Medtronic, Inc. has announced the CE Mark and international launch of its 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.
Background
Medtronic claims it is “optimizing the treatment of coronary artery disease with a new foundation for future stent innovations” with the introduction of so-called CoreWire Technology. This design innovation means the stent is able to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity and thinner struts to help improve deliverability without compromising radial and longitudinal strength. The Resolute Onyx DES is the first to feature CoreWire Technology.
Resolute Onyx DES also features a new delivery system with PowerTrac™ technology that was introduced earlier this year with the NC Euphora(TM) Noncompliant Balloon Dilatation Catheter. The advanced delivery system provides superior and enhanced deliverability through challenging lesions.
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) which hints at the prospect of reduced duration. In clever use of language the IFU states that “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.”
…..and…
“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.”
Physician comments
“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.
Company comments
“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.”
Source: Medtronic, Inc.
published: November 3, 2014 in: Approval/Clearance, Cardio, Medtronic