Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its NC Euphora device, a balloon catheter designed to make sure a drug-eluting coronary stent is properly seated after implantation.
The NC Euphora début is part of the dozen new products Medtronic plans to launch over the next 2 years, according to a press release.
"When developing NC Euphora, insights from the entire cath lab team were gathered and addressed to ensure it meets the current needs of cath lab professionals in device design and performance," Dr. David Kandzari, of the Piedmont Heart Institute in Atlanta, said in prepared remarks. "The advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures."
"The advanced features of NC Euphora demonstrate that not all balloon catheters are the same," added Piedmont Heart’s Chad Dupree. "The cath lab team recognizes that balloon catheters are a key component of the procedure, and availability of a device that optimizes stent deployment presents a key opportunity that we have to achieve procedural success."
Medtronic also said it’s launched a website for catheterization lab nurses and technicians, Cath Lab Connect, at www.cathlabconnect.com.