Medtronic's NC Euphora Coronary Balloon Approved and Launched in Europe

May 20, 2014—Medtronic, Inc. announced European CE Mark approval and the commercial launch of its noncompliant (NC) Euphora balloon dilatation catheter, which is now available in Europe and other countries that recognize the CE Mark. 

The company is introducing the NC Euphora balloon catheter at the EuroPCR 2104 congress in Paris, France, on May 20–23. The device is not yet available in the United States.

The company stated that the device’s features include Medtronic’s PowerTrac technology, which provides deliverability through tight lesions and tortuous anatomy. An optimized tapered tip design and low lesion entry profile improve flexibility and allows for reliable stent recross when traversing long, challenging lesions so that the balloon does not catch on a strut when passing through a deployed stent. Strong, durable, and flexible LIGHT (Low Inflation Growth, High Track) balloon material provides high-pressure capability to enable the NC Euphora to expand consistently within the stented area at a rated burst pressure of up to 20 atm. The device’s growth profile provides significantly low radial growth to reduce unwanted vessel expansion and low longitudinal growth beyond the stent length to minimize damage to the surrounding healthy artery. 

According to Medtronic, after drug-eluting stent implantation to reopen the 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. The company noted that stent underexpansion has been defined as a major risk factor for both restenosis and stent thrombosis adverse events. Postdilatation with NC balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.

Robert Gerber, MD, a preclinical researcher for the NC Euphora balloon, commented in Medtronic’s press release, “When using a noncompliant balloon, deliverability and recross 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 is a consultant interventional cardiologist at Conquest Hospital Hastings and Eastbourne District General Hospital East Sussex Healthcare NHS Trust in the United Kingdom.