Medtronic Announces FDA Clearance, Launch of Balloon Dilation Catheter

Medtronic Tuesday announced the 510(k) clearance and U.S. launch of its Euphora seimompliant balloon dilation catheter, a pre-dilatation therapy used during a stent implantation to reopen a coronary artery narrowed by plaque buildup.

Pre-dilatation therapy with a semicomplaint balloon helps physicians determine lesion characteristics, select a stent, and ease stent access to the lesions, which is a critical step for patients with challenging lesions, the Irish devicemaker said.

The Euphora received a CE mark in December 2014. Medtronic said it is one of 12 planned product releases over the next two years.

Additionally, Medtronic said it will launch “Cath Lab Connect” a website dedicated to cath lab nurses and technicians.

It will feature educational resources, information on upcoming events and conferences, industry news and a forum for members to discuss relevant topics. — Kellen Owings