Medtronic (NYSE:MDT) today said the FDA cleared its Euphora semicompliant balloon dilation catheter, and the company wasted no time in getting the pre-stenting device on the U.S. market.
Dr. James DeVries of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., performed the 1st commercial case to use the Euphora device, Medtronic said. It’s designed to re-open a clogged coronary artery to prepare the lesion for a stent, the company said.
"With the addition of the Euphora semicompliant balloon we are able to provide physicians with 1 of the most robust and best-in-class interventional product portfolios available on the market," vice president Jason Weidman said in prepared remarks. "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."
Medtronic launched the the Euphora semicompliant device in Europe last February after it won CE Mark approval in December 2014.
Pre-dilation allows cardiologists to asses the lesion and select the proper stent to treat it, the company said, and also helps improve access in complex cases.
Medtronic also said it’s planning a launch this month for a new portal for catheterization lab personnel, called "Cath Lab Connect," aiming to create a forum for sharing best practices, educational resources and industry news.