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Medtronic Announces CE Mark and Launch of NC Euphora Coronary Balloon

Tue, 05/20/2014 - 10:26am
Medtronic

Noncompliant Balloon Provides Superior Deliverability and Controlled Growth for Challenging Coronary Angioplasty Procedures

Continuing its commitment to bringing advanced and clinically relevant interventional technologies to market, Medtronic, Inc. has announced CE (Conformité Européene) mark and launch of the NC Euphora 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."

The NC Euphora Balloon Catheter, which will be featured for the first time at the Medtronic booth at the upcoming EuroPCR 2104 congress in Paris, May 20-23, offers clinicians several valuable features, including:

  • PowerTrac technology1 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 stent2
  • Strong, durable and flexible LIGHT (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 expands our interventional portfolio with another clinically-relevant tool that was developed with both interventionalists and cath lab teams' needs in mind," said Jason Weidman, vice president and general manager of Medtronic's coronary business. "With the addition of a premium non-compliant balloon, our interventional customers have a complement to the other innovative Medtronic offerings throughout the entire procedure for their most difficult and challenging cases."

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.

1 Competitive testing vs. NC Trek and Quantum Apex balloons on file at Medtronic, Inc.
2 Medtronic NC Euphora, NC Trek and Quantum Apex 3.00mm x 20mm balloons tested. Bench test data may not be indicative of clinical performance.

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