medtronic plc (MDT) Key Developments
Medtronic plc Announces the Twelve-Month Results of the Veclose Pivotal Study
Jul 2 15
Medtronic plc announced the twelve-month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal(TM) closure system for the treatment of incompetent greater saphenous veins with a 96.8% closure rate. The VenaSeal closure system is a unique, minimally invasive, non-tumescent, non-thermal and non-sclerosant procedure that uses an advanced medical adhesive to close the diseased vein in patients with symptomatic venous reflux disease. Unlike other treatments, the VenaSeal closure system does not require tumescent anesthesia, allowing patients to return to their normal activities following the procedure. The VenaSeal procedure also eliminates the risk of nerve or other heat-related injury associated with thermal-based procedures, and may reduce the need for compression stockings post-procedure. The 12 month results of the VeClose study demonstrated outcomes for the VenaSeal closure system comparable with the closure rates associated with the ClosureFastTM catheter and demonstrated non-inferiority of the VenaSeal closure system.
U.S. Food and Drug Administration Approves Commercial Launch of the Advisa SR MRI(TM) SureScan(R) Single-Chamber Pacemaker with the 5076 MRI Lead
Jun 25 15
Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of the Advisa SR MRI(TM) SureScan(R) single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging (MRI) scans positioned on any region of the body without restrictions. The new system includes the Advisa SR MRI pacemaker and a SureScan lead, which must be used together to be considered MR-conditional. In addition to delivering single chamber pacing with the same SureScan(R) technology used in other Medtronic cardiac devices, the new Advisa SR MRI(TM) pacemaker has improved diagnostic information and storage, and a 35% improvement in battery longevity (when compared to the Adapta(R) single chamber pacing system). The Advisa single chamber pacemaker is the latest addition to a growing number of Medtronic devices that are designed for MRI access including the Advisa DR MRI(R) and Revo MRI(R) dual chamber SureScan pacing systems, the Reveal LINQ(R)Insertable Cardiac Monitoring (ICM) system, SureScan neurostimulation systems and the SynchroMed(R) II programmable drug infusion system which are available worldwide.
Medtronic plc Announces Management Changes
Jun 25 15
Medtronic plc announced that it has named Geoff Martha as Executive Vice President and President, Medtronic Restorative Therapies Group (RTG), effective immediately. Martha will replace Christopher J. O'Connell, who was selected to become Chief Executive Officer of a public company. Martha joined Medtronic in 2011 and currently serves as Sr. Vice President of Corporate Strategy & Business Development, Global Communications and Medtronic Philanthropy. He also serves as the Chief Integration Officer for the Covidien integration. In these roles, he has a broad understanding of Medtronic strategies and operations around the world. Prior to joining Medtronic, Martha served as managing director of Business Development at GE Healthcare, where he was responsible for global business development efforts, including acquisitions, divestitures, joint ventures and equity investments.
U.S. Food and Drug Administration Approves and U.S. Launch of Medtronic plc's CoreValve Evolut R System
Jun 23 15
Medtronic plc announced the U.S. Food and Drug Administration approval and U.S. launch of the new recapturable, self-expanding CoreValve Evolut R System. The first-and-only recapturable and repositionable device available in the U.S., the Evolut R System is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Designed to treat patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body, the CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve System, which has been implanted in more than 75,000 patients in 60 countries. The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo(TM) R Delivery System, which features an InLine(TM) Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch). A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5.0 mm), through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients. Based on the knowledge gained through the extensive experience with the CoreValve System, the Evolut R is optimized to increase conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. An extended sealing skirt on the 26mm and 29mm valve sizes is intended to further promote valve sealing at the annulus. The approval of Evolut R as the first self-expanding, recapturable transcatheter heart valve available in the U.S. follows other significant milestones reached in recent months showcasing the company's leadership in the TAVR market. In March, the CoreValve System was the first TAVR system to be approved in the U.S. for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. Also in March, the highly anticipated two-year data from the High Risk Study of the CoreValve U.S. Pivotal Trial was presented at ACC.15, which showed superior survival benefit at two years for TAVR with the CoreValve System compared to patients who underwent surgical aortic valve replacement (SAVR). The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available for use in the United States. The device is also available in Europe and other countries that recognize the CE (Conformite Europeene) mark.
Medtronic Launches New Gastric Positioning System
Jun 22 15
Medtronic plc has launched new GastriSail gastric positioning system for sleeve gastrectomy procedure. Developed by Medtronic's Minimally Invasive Therapies Group, the GastriSail system combines the benefits of three devices into one, allowing surgeons to consistently size and decompress the stomach pouch and test for leaks without removing and reinserting another device. With fewer device insertions, there is potentially less risk of irritating or injuring the esophagus during the procedure. During a sleeve gastrectomy procedure, surgeons use minimally invasive approaches to remove approximately two-thirds of the stomach to create a small sleeve-shaped pouch. With the new smaller stomach, the patient will feel full faster after eating a small amount of food in a single sitting. The GastriSail system can be used to help guide the surgeon's staple lines to ensure consistent shape of the stomach pouch from procedure to procedure. Once the surgeon positions the GastriSail system in the stomach, the system's unique LED lights illuminate through the stomach tissue allowing the surgeon to see a clear line delineating where the stomach should be dissected, stapled and divided. The company is currently launching the GastriSail system in the US, Europe and the Middle East. The system will be available globally by the end of 2015.