![]() ![]() The robotic prostatectomy was performed at Duke University Hospital in Durham, N.C. clinical trial for the Hugo robotic-assisted surgery (RAS) system. In December 2022, Medtronic announced the enrolment of the first patient in the Expand URO U.S. ![]() The growing prevalence of various cardiovascular diseases, such as arrhythmia and atrial fibrillation, are driving the market. Per a report by Grand View Research, the global cardiac rhythm management devices market size was $18.1 billion in 2021 and is estimated to expand at a CAGR of 6.5% by 2030. This approval is a noteworthy milestone in achieving the goal of providing a defibrillation solution that treats sudden cardiac arrest while improving the patient experience. Per Medtronic’s management, it is the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature. The growing awareness by patients and physicians about the risks that come with placing leads in the heart or veins is addressed by the Aurora EV-ICD system that offers an extravascular solution and maintains the traditional ICD benefits of pacing and defibrillation therapy. The Aurora EV-ICD system is likely to be commercially available in autumn 2023 in select countries in Europe. Placing the lead outside of the heart and veins is intended to help dodge long-term complications that may be associated with transvenous leads, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections. The Aurora EV-ICD is implanted below the left armpit (in the left mid-axillary region) and the Epsila EV lead is placed under the breastbone (sternum) with a minimally-invasive approach. The system is indicated for patients at risk of life-threatening arrhythmias, who have not had a prior sternotomy and who do not require chronic bradycardia (abnormally slow heartbeat) pacing. The Aurora EV-ICD system offers the life-saving benefits of traditional ICDs while evading certain risks because its lead (thin wire) is placed outside the heart and veins. The recent development is likely to fortify Medtronic’ Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio. The data was presented as late-breaking science at the European Society of Cardiology 2022 and simultaneously published in The New England Journal of Medicine. The Aurora EV-ICD system is investigational in the United States.įor investors’ note, CE Mark approval is backed by the Pivotal Study of Extravascular Implantable Cardioverter Defibrillator (EV ICD), demonstrating its safety and effectiveness endpoints. Medtronic plc ( MDT Quick Quote MDT - Free Report) recently announced the receipt of the CE mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treating abnormal heart rhythms. ![]()
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