|Approval Order Statement |
Approval to expand the indications for use to include transport of patients in fixed wing aircraft and in helicopters. This device, as modified, will be marketed under the trade name thoratec paracorporeal ventricular assist device system and tlc-ii portable vad driver. The pvad is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. When used with the tlc-ii portable pneumatic driver, the pvad is intended for use for transportation of vad patients via ground ambulance, fixed wing aircraft or helicopter. In addition, the tlc-ii portable pneumatic driver can be used to allow suitably-qualified patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver.