FDA clearance for Medtronic NC Euphora coronary balloon


Medtronic has announced the US Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora noncompliant balloon dilatation catheter. The new device will be featured for the first time in the United States at the Medtronic booth at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, DC, USA).

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,” says David Kandzari, director of Interventional Cardiology and chief scientific officer, at the Piedmont Heart Institute in Atlanta, USA. “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 was designed for uncompromising performance to provide clinicians with several valuable features, including:

  • Superior Deliverability: PowerTrac technology provides superior deliverability through challenging lesions and requires less force to track through tortuous anatomy.
  • Excellent Re-cross: An optimised tapered tip design and low lesion entry profile improves 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.
  • Durability: Strong and flexible proprietary balloon material provides high pressure capability, which enables NC Euphora to expand consistently within the stent area at a Rated Burst Pressure (the maximum pressure that the balloon can be repeatedly inflated in a safe manner) of up to 20 atmospheres without bursting.
  • Low Growth Profile: Significantly low radial growth to reduce unwanted vessel expansion and low longitudinal growth beyond the stent length to minimise damage to the surrounding healthy artery.
  • Enhanced Packaging: Environmentally friendly packaging and a reduced box size that has a smaller footprint on congested shelves and a broad size range labelled clearly and intuitively. 

“The advanced features of NC Euphora demonstrate that not all balloon catheters are the same,” says Chad Dupree, cath lab staff member at the Piedmont Heart Institute. “The cath lab team recognises that balloon catheters are a key component of the procedure, and availability of a device that optimises stent deployment presents a key opportunity that we have to achieve procedural success.”