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June 19, 2014
08:09 EDTMDTMedtronic announces preliminary outcomes for Micra TPS
Medtronic announced preliminary results from the first human implants of the world's smallest pacemaker, the Micra Transcatheter Pacing System, or TPS. Results from the first four patients to receive the Micra TPS were reported at CARDIOSTIM / EHRA EUROPACE 2014, World Congress in Electrophysiology and Cardiac Techniques, in Nice, France. At 1 month and 3 months, results showed the Micra TPS was successfully implanted in all patients, whose ages ranged from 74 to 83 years, and there were no major complications post-implant. The device performed as expected, and electrical values were within normal ranges. The Micra TPS is an investigational device worldwide and not approved in the U.S., and its safety and efficacy is currently being evaluated in the Medtronic Micra Transcatheter Pacing System Global Clinical Trial. The Trial is a single-arm, multi-center study that will enroll up to 780 patients at approximately 50 centers.
News For MDT From The Last 14 Days
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July 2, 2015
12:05 EDTMDTMedtronic reports 12-month results of VeClose pivotal study
Medtronic announced the twelve- month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal closure system for the treatment of incompetent greater saphenous veins with a 96.8% closure rate. The results were presented by National Principal Investigator, Nick Morrison, M.D., Morrison Vein Institute, Scottsdale, Ariz., at the European Venous Forum 2015 in St. Petersburg, Russia. 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 ClosureFast catheter and demonstrated non-inferiority of the VenaSeal closure system: At three months, the complete closure of the great saphenous veins achieved in more than 98.9% of patients treated with the VenaSeal closure system compared to 95.4% of patients treated with the ClosureFast catheter, showing non-inferiority of VenaSeal (p<.0001). The closure rate at six months was 98.9% and 94.3% for the VenaSeal closure system and the ClosureFast catheter, respectively. At 12 months, closure rates were identical between the two treatment groups at 96.8%. Additionally, no serious adverse events were reported.
June 29, 2015
18:13 EDTMDTMedtronic says AHA/ASA recommends stent retriever technology
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June 25, 2015
11:03 EDTMDTMedtronic announces U.S. launch of Advisa SR MRI SureScan pacing system
Medtronic announced the U.S. FDA approval and commercial launch of the Advisa SR MRI SureScan single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging 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.
09:23 EDTMDTMedtronic announces resignation of Christopher O'Connell
Medtronic (MDT) announced in a regulatory filing that Christopher J. O’Connell is resigning as the company’s EVP and President, Restorative Therapies Group. The company also announced the appointment of Geoff Martha as the company’s EVP and President, Restorative Therapies Group, effective immediately. The Fly notes that Waters (WAT) this morning named O'Connell as its new president, CEO and member of its Board of Directors, effective in September.
09:15 EDTMDTWaters names Christopher O'Connell as CEO, effective in September
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June 23, 2015
17:03 EDTMDTMedtronic implements voluntary recall for certain lots of Covidien Shiley tubes
Medtronic announced that on May 8, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to November 29, 2012 addressed the patient breathing difficulty or discomfort. The notification requested all customers and distributors to quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit. Medtronic also took the necessary steps to prevent future shipments of the recalled products. The company also notified regulatory agencies around the world, as appropriate. Since November 29, 2012, Shiley tracheostomy tubes were shipped into Australia, Belgium, Canada, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, Uruguay and the United States of America.
11:20 EDTMDTMedtronic competitive with Edwards after approval, says Wells Fargo
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09:22 EDTMDTMedtronic announces FDA approval for new TAVR system
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07:25 EDTMDTPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 21, 2015
12:42 EDTMDTMedtronic reports five-year follow-up results for Endurant AAA stent graft
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