2 million reflects completion of enrollment in destination therapy
clinical trial and international currency weakness
In December 2014, SynCardia's investigational device exemption application to conduct a study of the effectiveness of the SynCardia Total Artificial Heart for destination therapy
was approved by the FDA.
Tucson, AZ, announced the US Food and Drug Administration (FDA) has approved two Humanitarian Use Device (HUD) designations for its new 50cc Total Artificial Heart to be used for destination therapy
and pediatric bridge to transplant.
Certification for Loma Linda University Medical Center " paves the way for payment by Medicare for patients receiving the HeartMate II for destination therapy
," Atienza concuded.
The approval of the HeartMate II, the continuous-flow left ventricular assist device, has been expanded to include its use as destination therapy
for people with severe heart failure who are not acceptable candidates for heart transplantation.
Originally used only as "bridge" to support hospital-bound patients for whom a heart transplant was both urgent and imminent, LVADs are now also used as destination therapy
for patients who are ineligible for a transplant.
FDA grants conditional approval for Destination Therapy
(DT) Clinical Trial protocol - December 2006
Ventracor has announced the United States Food & Drug Administration (FDA) has granted conditional approval of the protocol for the US Destination Therapy
(DT) trial of the VentrAssist.
Middle Tennessee's only certified Destination Therapy
program offers renewed hope and results for advanced heart failure patients--
Investigators Report Data from First Cohort in Destination Therapy
at the 35[sup.
Yancy explained that the technologic breakthrough that has finally brought destination therapy
to the fore is the development of small, reliable, totally implantable left ventricular assist devices (LVADs) featuring continuous-flow rotary pumps.
The LVADs are used in the Bridge-to-Transplantation (BTT), destination therapy
and bridge to recovery.