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Medtronic receives FDA approval for NC Euphora

Medtronic has received 510(k) approval from the US Food and Drug Administration (FDA) for its NC Euphora Noncompliant Balloon Dilatation Catheter.

The NC Euphora features PowerTrac technology, which offers better deliverability through challenging lesions and its tapered tip design, as well as low lesion entry profile improves flexibility and allows for reliable stent re-cross when traversing long and challenging lesions.

In addition, the balloon material offers high pressure capability, which allows NC Euphora to expand consistently within the stent area at a Rated Burst Pressure of up to 20 atmospheres without bursting.

Medtronic said that following drug-eluting stent implantation to reopen a narrowed artery, a noncompliant balloon is inflated with high pressure to ensure that the stent is fully apposed in order to facilitate transfer of the drug to the artery wall.

Atlanta’s Piedmont Heart Institute interventional cardiology director and chief scientific officer David Kandzari said the advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures.

"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," Kandzari added.

The company will showcase the new device at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington DC, which will take place between 13-17 September.