DUBLIN, June 05, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES).For HBR patients, whose bleeding risk may be increased by . The Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Resolute Onyx™ system) consists of a balloon-expandable, intracoronary, drug-eluting stent (DES) premounted on a Rapid Exchange (RX) or an Over-the-Wire (OTW) stent delivery system. Resolute Onyx CTO | Medtronic CTO PERFORMANCE BACKED BY EVIDENCE Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Indications, Safety, and Warnings ADVANCED PERFORMANCE Offers exceptional deliverability 1 and enhanced visibility 1 LEARN MORE (opens new window) MORE OPTIONS TO TREAT Wide-encompassing 2.0-5.0 mm size matrix 2,3 Medtronic News Medtronic Resolute Onyx™ Drug Eluting Stent (DES) First to Receive One-Month DAPT Labeling in the U.S. with Expanded Indication for High Bleeding Risk Patients DUBLIN, Oct. 1, 2020 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today The Resolute Onyx DES is the . The Resolute Onyx Stent is used in patients who have a narrowing in their coronary arteries and are at high risk for bleeding due to previous conditions such as advanced age, the need for chronic. The system consists of a catheter . Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Online Media Toolkit for Healthcare Public Relations Professionals Welcome healthcare public relations professionals to the online resource kit for the Medtronic Resolute Onyx™ DES. • Whenusingtwowires,careshouldbe taken when introducing, torquing and entanglement. Following a DAPT interruption at one month on patients with a next generation DES, the Onyx ONE Clear Study by Medtronic (MDT) investigates risk of cardiac death, heart attack and stent thrombosis. Coronary Stents - Resolute Onyx DES | Medtronic Resolute Onyx DES for Coronary Artery Disease Resolute Onyx™ is a drug-eluting stent (DES) that's different by design, which makes it optimized for complex PCI. Per the study results, Resolute Onyx was no way inferior to BioFreedom DCS while meeting its primary composite endpoint of cardiac death, myocardial infarction or stent thrombosis at one-year. MINNEAPOLIS - Nov. 3, 2014 - 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(TM) Drug-Eluting Stent (DES).The first live patient implant of the Resolute Onyx DES occurred recently during the XII International Course . MINNEAPOLIS - Nov. 3, 2014 - 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(TM) Drug-Eluting Stent (DES).The first live patient implant of the Resolute Onyx DES occurred recently during the XII International Course . It's safe and effective in real-world, high bleeding risk patients on 1-month DAPT. The Resolute Onyx coronary stent is FDA-approved for patients undergoing chronic total occlusion (CTO) procedures. Resolute Onyx™ DES is indicated for high bleeding risk (HBR) patients with 1-month DAPT labeling, based on the Onyx ONE Clear Analysis, which studied the most complex HBR patients for greater confidence in short DAPT decisions. A single-wire design with thin, rounded struts for best-in-class The Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system (Resolute Onyx™ system) is a device/drug combination product that consists of the following device components: the Resolute. Resolute Onyx™ DES met the primary endpoint for cardiac death, myocardial infarction, and stent thrombosis, showing non-inferiority vs. BioFreedom™* DCS at 12 months (17.1% vs. 16.9%). Medtronic News Medtronic Resolute Onyx™ Drug Eluting Stent (DES) First to Receive One-Month DAPT Labeling in the U.S. with Expanded Indication for High Bleeding Risk Patients DUBLIN, Oct. 1, 2020 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today 2020. Average age, majority gender, date of publication. Carrev. DUBLIN - February 1, 2016 - Medtronic plc (NYSE: MDT) today announced the recent CE (Conformité Européene) Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES, a next generation drug-eluting stent that is now available in 4.5mm and 5.0mm diameter sizes. 2 Acute Performance First and Only DES with Novel CoreWire Technology Allows for Thinner, Stronger Struts, Enhanced Deliverability and Radiopacity without Compromising Structural Strength. Box of 01 $999.00 The index procedure was prompted by unstable angina. Mercy is the only hospital in the area to use the new drug-eluting stent for patients with coronary artery disease. It's safe and effective in real-world, high bleeding risk patients on 1-month DAPT. Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic device used in the patient cohort may have caused or contributed to the deaths was provided. Resolute Onyx™ Zotarolimus-eluting Coronary Stent System Indications The Resolute Onyx™ Zotarolimus-eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of The Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Resolute Onyx™ system) is a device/drug combination product comprised of the following device components: • A Resolute Onyx™ Coronary Stent and delivery system. November 02, 2014. Medtronic Launches Resolute Onyx (TM) Drug-Eluting Stent Following CE Mark. The Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Resolute Onyx™ system) consists of a balloon-expandable, intracoronary, drug-eluting stent (DES) premounted on a Rapid Exchange (RX) or an Over-the-Wire (OTW) stent delivery system. The Resolute Onyx DES platform is designed to address the most challenging cases, supporting your increasingly complex practice. The Resolute Onyx Zotarolimus-Eluting Coronary Stent System is intended to treat a narrowed blood vessel (coronary artery) caused by coronary artery disease. Unique sizes4.50 and 5.00 mm sizes are not available in OTW. Resolute Onyx™ is a drug-eluting stent (DES) that's different by design, which makes it optimized for complex PCI. 034. Resolute Onyx DES is well suited to treat large coronary vessels including the left main coronary artery with its optimal sizes and conformability in bifurcation lesions due to Continuous Sinusoid Technology. A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent 1.2 Objective The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus- Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent. INDICATIONS. The Resolute Onyx™ stent is manufactured from a composite material of cobalt alloy and No reflow post stent placement most likely related to debris shift. During the index procedure, the patient had one resolute onyx drug-eluting stent implanted in the rca graft. Download Infographic (opens new window) Indications, Safety, and Warnings Onyx ONE Month DAPT Program Onyx ONE Global Trial Onyx ONE Clear Study October 1, 2020 -- Dublin -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ DES. Medtronic's Resolute Onyx Drug-Eluting Stent October 1, 2020 -- Dublin -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR . The Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Indications. 1016/j. "The RESOLUTE ONYX 2.0 mm Clinical Study builds on the positive body of evidence supporting the clinical performance of the Resolute Onyx stent," said Jason Weidman, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. the resolute onyx™ zotarolimus-eluting coronary stent system is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 … Complex Patients1 74 years average age Nearly 50% with ACS 39% with diabetes 1 Download Brochure (opens new window) 2. stent (Medtronic Integrity Coronary Stent) in combination with a stainless steel alloy stent (Boston Scientific Liberté® Coronary Stent) do not suggest an increased risk of in vivo corrosion. 12. The Resolute Onyx™ stent is manufactured from a composite material of cobalt alloy and 2.00 to 5.00 mm sizes with greater expansion capabilities to treat more patients. Resolute Onyx DES is well suited to treat large coronary vessels including the left main coronary artery with its optimal sizes and conformability in bifurcation lesions due to Continuous Sinusoid Technology. Learn more about the indications for use. The Resolute Onyx DES is the first-and-only DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT - the combination of aspirin and an anti-clotting medication - following a percutaneous coronary intervention (PCI) in patients at high bleeding risk. The Resolute Onyx™ stent is manufactured from a composite material of cobalt alloy and DUBLIN - February 1, 2016 - Medtronic plc (NYSE: MDT) today announced the recent CE (Conformité Européene) Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES, a next generation drug-eluting stent that is now available in 4.5mm and 5.0mm diameter sizes. The delivery system is available in a rapid exchange (RX) and an over-the-wire (OTW) configuration. Org/10. Your browser does not support the video tag. The Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system (Resolute Onyx™ system) consists of a balloon-expandable, intracoronary, drug-eluting stent (DES) premounted on a rapid exchange (RX) or an over-the-wire (OTW) stent delivery system. > Press Releases - Medtronic < /a > the index procedure was prompted by unstable angina careshouldbe taken when,... Patients with coronary artery disease with a new a myocardial infarction in the rca and... 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