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Cryoablation’s Superior Safety Profiled at Major Cardiology Conference

Supports use of Cryoenergy in AF, VT and SVT Markets

Anaheim, California, USA - October 13, 2001 - American Heart Association Conference - Two leading cardiology research centers presented technical abstracts yesterday detailing the advantages of cryoenergy over radiofrequency-based (RF) treatments in reducing both thrombogenicity (clot formation) and the risk of coronary artery stenosis (closing or narrowing of the vessel lumen) when treating cardiac arrhythmias. These two animal studies from The Montreal Heart Institute (represented at the conference by Patrick Chauvet of CryoCath Technologies) and The University of Oklahoma Health Sciences Center, used Freezor^TM technology from CryoCath Technologies, the world leader in cryotherapy products to treat cardiovascular disease, to generate their findings.

“These papers from the lead researchers at two of North America’s most prestigious healthcare centers underscore the growing consensus that cryoenergy technology may offer a safer, and more effective treatment for many cardiac conditions,” said Steven G. Arless, President and CEO of CryoCath. “This evidence positions cryoablation as the product of choice for the explosive growth markets of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT), and it suggests that cryoablation is a better tool for the current $250 million SVT market as well.”

Both papers based their conclusions on observations made in animal models. Dr. Marc Dubuc of The Montreal Heart Institute demonstrated that RF treatment was six times more likely to generate clot formation compared to cryotreatment. Moreover, the clots created by RF were on average substantially larger (over ten times greater) than those related to cryotreatment.

Cryoenergy’s superior safety profile (reduced thrombosis, stenosis and collateral damage) opens the door for more aggressive ablation particularly on the left side of the heart where 75% of all arrhythmias originate. Dr. Dubuc’s study demonstrated that cryoenergy reduces the risk of producing a clotting event, which can cause severe complications, including stroke.

The study from the University of Oklahoma (Dr. Hiroshi Nakagawa and Dr. Warren Jackman) showed that cryoenergy can be effectively delivered within key cardiac veins (coronary sinus (CS) or middle cardiac vein (MCV)) to potentially treat common arrhythmia sites. Importantly, cryoenergy was found to be significantly less likely to cause stenosis or damage to the adjacent arteries, which is the limiting factor for ablation with conventional Radiofrequency current.

left side of the heart, cryoablation’s advantages represent a significant competitive advantage and may enable CryoCath to dominate an expanding ablation market opportunity of approximately $1 billion,” said Mr. Arless.

Both studies are available here. 1 2



CryoCath’s growth strategy has seen the Company work closely with cardiology opinion leaders around the world as it seeks to demonstrate the significant human and financial benefits of cryotechnology. CryoCath conducted a highly successful launch in Europe during 2001; many leading European cardiology centers now use Freezor technology. As the Company prepares to enter the North American market upon regulatory approval, it intends to leverage the experience gained in Europe into successful Canadian and U.S. launches in 2002 and 2003 respectively. CryoCath expects to complete its pivotal U.S. IDE study by Q1, 2002, with enrolment now more than 50% complete.

About Medtronic CryoCath

CryoCath is a medical technology company that leads the world in creating minimally invasive, catheter-based cryotherapy products to treat cardiovascular disease across three broad indications: tachyarrhythmia (CryoCath’s primary focus), ischemia and restenosis. CryoCath has already successfully launched its first product, the Freezor CryoAblation System, in Europe and is developing additional products to expand its pipeline of products to treat tachyarrhythmia. As well, it is also involved in the co-development and commercialization of the SurgiFrost^TM cryosurgical probe to treat AF. CryoCath expects to achieve U.S. commercialization in 2002 and for Freezor in 2003.

Medtronic CryoCath Products
CryoCath's initial product is a cardiac cryoablation catheter system intended for use in the treatment of heart arrhythmias (irregular and rapid heartbeats). There are currently no ideal catheter ablation solutions to treat up to 75% of all arrhythmias worldwide. CryoCath's system has the potential to treat nearly every known arrhythmia, including atrial fibrillation. The Company is also developing specialized cryocatheter treatment systems for two additional pervasive cardiovascular diseases: post-angioplasty restenosis and cardiac ischemia.

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