FDA Clears Medtronic’s Euphora Semicompliant Balloon Dilatation Catheter

Medtronic plc has received U.S. Food and Drug Administration (FDA) 510(k) clearance and launched 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 Euphora Semicompliant Balloon Catheter recently was performed by James T. DeVries, M.D., director of Endovascular Intervention and associate director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

“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, stent selection and facilitates stent access to the lesions, which is a crucial step for patients with challenging lesions.

The Euphora Semicompliant Balloon Catheter features several new design advancements including:
• Delivery system with PowerTrac technology to provide superior deliverability (compared to major competitors)[i] 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 corners designed to be pulled easily, as well as reduced box size for optimal shelf storage.

“With the addition of the Euphora semicompliant balloon we are able to provide physicians with one of the most robust and best-in-class interventional product portfolios available on the market,” said Jason Weidman, vice president and general manager of the Coronary & Renal Denervation business in Medtronic’s Coronary & Structural Heart division. “This launch delivers on our strategy of introducing a breadth of premium products, and exemplifies our continued commitment to deliver innovative and differentiated technologies that address the needs of cath lab professionals around the world.”

The Euphora semicompliant balloon received CE mark in December 2014, and expands Medtronic’s interventional portfolio of medical devices across the firm’s Coronary, Renal Denervation and Transcatheter Aortic Valve Replacement product lines, and is one of 12 new product introductions planned in the next two years.  

In an effort to increase education and peer-to-peer engagement among cath lab professionals, Medtronic will launch Cath Lab Connect, an informational portal and community website dedicated to cath lab nurses and technicians. The website, which will go live this month, 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.

Medtronic is headquartered in Dublin, Ireland.