CRYOCATH REPORTS STRONG AF RESULTS.
Of the 16 patients who have now reached the 6-month follow-up point, 13 are AF-free, with 11 off specific anti-arrhythmic drugs. Of the three patients who were technically deemed "treatment failures", one was retreated and is AF-free; and the other two are both off drugs, have had a significant reduction in burden, and have conditions that do not warrant re-treatment and are considered clinically successful. There have been no device related serious adverse events such as stenosis, stroke or esophageal perforation. There were two reports of asymptomatic transient phrenic nerve palsy with no clinical sequalae. The first patient has fully recovered while the second patient has almost fully recovered at six-month follow-up.
"The preliminary results from the European clinical study using the first generation Arctic Circler Balloon are promising. Most encouraging is the system's safety and efficacy profile," said Dr. Reddy. "After two important modifications, better maneuverability and a larger balloon radius, I believe this technology will prove to be an exciting new option to treat AF."
The 20-patient study was conducted at two European centres: Homalka Hospital in Prague, under the direction of Dr. Vivek Reddy and Dr. Petr Neuzil of the Czech Republic; and at the Kerkoff Klinik, Germany, under the direction of Dr. H. F. Pitschner.
"In designing Arctic Circler Balloon, we had three mission-critical objectives that we felt had to be achieved if this, or any AF product, were to have clinical success. It had to have an excellent safety profile, it must reach high efficacy levels and it must accommodate a simple and relatively quick procedure," said Jean-Pierre Desmarais, Chief Scientific Officer, CryoCath. "These results today and the positive feedback from the physicians strongly suggest that Arctic Circler Balloon meets all three objectives. Moreover, with our second generation design incorporating a larger balloon and advanced steerability, we can only improve upon this already exciting start."
CryoCath intends to file for the European CE Mark during the first quarter of calendar 2005 and if granted, launch in Europe in the second quarter of calendar 2005. Enrolment in an Investigational Device Exemption study is expected to begin sometime in the first quarter of calendar 2005 upon approval by the FDA of the tool-box approach that will now include Arctic Circler Balloon, Arctic Circler Linear and Freezor MAX.
"It has always been our vision to position CryoCath with its catheter and surgical product portfolio as the number one company in the world for the treatment of AF," said Steve Arless, president and CEO of CryoCath. "These Arctic Circler Balloon results take us one step closer to that reality."
About Arctic Circler Balloon
The Arctic Circler Balloon catheter has been designed to overcome the four principal obstacles in providing a commercially viable ablation solution for treating AF - safety limitations, inappropriate chronic success rates, lengthy/complex procedures and consistent and reproducible outcomes. 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. As a result, procedures are expected to be completed in less than 2.5 hours (skin-to-skin).
About Atrial Fibrillation
AF, described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 2.2 million patients in the U.S. 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. If left untreated, it can lead to heart failure and death.
CryoCath -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).
For more information, call 514/694-1212, ext. 224 or visit http://www.cryocath.com.
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|Publication:||Biotech Equipment Update|
|Date:||Mar 1, 2005|
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