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News Breaks | | | | October 29, 2012 | | 11:51 EDT |  | MDT | Medtronic says Engager European Pivotal Trial showed positive outcomes
Medtronic announced data from the Engager European Pivotal Trial for the investigational Medtronic EngagerTM Transcatheter Aortic Valve Implantation System. The first results from the multi-center trial support the safety and clinical performance of the valve, which uses a transapical delivery approach to treat patients with severe aortic stenosis who were at high or extreme risk for surgical aortic valve replacement. The positive clinical outcomes, presented during a late-breaking trials session at the European Association for Cardio-Thoracic Surgery Annual Meeting, revealed that the Engager system was deployed in the anatomically correct position in all 60 patients. The Engager valve demonstrated strong hemodynamic performance with low transvalvular gradients, and no patients experienced greater than trace paravalvular leak at 30 days as measured by an independent echocardiography core lab, the company said. There were no procedures requiring a second valve, and no occurrences of valve embolization, coronary obstruction or device malposition. The 30-day all-cause mortality rate was 9.9%, the cardiovascular mortality rate was 8.3%, and the incidence of stroke was 1.8%. | |
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News For MDT From The Last 14 Days Check below for free stories on MDT the last two weeks. |
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| May 16, 2013 | | 13:32 EDT |  | MDT | Medtronic volatility flat into Q4 and outlook
 Subscribe for More Information | | | 10:03 EDT |  | MDT | On The Fly: Analyst Downgrade Summary
Subscribe for More Information | | | 06:32 EDT | | MDT | Medtronic downgraded to Neutral from Outperform at Credit Suisse
Subscribe for More Information | | | May 10, 2013 | | 15:49 EDT | | MDT | Medtronic defibrillators demonstrate success of shock avoidance
Subscribe for More Information | | | May 8, 2013 | | 07:38 EDT |  | MDT | BofA/Merrill's medical tech analyst hold an analyst/industry conference call
Subscribe for More Information | | | May 6, 2013 | | 09:19 EDT | | MDT | Medtronic receives FDA approval for newest cardiac devices
Medtronic announced FDA approval and U.S. launch of its newest cardiac devices: the Viva portfolio of cardiac resynchronization therapy with defibrillation, or CRT-D, devices, and the Evera portfolio of implantable cardioverter-defibrillators. | |
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