Monday, January 20, 2020
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    Medtronic Reports: InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads Receives CE Mark

    The availability of the new technologies on January 15 will expand access to sacral neuromodulation (SNM) therapy for thousands of potential European patients by offering full-body MRI scan eligible, lifestyle-friendly choices with either the InterStim Micro or InterStim II neurostimulators.

    New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker

    The results from the MARVEL 2 study will be presented Nov. 16 during a Featured Science session at American Heart Association 2019, the AHA Scientific Sessions and were published today in JACC: Clinical Electrophysiology.

    Medtronic Files Suit Against Axonics for IP Infringement

    The suit was filed in the United States District Court for the Central District of California, seeking injunctive relief and damages for infringement.

    Medtronic Receives FDA “Breakthrough Device Designation” for Developing Fully Implantable Heart Pump

    The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

    Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm

    The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

    Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

    The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalizing the connections between the brain, bladder and bowel. It is 80% smaller than the current recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years. Additionally, the SureScan full-body conditional MRI leads will enable patients to undergo imaging procedures that were not previously indicated under the current FDA approval for the InterStim II system.

    New Clinical Trial to Study Infuse Bone Graft in TLIF Spine Procedures

    A TLIF is a type of surgery that fuses - or joins - bones of the spine through a posterior approach. It is used to treat certain painful conditions of the lumbar - or low back - region of the spine.

    Medtronic Reports FDA Approval and U.S. Launch of Next-Generation EvolutTM PRO+ TAVR System

    The Evolut PRO+ TAVR System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market. 

    Medtronic Introduces EnvisionTM Pro Continuous Glucose Monitoring in Europe

    This new technology will empower healthcare professionals and their patients with either type 1 and type 2 diabetes to see accurate glucose levels and trends over time to develop more optimal diabetes therapy plans.

    Reimbursement in Germany for MiniMedTM 670G Insulin Pump System for Individuals with Type 1 Diabetes Announced

    has secured reimbursement for the MiniMedTM 670G insulin pump system with the German Federal Association of the Statutory Health Insurances.

    Commencement of Pivotal Trial to Evaluate New Extended Wear Infusion Set

    The goal of the study will be to collect clinical data to support the use of the extended wear infusion set for up to seven days - more than twice the length of time that any infusion set can currently be used.

    Acquisition of Titan Spine Completed

    A definitive acquisition agreement between the two companies was previously announced on May 9, 2019. The acquisition of Titan Spine strengthens Medtronic’s position as a leading innovator in procedural solutions for spine surgery.

    Statement from Medtronic Regarding FDA Circulatory System Devices Panel

    The panel presentations and deliberations addressed a wide range of considerations related to paclitaxel drug-coated balloons (DCB) and drug-eluting stents (DES). Laura Mauri, M.D., vice president, Global Clinical Research & Analytics, Medtronic also presented alongside Dan Clair, M.D., chair of the Department of Surgery for the University of South Carolina (USC) and the Palmetto Health-USC Medical Group and Eric A. Secemsky, M.D., MSc, RPVI, FACC, FVSM, Beth Israel Deaconess Medical Center, Harvard Medical as part of an unprecedented pan-industry presentation.

    Forthcoming Robotic Assisted Surgical Platform to Feature Three-Dimensional Vision System from KARL STORZ

    To enable upcoming regulatory filings, Medtronic plc (NYSE:MDT) today made public its partnership with KARL STORZ SE & Co. KG (Tuttlingen, Germany), a pioneer...

    Medtronic Gains U.S. FDA Clearance for SelectSite C304-HIS Deflectable Catheter System

    The SelectSite C304-HIS deflectable catheter system features a deflectable, out-of-plane curve to reach the bundle of His and is designed to enable enhanced range maneuverability, fixation and implant success for a wider range of patient anatomies.

    Medtronic Launches Telescope Guide Extension Catheter to Support Complex Coronary Cases

    Medtronic plc (today announced its entrance into the guide extension catheter market with the global launch of the Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide additional backup support and access to distal lesions. Guide extension catheters help deliver coronary stents, balloons and other interventional devices during angioplasty procedures that help to restore blood flow through the coronary and peripheral arteries.

    Underuse of Implantable Cardiac Devices

    Three new studies show that patients who are medically indicated for implantable heart devices, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy often do not receive needed therapy.

    Smile Study Data Demonstrates Safety & Effectiveness of the MiniMed 640G System

    Medtronic plc announced the publication of the SMILE study in The Lancet Diabetes & Endocrinology.

    5/2/19: FDA Approval for CareLink SmartSync Device Manager Reported by Medtronic

    Medtronic plc announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic's BlueSync-enabled implanted cardiac devices.

    4/30/19: Solitaire (TM) X Revascularization Device is Launched by Medtronic in the USA

    Today Medtronic announced the U.S. launch of the Solitaire (TM) X Revascularization Device - and its first use in patients for the treatment of acute ischemic stroke. For ten years, the industry-leading Solitaire(TM) Revascularization Device has enabled physicians in helping patients have a better chance at recovering from stroke.

    New EndoSuture Aneurysm Repair (ESAR) and Valiant Navion(TM) Data Presented at Charing Cross Demonstrate Safety and Efficacy in Patients with Complex Anatomies

    4/17/19: Two-Year Endosuture Aneurysm Repair (ESAR) Data: Medtronic shared preliminary two-year data supporting the safety, durability, and effectiveness of Endurant to treat AAA patients with short aortic necks when used in combination with the Heli-FX(TM) EndoAnchor(TM) system.

    Targeted Drug Delivery is Associated with a Reduction in Health Care Utilization and Cost for Cancer Pain

    4/8/19: The study found significant cost savings to payors, with fewer inpatient visits, shorter inpatient length of stay, and fewer emergency department (ED) visits for the TDD and CMM group.

    Medtronic Statement Regarding IN.PACT Paclitaxel Safety Analysis Correction Letter in The Journal of the American College of Cardiology

    3/1/19: In their previous statement, Medtronic said this programming error impacted the IN.PACT Paclitaxel Safety analysis, which recently presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany and published online in the Journal of the American College of Cardiology (JACC).

    Medtronic Announces FDA Clearance and U.S. Launch of the Accurian Radio Frequency System for Nerve Tissue Ablation

    2/27/19: can perform standard, pulsed, and enhanced procedures using internally-cooled probes to create a comprehensive range of lesion shapes, sizes, and volumes.

    Medtronic Resolute(TM) Drug-Eluting Stent Platform Receives Expanded Indication for Treatment of Chronic Total Occlusion

    2/26/19: CTO is considered more difficult to treat with percutaneous coronary intervention (PCI) due to a greater risk of complications.