Healthcare Industry News: CryoBalloon
News Release - July 15, 2009
Medtronic Clinical Trial Evaluating the Industry's First Cryoballoon Technology Designed for Paroxysmal Atrial Fibrillation Completes Follow UpCatheter System Designed to Treat Most Common Heart Arrhythmia with More than 7 Million Sufferers Worldwide
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ) today announced completion of a 12-month follow up in the STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial evaluating the first CryoBalloon catheter technology designed to treat paroxysmal atrial fibrillation – the Medtronic Arctic Front(R) CryoAblation Catheter System. Atrial fibrillation (AF) is the most common arrhythmia affecting more than 3 million Americans and 7 million people worldwide.¹ After the study data are analyzed and filed with regulatory authorities, the results will be shared at an upcoming medical meeting. The system is approved for use in Europe, Australia and Hong Kong and is under investigational use in the United States.
The Arctic Front system uses cryoablation, or freezing, to ablate heart tissue between the pulmonary veins and the left atrium. The goal of an ablation is to stop the arrhythmia at the source. During cryoablation, a coolant is released into the catheter’s balloon causing the balloon to freeze and ablate the heart tissue. Freezing helps the balloon maintain contact with the tissue being ablated.
“This catheter is designed to allow physicians to more efficiently and easily ablate than with a single tip ablation procedure,” said Kevin Wheelan, M.D., chief of staff at Baylor Heart and Vascular in Dallas and investigator in the STOP-AF trial. “In this trial, the CryoBalloon's stability simplified the process for these types of cardiac ablation procedures.”
“Arctic Front is one of the tools in Medtronic’s growing AF Solutions portfolio,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “Our goal is to develop and deliver breakthrough therapies that help physicians to effectively treat AF patients faster, safer, easier, and with more predictable procedure times.”
Medtronic recently acquired CryoCath LP and Ablation Frontiers, LLC, which along with its existing EP Systems diagnostic and RF ablation catheters, collectively form Medtronic’s AF Solutions division.
About the Medtronic Arctic Front CryoAblation Catheter System
The Medtronic Arctic Front CryoAblation Catheter System technologies used in the STOP-AF trial include:
- The Arctic Front CryoBalloon catheter, which inflates and fills with coolant to ablate between the pulmonary veins and the left atrium;
- The FlexCath(R) Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium;
- The Freezor(R) MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations; and
- The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheter during a cryotherapy procedure.
This pivotal trial is studying the safety and efficacy of the Medtronic Arctic Front CryoAblation Catheter System in paroxysmal AF patients as compared to drug therapy. Patients were randomized to receive ablation therapy or commonly used drug treatments. For every three patients enrolled, approximately two received an ablation and one was randomly assigned to the drug therapy group. Twenty-five U.S. and Canadian centers enrolled 245 patients who were followed for at least 12 months after the ablation procedure. Results will be submitted in consideration for U.S. Food and Drug Administration (FDA) approval for the Medtronic Arctic Front CryoAblation Catheter System.
About Atrial Fibrillation
Atrial fibrillation is an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart. Paroxysmal AF occurs when the irregular rhythm starts and stops suddenly on its own. Untreated AF patients have a two to seven times higher risk of stroke.2 Atrial fibrillation causes inefficient pumping of the heart and can lead to other rhythm problems as well as chronic fatigue and heart failure.
Caution: The Medtronic Arctic Front CryoAblation Catheter System is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 24, 2009. Actual results may differ materially from anticipated results.
1 Millennium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1.
2 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.
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