Of the 186 accredited practitioners, 16 had not performed any LVAs
in the specified time period.
The company reports the Diabetes and Heart Center in Bad Oeynhausen, Germany, has now implanted four CorAide LVAS
In addition to the increased reimbursement for DT, CMS is now also reimbursing the use of the HeartMate LVAS
and the Thoratec LVAD when used as a bridge to heart transplantation under DRG 103, section 376.
World Heart also announced it has had discussions with officials of the Centers for Medicare and Medicaid (CMS) and says it is confident that with a trial design satisfactory to CMS, reimbursement coverage will be extended to both Novacor LVAS
and HeartMate used in the trial, on the same basis as is available for use of LVADs as destination therapy.
The Novacor LVAS
is commercially approved as a bridge to transplantation in the US and Canada.
On November 6, the Food and Drug Administration gave Thoratec the go-ahead to market its LVAS
as permanent support for end-stage heart failure patients who are not eligible for transplantation.
World Heart Corporation, Ottawa, Ontario, Canada, announced it has received CE Mark approval to introduce an enhanced version of its ePTFE conduit for use with its Novacor left ventricular assist system (LVAS
The FDA's Circulatory System Advisory Panel has recommended that the agency approve, with conditions, Thoratec, Inc's., Pleasanton, CA, request for a Premarket Approval supplement (PMAs) for use of HeartMate, the company's left ventricular assist device (LVAS
World Heart Corporation, Ottawa, Ontario, announced that Health Canada has given approval to begin a study designed to test the long-term support abilities of the Novacor LVAS
(left ventricular heart system) in end-stage heart failure patients who are eligible for a transplant.
Robert (Pete) Kenyon, who had been kept alive by a Novacor LVAS
(left ventricular assist system) for nearly 3 1/2 years, received a new heart on January 2nd, 2002 at Yale-New Haven Hospital in Connecticut.
Thoratec Corporation, Pleasanton, CA announced the FDA has agreed to provide an expedited Premarket Approval (PMA) supplement seeking expanded approval for its HeartMate left ventricle assist system (LVAS