Medtronic Balloon Catheter Gets CE Mark, Europe Debut

Medtronic has announced that it has received CE Mark approval for its NC Euphora Balloon Catheter and that the device is now available in Europe and other countries that recognize the CE Mark.

A specialized device called a noncompliant balloon dilatation catheter, the NC Euphora is deployed following drug-eluting stent implantation to reopen the narrowed artery. After being maneuvered into position, the 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.

According to Medtronic's literature, stent under-expansion has been defined as a major risk factor for both restenosis and stent thrombosis adverse events. The company says that post-dilatation with NC balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.

The new device features Medtronic's PowerTrac technology, which is said to provide superior deliverability through tight lesions and require less force to track through tortuous anatomy. Its design includes an optimized tapered tip design and low lesion entry profile to improve flexibility and allow 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 low inflation growth balloon material provides high pressure capability, enabling 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. Further, low radial growth reduces unwanted vessel expansion and low longitudinal growth beyond the stent length minimizes damage to the surrounding healthy artery.

"When using a noncompliant balloon, deliverability and re-cross are important characteristics, especially when faced with challenging coronary anatomy," said Robert Gerber, PhD, consultant interventional cardiologist, Conquest Hospital Hastings and Eastbourne District General Hospital East Sussex Healthcare NHS Trust, and pre-clinical researcher for the NC Euphora balloon. "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."

The Fridley, MN-based Medtronic offers a broad range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company says it strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Stephen Levy is a contributor to Qmed and MPMN.