• Filter By:
• Specialty
• Source
• Condition
• Cancer
• Infectious Disease
• Drug
• Training
• Management
• Procedure
• Therapy
• Vaccine
• Nutrition
• Country

FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today. The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots. The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 26, 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. Ortho Kinematics wins Health Canada nod for VMA system Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system. The VMA system from Austin, Texas-based Ortho Kinema...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 5 Source Type: news

HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line. Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombo...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news

HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said. Data from the 465-patient supplemental cohort trial will be used to support pre-market approval for the HeartWare HVAD as a destination therapy system intended for long term use, according to the Framingham, Mass.-based company. The device is currently FDA approved for bridge-to-transplant applications....
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Surgical HeartWare International Inc. Source Type: news