Thoratec VAD
This article was originally published in The Gray Sheet
Executive Summary
Ventricular assist device PMA supplement submission to FDA is anticipated by year-end to support a therapeutic recovery indication to reverse late-stage heart failure in certain patients as a viable alternative to transplantation. The device currently is approved for use as a bridge to cardiac transplantation and postcardiotomy recovery of the natural heart. Overall sales of the system increased nearly 40% in the first quarter ended April 1, as the company added ten new treatment centers (five in the U.S. and five internationally) to end the quarter with 140 centers. Corporate sales for the three months increased 41.5% to $7.6 mil., compared to $5.4 mil. in the same period one year ago. Net income of $649,000 compares to a loss of $336,000 in the first quarter of 1999