It is important to note that exceeding the backup battery expiration and any associated advisory (or "yellow wrench") alarms do not affect normal HeartMate II LVAS
The company is asking patients who are currently being supported by a HeartMate II LVAS
to contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.
An implantable LVAS
powered by a rotary pumping mechanism, it is significantly smaller than currently approved devices, enabling an easier implantation in a broader population of patients.
Portner came from a registry of patients who received the Novacor LVAS
We know the LVAS
can provide some patients with the opportunity to live long enough to obtain a heart, an opportunity they would not have otherwise," indicates Lawrence R.
The device is restricted for use only by those patients who have been fitted with a Nonpulsatile LVAS
or mechanical heart valve.
A new group of potential patients, allowing elective implantation of the Novacor LVAS
in commercial DT patients needing replacement of a competitor's pump.
The company reports the Diabetes and Heart Center in Bad Oeynhausen, Germany, has now implanted four CorAide LVAS
could continue to be used as a bridge to transplant or as destination therapy, but not as a bridge to eligibility.
In Europe, the Novacor LVAS
has unrestricted approval for use as a bridge to transplantation, an alternative to transplantation and to support patients who may have an ability to recover the use of their natural heart.
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 Corporation, Oakland, CA, announced that, subject to approval of the US Food and Drug Administration (FDA), it intends to conduct a pivotal trial in approximately 30 US centers in which the Novacor LVAS
is compared to HeartMate XVE LVAS
in use as destination therapy for patients suffering from irreversible left ventricular failure who are not transplant candidates.