FDA clears Medtronic’s NC Euphora coronary balloon

11 September 2014 (Last Updated September 11th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Medtronic's NC Euphora noncompliant balloon dilatation catheter.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Medtronic's NC Euphora noncompliant balloon dilatation catheter.

The new device features PowerTrac technology, which claims to offer better deliverability through challenging lesions.

Its optimised tapered tip design and low lesion entry profile of the device improves flexibility and allows for reliable stent re-cross when traversing long and challenging lesions.

The balloon material included in the device offers high-pressure capability, allowing NC Euphora to expand consistently within the stent area at a rated burst pressure of up to 20 atmospheres without bursting.

"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 company 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 to facilitate transfer of the drug to the artery wall.

Piedmont Heart Institute in Atlanta chief scientific officer and interventional cardiology director David Kandzari said: "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.

"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 offers various features to the clinicians such as superior deliverability; excellent re-cross; durability; low growth profile; and enhanced packaging.

Non-compliant (NC) balloons are specifically designed for post-stent dilatation to ensure complete expansion of the stent against the arterial wall. An under-expanded stent is associated with higher restenosis rates, as well as stent thrombosis.

Piedmont Heart Institute cath lab staff member Chad Dupree said: "The advanced features of NC Euphora demonstrate that not all balloon catheters are the same.

"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."