FDA Clears Medtronic's Euphora Semicompliant Coronary Balloon

May 5, 2015—Medtronic plc announced US Food and Drug Administration 510(k) clearance and the United States launch of the Euphora semicompliant balloon dilatation catheter. The device received European CE Mark approval in December 2014. 

James T. DeVries, MD, recently performed the first patient case with the Euphora device. Dr. DeVries is Director of Endovascular Intervention and Associate Director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire. In Medtronic’s press release, Dr. DeVries commented, “We at Dartmouth-Hitchcock Medical Center are pleased to have been chosen as the United States launch site for the Medtronic Euphora balloon. This continued access to new technology is essential to help our patients in the ongoing battle against coronary artery disease.”
 
According to Medtronic, predilatation with a semicompliant balloon helps physicians determine lesion characteristics and stent selection, and also facilitates stent access to the lesions. The Euphora semicompliant balloon catheter’s new design features include a delivery system with the company’s PowerTrac technology for superior deliverability through challenging lesions. This enhanced pushability comes from a redesigned shaft technology first introduced with the Medtronic NC Euphora noncompliant balloon dilatation catheter in September 2014.

The device is composed of ultra-slim balloon material, a tapered inner shaft design, and an optimized miniwrap to reduce the wall thickness of the balloon and contribute to the extremely low crossing profile. Improved insertion and retraction force enhances navigation to lesion sites when using the kissing-balloon technique.  Additionally, packaging enhancements such as new product labeling and EZ Pull corners allow for quicker and easier identification by catheterization lab staff.
  
Medtronic also announced it will launch Cath Lab Connect, an informational portal and community website dedicated to catheterization lab nurses and technicians. The website will go live this month at www.cathlabconnect.com.