Medtronic has obtained CE Mark approval for its NC Euphora noncompliant balloon dilatation catheter, which the company states provides improved deliverability and controlled growth for challenging coronary angioplasty procedures.
With CE Mark approval, the NC Euphora balloon catheter is now available in Europe and other countries outside of the US that recognise the status.
Medtronic's NC Euphora balloon dilatation catheter helps ensure implanted drug-eluting stents are fully apposed so that they can properly transfer therapy to the artery wall, reducing the risk for restenosis and stent thrombosis related to under-expansion.
The device features PowerTrac technology, optimised tapered tip design, durable and flexible LIGHT (low- inflation growth, high track) balloon material.
PowerTrac technology provides superior deliverability through tight lesions and requires less force to track through tortuous anatomy.
Optimised tapered tip design and low lesion entry profile of the device 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.
LIGHT balloon material provides high-pressure capability, which enables the device to expand consistently within the stent area at a rated burst pressure of up to 20 atmospheres without bursting.
NC Euphora provides superior growth profile with 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.
Conquest Hospital Hastings and Eastbourne District General Hospital East Sussex Healthcare NHS Trust consultant interventional cardiologist and pre-clinical researcher for the NC Euphora balloon Dr Robert Gerber said that when using a noncompliant balloon, deliverability and re-cross are important characteristics, especially when faced with challenging coronary anatomy.
"The NC Euphora balloon was designed to meet these demands and provide reliable performance with no tradeoffs in the moment that we need it most," Dr Gerber said.
Image: Medtronic's world headquarters in Minneapolis, US. Photo: courtesy of Medtronic, Inc.