FDA Clears Medtronic's Euphora Semicompliant Balloon Dilatation Catheter
Medtronic has received the U.S. Food and Drug Administration (FDA) clearance for its Euphora Semicompliant Balloon Dilatation Catheter, a pre-dilatation therapy used during a stent implantation to reopen a narrowed coronary artery caused by plaque buildup.
The first patient case with the catheter was recently performed by Dr. James T. DeVries, director of Endovascular Intervention and associate director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, NH.
"We at Dartmouth-Hitchcock Medical Center are pleased to have been chosen as the U.S. 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," said DeVries.
Pre-dilatation with a semicompliant balloon helps physicians determine lesion characteristics, stent selection and facilitates stent access to the lesions - a crucial step for patients with challenging lesions.
The Euphora device features several new design advancements including:
- Delivery system with PowerTrac technology to provide superior deliverability (compared to major competitors) through challenging lesions. This enhanced pushability comes from a re-designed shaft technology first introduced with the Medtronic NC Euphora Noncompliant Balloon Dilatation Catheter in September 2014
- Ultra-slim balloon material, a tapered proprietary inner shaft design and an optimized mini-wrap to reduce the wall thickness of the balloon and contribute to the extremely low crossing profile
- Improved insertion and retraction force to enhance navigation to lesion sites when using the Kissing Balloon Technique
- Packaging enhancements for quicker and easier identification by cath lab staff due to new product labeling and EZ Pull Corners, as well as reduced box size for optimal shelf storage
Source: Medindia