The data showed TAVI to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR. TCT: Large Study Demonstrates Exceptional Safety and High Procedural Success With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS), ACC, CRF Announce Martin B. Leon Center for Cardiovascular Transformation, Medtronic Launches Head-to-Head TAVR Study Comparing the Evolut TAVR Platform Against the Edwards Sapien Valve in Small Annulus Patients, Micro Medical Solutions Announces CE Mark Approval of 2.5mm MicroStent and MicroBalloon XL, TCT: NuVera Medical Announces Positive Results From First-in-human Feasibility Study, Constrictive Pericardial Hemodynamics Made Easy: Clinical Editor's Corner Live Discussion, International Symposium on Endovascular Therapy, Symposium on Clinical Interventional Oncology. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), … 4544 0 obj
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The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing. The expanded indication approval is based on data from the EVOLUT Low-Risk randomized clinical trial, which evaluated three generations of Medtronic TAVR systems (CoreValve, Evolut R, and Evolut Pro) in more than 1,400 patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If left untreated, symptomatic patients with severe aortic stenosis can die from heart failure in as little as two years. “The low-risk indication marks an important milestone for patients across Europe as TAVI expands into a potentially younger and more active patient population,” said Thomas Modine, M.D., Ph.D, MBA, cardiac surgeon at Hôpital Cardiologique Lille, in Lille, France, and investigator in the Evolut Low Risk Trial. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Further, bicuspid aortic valve stenosis represents almost 40 percent of the intermediate and high risk severe symptomatic aortic stenosis patient population.[ii]. CytoSorbents (NSDQ:CTSO) and Aferetica today announced the European Union approval of Aferetica’s PerLife integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. All Rights Reserved. In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days, the Evolut system demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs (effective orifice area) compared to surgery at one year – factors that may be important for more active patients.
Due to the COVID-19 pandemic the referendum in May 2020 had been postponed. Once loaded with needles and sutures, the device is closed… […], FacebookTwitterLinkedInShare Thermo Fisher Scientific (NYSE:TMO) today announced plans to develop two new sterile filling lines in Singapore to extend capacity to the Asia Pacific region for the development and manufacture of therapies and vaccines. [i] Earlier CoreValve Evolut TAVR trials enrolled patients at an average age of 80 to 83 while the Evolut Low Risk trial enrolled patients at an average age of 74).
If left untreated, symptomatic patients with severe aortic stenosis can die from heart failure in as little as two years. Further, bicuspid aortic valve stenosis represents almost 40 percent of the intermediate and high risk severe symptomatic aortic stenosis patient population. h�bbd``b`k�S�`o�%���@�y)�x � There are two commercially available Medtronic heart valves, the Evolut R, and Evolut PRO valves, that come in different sizes. The implant is currently being observed in a pivotal investigational device exemption study comparing it… […], Proteor USA announced that it has agreed to acquire a significant portion of Freedom Innovations’ lower limb prosthetics portfolio from Otto Bock. This paper discusses the unique design requirements for medical power supplies, and how to select the right medical power supply for your application and product. GE Healthcare launches new computing technology for healthcare providers, Aferetica, CytoSorbents gain EU nod for organ perfusion system, Medtronic CEO Geoff Martha: ‘Time to be bold and add grit’, MDR mutual recognition agreement unresolved after Swiss referendum, Cue Health lands $481M from HHS for COVID-19 test, FDA clears WishBone Medical pediatric external fixation device, FDA clears Origami Surgical suture-delivery device, Medtronic launches head-to-head TAVR study against Edwards, Report: Eli Lilly halts COVID-19 treatment trial, Diversity in medtech: Just 20% of executive roles held by women, CartiHeal wins FDA breakthrough designation for Agili-C implant, U.S. Supreme Court to hear Arthrex challenge to constitutionality of patent judges, FDA clears GE Healthcare AI-powered cardiovascular ultrasound system, Vaccine trial pause sees Johnson & Johnson dip despite strong Q3, Thermo Fisher to add $130M factory in Singapore, Orchid appoints ConMed, Zimmer veteran as CEO. Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.”. The valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), … $�/R�$�J101 h�b```��lu ��ea�h(x��� B Jurkiewicz will consider supporting the company through a transition period. “While surgical valve replacement will still be an option for many patients, we anticipate TAVI to be accepted as an important valve replacement therapy in patients for whom it is an appropriate treatment option. The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) against SAVR in more than 1,400 patients. Italian startup Aferetica designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure… […], Spartech announced today that John Inks has been promoted to CEO. CoreValve, Evolut R, and Evolut PRO were approved for use in patients at intermediate risk for surgery in July 2017. “The low-risk indication marks an important milestone for patients across Europe as TAVI expands into a potentially younger and more active patient population,” said Thomas Modine, M.D., Ph.D, MBA, cardiac surgeon at Hôpital Cardiologique Lille, in Lille, France, and investigator in the Evolut Low Risk Trial.
Earlier CoreValve Evolut TAVR trials enrolled patients at an average age of 80 to 83 while the Evolut Low Risk trial enrolled patients at an average age of 74). The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement (SAVR) and includes patients who may be younger[i] and more active than higher-risk patients.
The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) against SAVR in more than 1,400 patients. FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery. “Based on excellent data from the STS/ACC TVT Registry, bicuspid patients (excluding low risk), will for the first time, be indicated for TAVI, which is another big win for patients and the future of the therapy.”, Bicuspid aortic valves are a congenital heart defect affecting 1-2 percent of the general population and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid). �c�y[��������7�J���u)z��|~{���B�3Ւ%
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All rights reserved. The CoreValve device leads the industry in longer-term clinical data, reporting durability data out to 8 years with the Italian Registry on the original CoreValve TAVI. The Evolut TAVR platform is indicated in the U.S. for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low). Bicuspid aortic valves are a congenital heart defect affecting 1-2 percent of the general population and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid). Severe aortic stenosis, which occurs when the aortic valve becomes diseased (stenotic), affects approximately more than 500,000 patients in western Europe per year. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVI group. The Evolut TAVI Platform Receives New Indication for Patients with Bicuspid Aortic Valves at Extreme, High or Intermediate Risk of Surgical Mortality.
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