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Thoratec Corp.

Division of Abbott Laboratories Inc.
www.thoratec.com

Latest From Thoratec Corp.

Abbott Unit Aims To Settle Investor Suit

Thoratec has agreed with plaintiffs to pay $12m to settle a lawsuit alleging the company hid negative information about the company’s heart pump, thus keeping share prices artificially high. A hearing is scheduled on the settlement for next month.

Legal Issues Commercial

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
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Company Information

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