St. Jude Okayed on Heart-rhythm Devices

St. Jude Medical announced that it has been approved for U.S. and European sales of two new cardiac rhythm-management products.

The St. Paul, MN-based device manufacturer said it got FDA approval and the European CE Mark approval for its Reflexion Spiral Variable Radius Mapping Catheter — designed to deflect in both directions — and a faster, smaller EnSite System workstation computer, which provides three-dimensional models of the heart to help doctors diagnose arrhythmia.

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.