Medtronic Releases NC Euphora Noncompliant Balloon Dilatation Catheter

Minneapolis, Minn.-based Medtronic Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its NC Euphora noncompliant balloon dilatation catheter. The company is launching the device immediately.

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. Stent under-expansion has been defined as a major risk factor for both artery re-narrowing, or restenosis, and the potential formation of blood clots, known as stent thrombosis. Postdilatation with noncompliant balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.

“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,” said David Kandzari, M.D., director of Interventional Cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, Ga. “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 NC Euphora balloon catheter feature Powertrace technology, intended to facilitate deliverability through challenging lesions and requires less force to track through tortuous anatomy. An optimized tapered tip design and low lesion entry profile is reported to improve flexibility and allows for reliable stent re-cross when traversing long, challenging lesions so that the balloon does not catch on a strut when passing through a deployed stent. The balloon is designed to be able to exand constantly within the stent area at a rated burst pressure of up to 20 atmospheres.

“The advanced features of NC Euphora demonstrate that not all balloon catheters are the same,” said Chad Dupree, RT cath lab staff member at the Piedmont Heart Institute. “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.”