This article was originally published in The Gray Sheet
Firm expects FDA to grant PMA supplement approval of the left-ventricular assist device as an alternative to transplant in the near future. "Based on our most recent discussions with the FDA" and upcoming labeling discussions, "we continue to have a great deal of confidence that we are close to receiving approval for destination therapy," President and CEO Keith Grossman reports during an Oct. 23 earnings call. Thoratec also expects a PMA supplement filing for the IVAD implantable ventricular assist device in the first half of 2003...
You may also be interested in...
Jomed's Reitan catheter pump (RCP) is aimed at growing the Swiss firm's U.S. market presence in addition to expanding the leading European stent supplier's cardiovascular product line
Thoratec anticipates Medicare coverage of the HeartMate VE left-ventricular assist device as "destination therapy" in 2003, despite CMS' Oct. 30 announcement that it has referred the procedure to the Medicare Coverage Advisory Committee
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.