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

Doctors Beware: Abbott & #039;s HeartMate 3 Has a Safety Problem
Just when it seemed the HeartMate 3 was gaining momentum, Abbott warned physicians that outflow graft twisting may occur after the left ventricular assist device (LVAD) is implanted. The problem can trigger a persistent low-flow alarm that may signal a potential safety risk to patients, such as blood flow or clotting. The Abbott Park, IL-based company has not recalled any of the devices from patients or hospitals, but there have been 32 reports of outflow graft twisting (an incidence rate of 0.72%), including reports of low blood flow, clotting, and three patient deaths. No devices are being recalled from patients or hosp...
Source: MDDI - May 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Implants Source Type: news

LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or ope...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news