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.
Most of the second and third generation stents currently in use have much thinner struts than the first generation devices and, as a result, have shown better outcomes in terms of healing, with low (or no) incidents of late stent thrombosis. The Onyx furthers this trend with even thinner struts. This new stent is also available in a new 2.0mm diameter for narrow arteries.
Of note is the CE Mark labeling which references the safety outcomes from the Global RESOLUTE Program, previously reported on Angioplasty.Org: namely that "while physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis."
This morning's press release from Medtronic, Inc. follows:
Medtronic Launches Resolute Onyx™ Drug-Eluting Stent Following CE Mark
First and Only DES with Novel CoreWire Technology Allows for Thinner, Stronger Struts, Enhanced Deliverability and Radiopacity without Compromising Structural Strength
November 3, 2014 -- Minneapolis -- Optimizing the treatment of coronary artery disease with a new foundation for future stent innovations, Medtronic, Inc. (NYSE: MDT) today announced CE (Conformité Européene) mark and international launch of the Resolute Onyx™ Drug-Eluting Stent (DES). The first live patient implant of the Resolute Onyx DES occurred recently during the XII International Course of Endovascular and Myocardial Therapy in Madrid, Spain. The Resolute Onyx Drug-Eluting Stent is not approved in the United States.
Dr. Eulogio Garcia |
"Following my experience with the Resolute Onyx DES, I've been able to see first-hand how the CoreWire Technology offers improved deliverability in complex lesions, enhanced conformability to the vessel wall and greater radiopacity for more accurate stent placement," said Eulogio Garcia, M.D., an interventional cardiologist at the Hospital Universitario Clínico San Carlos, Madrid, Spain, who performed the first implant of the device.
Built on the proven clinical performance and superior deliverability of the Resolute Integrity DES, the Resolute Onyx DES is the first stent to feature a new advancement called CoreWire Technology that allows it to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity (i.e., visibility during the procedure) and the Resolute Onyx DES has thinner struts to help improve deliverability without compromising radial and longitudinal strength.
Resolute Onyx DES features a new delivery system with PowerTrac™ technology that was introduced earlier this year with the NC Euphora™ Noncompliant Balloon Dilatation Catheter. The advanced delivery system provides superior and enhanced deliverability through challenging lesions.
CoreWire Technology is the next new DES advancement after Continuous Sinusoid Technology (CST), which was previously introduced with the Resolute Integrity DES and the Integrity bare-metal stent. CST is a method of stent manufacturing that molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion.
"CoreWire Technology is an exciting innovation that will have measurable impact on clinical practice today and tomorrow," said Jason Weidman, vice president and general manager of the coronary and renal denervation business unit at Medtronic. "The advancements of the Resolute Onyx DES specifically address the need for continued procedural efficiency and ease-of-use. Importantly, and in contrast to some current DES technologies, it achieves meaningful deliverability enhancement with no compromise to stent strength."
Available in a broad size matrix (including a new 2.0 mm diameter), the CE mark labeling for Resolute Onyx DES includes information on one month of dual antiplatelet therapy (DAPT). The labeling states: "One year data from the Global RESOLUTE Program indicates low stent thrombosis rates for those who interrupted or discontinued DAPT any time after one month. While physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis."
Resolute Onyx expands Medtronic's interventional cardiology 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 two years.
The Resolute Onyx DES is now available in select countries that recognize the CE mark.
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.
About Medtronic
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.
