Jan. 12, 2007 — The FDA has cleared St. Jude Medical’s Reflexion Spiral Variable Radius Mapping Catheter and a faster, smaller EnSite System workstation computer.
The products are being debuted today and Saturday at the Boston Atrial Fibrillation Symposium a meeting of leading electrophysiologists in the field of arrhythmia and atrial fibrillation (AF) management from around the world.
The Reflexion Spiral Variable Radius features a circular loop at the tip that expands from 15 mm to 25 mm to fit a variety of patient anatomies. It is the only variable radius circular mapping catheter available with bi-directional deflection, which provides enhanced versatility for complex left atrial procedures. It also features the proprietary ComfortGrip handle to give physicians improved comfort and control during electrophysiology (EP) procedures.
"The ability of the catheter to deflect in both directions is a very useful benefit, and the handle proved extremely comfortable and easy to use," said Andrea Natale, M.D., Cleveland Clinic, one of the first physicians to use the product.
The EnSite System provides highly detailed, 3-D cardiac models that help physicians diagnose and treat many arrhythmias, including AF. The system is now available with a new computer, featuring twin dual-core processors for enhanced processing speed. Many of the most complex processing and image rendering times have been reduced by up to 80 percent, allowing clinicians to obtain, display and analyze information faster.