FDA alerts health care providers to no longer implant heart failure patients with Medtronic s HVAD System
The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.
Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter requesting physicians to stop new implants of the device. This action comes after the company received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was neces
FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease dicardiology.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from dicardiology.com Daily Mail and Mail on Sunday newspapers.
email article
An FDA advisory committee turned thumbs down on Becton Dickinson s Lutonix 014 drug-coated balloon (DCB) for peripheral artery disease (PAD) during a virtual meeting on Wednesday.
Circulatory System Devices Panel members voted 14-3 (with one abstention) that the benefits of the investigational angioplasty catheter do not outweigh its risks as a treatment for patients with critical limb ischemia (CLI) who have obstructive de novo or non-stented restenotic lesions in below-the-knee (BTK) arteries.
Committee members were largely unconvinced that the Lutonix DCB was supported by adequate efficacy data.
In the pivotal Lutonix BTK IDE trial, the device showed a 10.5% absolute advantage in the primary efficacy endpoint (combined primary patency and limb salvage) at 6 months that was not significant under Bayesian analysis. Such improvement, if any, vanished by 12 months, and the endpoint started to favor the regular percutaneous transluminal angioplasty (PTA) arm by
E-Mail
DALLAS and NEW YORK - February 16, 2021 - The Heart Valve Collaboratory (HVC) announced today that the U.S. Food and Drug Administration (FDA) s Center for Devices and Radiological Health (CDRH) will participate in this collaborative community . A medical collaboratory is a forum in which multidisciplinary private and public sector members work together on medical device challenges to achieve aligned outcomes, solve shared problems, and leverage collective opportunities, in the interest of improving patient care. The FDA s Center for Devices and Radiological Health is committed to fostering innovation while encouraging development of safe and effective technologies for patients, said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA s Center for Devices and Radiological Health. We can continue to protect and promote public health when key stakeholder groups work together. Collaborative communities can contribute to improvements in are