March 22, 2017: Medtronic Inc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.
The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.
The Evolut PRO Clinical Study (N=60) met its primary endpoint at 30 days with high rates of survival (98.3 percent) and low rates of disabling stroke (1.7 percent). The Evolut PRO valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm2) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of study subjects (72.4 percent) experienced no/trace PVL and no incidents of severe PVL were observed at 30 days. Additionally, improving on the already low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries, the rate of new pacemaker implantation was 10 percent.
The 23 mm, 26 mm and 29 mm sizes of the Evolut PRO System are available for use in the United States. It is not available for use in countries outside of the United States.
February 17, 2017: Medtronic announced Japan regulatory approval for the world’s smallest pacemaker, the Micra(TM) Transcatheter Pacing System (TPS). Japan’s Pharmaceuticals and Medical Device Agency (PMDA) granted approval for Micra based on positive data from the Medtronic Micra TPS Global Clinical Trial, which enrolled 744 patients and evaluated the safety and efficacy of the device through a single-arm, multi-center study at 56 centers in 19 countries, including Japan.
Approved by the U.S. Food and Drug Administration (FDA) in April 2016 for patients who need a single-chamber pacemaker, the Micra TPS is the first and only leadless pacemaker approved for use in the United States. Micra was recently named at the top of US News & World Report’s list of “2016’s Biggest Achievements in Medicine.” It is approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans.
Comparable in size to a large vitamin, the Micra TPS is less than one-tenth the size of traditional pacemakers, yet delivers the most advanced pacing technology to patients via a minimally-invasive approach. During the implant procedure, it is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical “pocket” under the skin, so potential sources of complications related to such leads and pocket are eliminated – as are any visible signs of the device.
The Micra design incorporates a retrieval feature which can be enabled when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS can be permanently turned off, allowing it to remain in the body so a new device can be implanted without risk of electrical interaction.
Preliminary results from the Medtronic Micra TPS Global Clinical Trial, published in theNew England Journal of Medicine, showed the Micra TPS was successfully implanted in 99.2 percent of patients and that the system met its safety and effectiveness endpoints with wide margins. In August 2016, new long-term data presented in a late-breaking clinical trial at the European Society of Cardiology congress continued to reinforce these results, demonstrating consistent and sustained outcomes from early performance through 12-month follow-up.
In collaboration with leading clinicians, researchers and scientists worldwide, 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 of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
February 15, 2017: Medtronic announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for the OsteoCool RF Ablation System. Originally cleared for use in the spine, the FDA now allows the marketing of the OsteoCool System for palliative treatment of metastases in all bony anatomy – such as ribs, sacrum, extremities, and hip – in patients who have failed or are not candidates for standard therapy. The system uses targeted radiofrequency energy to ablate malignant metastatic bone tumors.
Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system.
The OsteoCool system is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities – providing for procedural flexibility and predictable, customized treatment. The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure.
The device also has a CE mark for the ablation of benign bone tumors such as osteoid osteoma and palliative treatment of metastatic malignant lesions involving bone, including the vertebral body. This indication is not available in the United States.
February 6, 2017: Medtronic was awarded a national contract from the U.S. Department of Veterans Affairs (VA) for home Telehealth Technologies. MCMS has supplied the VA with telehealth solutions since 2011, and the new contract enables MCMS to continue supplying the VA with innovative remote patient monitoring technology for one year, followed by four optional one-year periods exercised at the discretion of the VA.
MCMS will provide veterans with a comprehensive suite of technology platforms, multiple connected diagnostic devices, proprietary clinical workflow software, and related telehealth solutions to help clinicians monitor patients with complex conditions, such as heart failure, chronic obstructive pulmonary disease (COPD), diabetes, depression, hypertension, weight loss management, and posttraumatic stress disorder (PTSD). Veterans using MCMS’ services will engage in daily health checks, which not only educate the veteran regarding their condition and self-care but collect symptoms and biometrics through a series of branching logic-based questions. Information received is aggregated and assembled for review online by VA care coordinators, enabling clinicians to monitor a veteran’s condition and consider potential early intervention.
February 1, 2017: Medtronic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CardioInsight(TM) Noninvasive 3D Mapping System. The CardioInsight system is used to map a wide range of irregular heart rhythms in the upper and lower chambers of the heart and provides electroanatomic 3D maps of the heart. The system was first used commercially in the U.S. by Vivek Reddy, M.D., director of cardiac arrhythmia services at the Mount Sinai Hospital and the Mount Sinai Health System, New York.
Cardiac mapping – typically accomplished by inserting a catheter into the heart via an artery or vein – allows physicians to locate the origin of a patient’s irregular heart rhythms (arrhythmias). In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure. Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. Medtronic acquired CardioInsight in 2015, now part of the Medtronic AF Solutions business in the Cardiac Rhythm and Heart Failure division.
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Medtronic is working with new partners, in new ways to improve global healthcare. With the integration of Covidien as our Minimally Invasive Therapies Group, we can address the healthcare needs of more people around the world than ever. Our Executive Committee is responsible for leading a global workforce of more than 85,000 Medtronic employees. To meet the needs of patients and healthcare professionals around the globe, Medtronic operates from more than 260 locations in more than 155 countries. Since our founding in 1949 by Earl Bakken, Medtronic has put people first. We strive to alleviate pain, restore health, and extend life.
As a global organization that works with stakeholders and professionals across the healthcare system, Medtronic is stepping forward to put the full power of our technologies, services, resources — and our people — to work with new partners, in new ways, to usher in a new era in healthcare.
We are working with the global healthcare community to take our technology, services, and insights and fashion them into solutions that either drive operational efficiency within the healthcare system or augment the delivery of care through better patient care management. We are forging new types of relationships with healthcare providers and payers who are committed to building models that improve patient outcomes and reduce costs.