FDA Cleared for U.S. Launch: Medtronic’s Euphora™ Semicompliant Coronary Balloon

Having gained U.S. FDA 510(k) clearance for its Euphora™ Semicompliant Balloon Dilatation Catheter, Medtronic is now readying for launch of the pre-dilatation therapy, which is used during a stent implantation to reopen a narrowed coronary artery caused by plaque buildup.

Background

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. Medtronic’s Euphora Semicompliant Balloon Catheter features a new delivery system with PowerTrac™ technology. This enhanced pushability comes from a re-designed shaft technology, first introduced with the Medtronic NC Euphora Noncompliant Balloon Dilatation Catheter in September 2014­. ­The company claims this provides superior deliverability through challenging lesions. 

Another key feature is the 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. It also boasts improved insertion and retraction force to enhance navigation to lesion sites when using the Kissing Balloon Technique (two balloons inflated simultaneously in bifurcating anatomy).

The Euphora semicompliant balloon received CE mark in December 2014.

The first patient case with the Euphora Semicompliant Balloon Catheter was recently performed by James T. DeVries, MD, FACC, FSCAI, director of Endovascular Intervention and associate director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Physician comments

“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.”

Company comments 

“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.”

Source: Medtronic, plc

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