FDA approves Thoratec's portable VAD (ventricular assist device) driver:
This article was originally published in Clinica
The US FDA has approved Thoratec's PMA supplement application for its TLC-II portable ventricular assist device (VAD) driver. Weighing just 20lbs (9.1kgs), the device is the only one of its kind that can provide left, right or biventricular support to patients awaiting heart transplantation or recovering from open-heart surgery, says its Pleasanton, California manufacturer. Under the new approval, the VAD driver can be used to allow certain patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver. Thoratec is also evaluating the device for use in patients discharged from hospital to their homes (see Clinica No 934, p 17).