Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Thoratec Corp.

Division of Abbott Laboratories Inc.
www.thoratec.com

Latest From Thoratec Corp.

ACC 2018 Preview: Zoll's LifeVest, Abbott's HeartMate 3 And Amplatzer, Late-Breaking Trial Devices

New clinical data with the potential to change clinical practice will be presented at the 2018 American College of Cardiology Scientific Session and Expo in Orlando, Fla., Mar. 10-12. Among the planned late-breaking trials and featured research presentations is a study of Zoll's LifeVest wearable external cardioverter-defibrillator following a heart attack; new results from a trial of Abbott's Amplatzer PFO-closure device, and long-term data on Abbott's HeartMate 3 ventricular assist device.

Cardiovascular Cardiology

US FDA Approves Medtronic's HVAD For Destination Therapy

The expanded labeling gives Medtronic's HVAD, acquired when it bought HeartWare last summer, the same indication as Abbott's HeartMate II ventricular assist device.

Approvals Clinical Trials

Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

Quality Control Compliance

HeartMate VAD Controller Recalled After 26 Deaths

Abbott is issuing hardware and software updates in an attempt to resolve an issue in which patients risk injury or death when attempting to switch to a backup controller for HeartMate II left-ventricular assist devices at home.

Cardiology Recalls
See All

Company Information

Advertisement
Advertisement
UsernamePublicRestriction

Register