MINNEAPOLIS — Continuing its commitment to bringing advanced and clinically relevant interventional technologies to market, Medtronic, Inc. (NYSE: MDT) today announced CE (Conformité Européene) mark and launch of the NC Euphora(TM) Noncompliant Balloon Dilatation Catheter. The NC Euphora Balloon Catheter is now available in Europe and other countries outside of the United States that recognize the CE mark. It is not yet available in the United States.
Following 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. Stent under expansion has been defined as a major risk factor for both restenosis and stent thrombosis adverse events. Post-dilatation with NC balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.
"When using a noncompliant balloon, deliverability and re-cross are important characteristics, especially when faced with challenging coronary anatomy," said Robert Gerber, F.R.C.P., Ph.D., 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."
- PowerTrac(TM) technologyi provides superior deliverability through tight lesions and requires less force to track through tortuous anatomy.
- An optimized tapered tip design and low lesion entry profile that 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.ii
- Strong, durable and flexible LIGHT(TM) (Low Inflation Growth, High Track) balloon material provides high pressure capabilityi, 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.
- Superior growth profile with 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.
- Environmentally friendly packaging and a reduced box size that has a smaller footprint on congested shelves, a broad size range labeled clearly and intuitively, and accompanying educational opportunities.
NC Euphora also expands Medtronic’s interventional portfolio of medical devices across Coronary, Renal Denervation and TAVI, and is the latest in a series of 12 new product introductions planned over the next 2 years.
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology — alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
– end –
Press release via Medtronic.