May 8, 2015 — Medtronic plc announced U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. launch of the Euphora Semicompliant Balloon Dilatation Catheter. Euphora is 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 Euphora Semicompliant Balloon Catheter was recently performed by James T. DeVries, M.D., FACC, FSCAI, director of endovascular intervention and associate director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
“We at Dartmouth-Hitchcock Medical Center are pleased to have been chosen as the U.S. launch site for the Medtronic Euphora balloon,” said DeVries. “This continued access to new technology is essential to help our patients in the ongoing battle against coronary artery disease.”
Pre-dilatation with a semicompliant balloon helps physicians determine lesion characteristics and stent selection, and facilitates stent access to the lesions – a crucial step for patients with challenging lesions.
The device features several new design advancements including:
- Delivery system with PowerTrac technology to provide 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;
- 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; and
- 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.
In an effort to increase education and peer-to-peer engagement among cath lab professionals, Medtronic also announced it will launch “Cath Lab Connect,” an informational portal and community website dedicated to cath lab nurses and technicians. The website, which will go live in May, will feature educational resources for cath lab professionals, information about upcoming events and conferences, industry news, as well as a forum for members to connect and discuss relevant topics or share best practices.
For more information: www.medtronic.com
June 13, 2024 
