This new stent builds on the success of the Resolute Integrity, utilizing Medtronic's unique continuous sinusoid technology to fashion the entire stent from a single strand of wire: a structural design which enhances flexibility without compromising strength.
What makes the Onyx different is that the wire itself consists of a dense inner core, wrapped in a cobalt alloy outer layer. Dubbed CoreWire Technology, this enhancement makes the stent more radiopaque (easier to see under fluoroscopy), and stronger, even though the struts are thinner.
The first phase of this trial will be studying one of the most challenging clinical scenarios: blockages in arteries that measure as small as 2.0mm. Normally drug-eluting stents are not used in arteries this narrow because of the increased incidence of stent thrombosis and restenosis. But the Onyx has thinner struts than the first and second generation DES devices and has shown positive outcomes in these narrow vessels.
Dr. Roxana Mehran of Mount Sinai in New York and principal investigator for this study called blockages in these small diameter arteries "one of the biggest challenges we face as interventional cardiologists...a common condition seen frequently in patients with diabetes."
Medtronic Initiates Pivotal Studies of Resolute Onyx™ Drug-Eluting Stent in United States
Next-Generation Device with CoreWire Technology to be Studied in Wide Spectrum of Patients, Including the Smallest Coronary Arteries
March 12, 2015 -- Dublin -- Medtronic plc (NYSE: MDT) today announced the start of its Resolute Onyx™ Clinical Program in the United States, which will evaluate the Resolute Onyx™ drug-eluting stent (DES) in patients who have coronary artery disease. Included in the first phase of the study are patients with small vessels that would require a 2.0 mm stent, which until now, often were untreatable with a DES. Core sizes of the stent will be studied separately.
Dr. Roxana Mehran |
"One of the biggest challenges we face as interventional cardiologists is treating small, diseased coronary arteries - a common condition seen frequently in patients with diabetes," said Roxana Mehran, M.D., cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City, and principal investigator for the study. "The trial initiation of the Resolute Onyx DES with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions."
CoreWire Technology: dense inner core, wrapped in cobalt alloy outer layer; entire stent is molded from a single strand of wire |
Built on the proven clinical performance and superior deliverability of the Resolute Integrity DES, the Resolute Onyx DES features CoreWire Technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer. The new technology not only enables the stent to have better radiopacity (visibility) during the procedure, but with thinner struts, the stent is designed to help improve deliverability without compromising radial and longitudinal strength, all of which help improve the efficiency of procedures.
CoreWire Technology builds on Continuous Sinusoid Technology (CST), a method of stent manufacturing first introduced with the Resolute Integrity DES, which molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion.
"CoreWire Technology represents a new foundation for drug-eluting stent innovation that optimizes the treatment of coronary artery disease," said Jason Weidman, vice president and general manager of the coronary business at Medtronic. "With approval to begin studying this device in the United States, we hope to demonstrate how this technological advancement enables the Resolute Onyx DES to become a workhorse device for U.S. physicians that can increase procedural efficiency and enhance deliverability in a broad range of vessel sizes.
Resolute Onyx DES also features a new delivery system with PowerTrac™ technology that was introduced last year with the NC Euphora™ Noncompliant Balloon Dilatation Catheter.
The Resolute Onyx DES received CE (Conformité Européene) mark in November 2014 and is available for use in countries that recognize the CE Mark. The Resolute Onyx DES is not available for use in the United States outside of this clinical program.
In collaboration with leading clinicians, researchers and scientists worldwide, 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 around the world.
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Medtronic plc (www.medtronic.com), headquartered in Dublin, 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.
