In Brief: St. Jude
This article was originally published in The Gray Sheet
Executive Summary
St. Jude: Begins U.S. marketing of the first three products in its Trilogy line of pacemakers, the DR (dual-chamber, rate-responsive), SR (single-chamber, rate-responsive), and DC (dual-chamber) following FDA approval of PMA supplements for the devices. The DR and DC pacemakers list for approximately $7,000, Pacesetter says, while the SR sells for slightly less. Pacesetter's DR+ and SR+, the "premier" products of the Trilogy line, are in U.S. clinicals under an investigational device exemption received from FDA in December 1994 ("The Gray Sheet" Jan. 2, In Brief)...