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Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy. “With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints in t...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for December 6, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. MedyMatch looks to future of stroke detection with AI platform launch Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain blee...
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 16, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. St. Jude Medical’s HeartMate 3 implantable pump beats HeartMate II in pivotal trial The next-generation HeartMate 3 implantable pump St. Jude Medical acquired when it paid $3 billion for Thoratec last year proved superior to ...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news