|Medtronic NC Euphora(TM) Coronary Balloon Receives FDA Clearance|
Superior Deliverabilityi and Uncompromising Performance Distinguishes New Angioplasty Balloon
New "Cath Lab Connect" Website Will Provide Catheter Lab Professionals with
MINNEAPOLIS -- Sept. 11, 2014 -- Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora(TM) Noncompliant Balloon Dilatation Catheter. The new device will be featured for the first time in the United States at the Medtronic booth at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Wash., DC from Sept. 13-17.
Following drug-eluting stent implantation to reopen a 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 artery re-narrowing, or restenosis, and the potential formation of blood clots, known as stent thrombosis. Postdilatation with noncompliant balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.
"When developing NC Euphora, insights from the entire cath lab team were gathered and addressed to ensure it meets the current needs of cath lab professionals in device design and performance," said David Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, at the Piedmont Heart Institute in Atlanta, GA. "The advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures."
The NC Euphora Balloon Catheter was designed for uncompromising performance to provide clinicians with several valuable features, including:
"The advanced features of NC Euphora demonstrate that not all balloon catheters are the same," said Chad Dupree, RT(R), cath lab staff member at the Piedmont Heart Institute. "The cath lab team recognizes that balloon catheters are a key component of the procedure, and availability of a device that optimizes stent deployment presents a key opportunity that we have to achieve procedural success."
NC Euphora 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.
"Cath Lab Connect" Website Unveiled
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.
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.
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iCompetitive bench testing vs. NC Trek and Quantum Apex balloons on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance.