AF study has enrolled 15 patients in total at the Mayo Clinic in Rochester, Minnesota and Massachusetts General Hospital (MGH) in Boston, Massachusetts.
"The data presented at this conference is consistent with what we've already seen in Europe. It shows unprecedented efficacy, coupled with a strong safety profile," says Jean Pierre Desmarais, Chief Scientific Officer at CryoCath. "These results reinforce our belief that cryotherapy delivered by Arctic Front is the ideal way to treat AF."
(IDE) study using the Company's proprietary Arctic Front catheter to treat Atrial Fibrillation (AF). The data was presented at the preeminent 11th Annual International Boston Atrial Fibrillation Symposium, the only global conference focused solely on the treatment of AF.
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