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Coronary balloon catheter nets FDA clearance

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Medtronic has announced today that its NC Euphora noncompliant balloon dilatation catheter has received FDA 510(k) clearance.

According to a press release from the manufacturer, the new balloon dilatation catheter features enhanced deliverability with the PowerTrac technology; a tapered tip and low lesion entry profile to improve flexibility and allow for stent re-cross in long, challenging lesions; strong and flexible proprietary balloon material; low growth profile; and environmentally friendly packaging.  

David Kandzari

“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,” David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, said in the press release. “The advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures.”

NC Euphora is the latest in a series of 12 new product introductions Medtronic plans during the next 2 years, the manufacturer stated in the release.

In other news, Medtronic also announced the launch of the “Cath Lab Connect” website, which it said will provide educational resources, programs and webinars, as well as opportunities for networking and best-practice sharing among cath lab professionals.