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While the HeartMate II LVAS Instructions for Use provides information on monitoring and changing the backup battery before it reaches the 36 month expiration date, Thoratec has recently received reports of patients experiencing advisory alarms for expired System Controller backup batteries.
The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 10,000 devices implanted in patients suffering from heart failure.
Although mortality was high in older patients, the data also showed that a significant number of older patients could survive beyond 1 year on a LVAS.
The wearable LVAS brings us a step closer to the ultimate goal of using mechanical devices as permanent systems or alternatives to heart transplantation.
The Novacor LVAS is now available, within the trial, to DT patients requiring replacement of a failed Thoratec Corporation's HeartMate(R) XVE originally implanted outside of the study.
Arrow discontinued the development, sale and marketing programs of its LionHeart LVAS in April.
We need to plumb the concept of using LVAS for ill patients and then deciding which direction to take the patient.
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.
Like it's Novacor LVAS, the HeartSaverVAD will assume all of the heart's pumping action, while leaving the heart in place.
The company says the conduit carries blood from the natural heart to the Novacor LVAS, which then pumps the blood into the aorta to assist a failing heart.
The presentation was based on a study conducted as part of the REMATCH trial, which compared the experience of patients supported by the HeartMate SNAP-VE LVAS (left ventricular assist system; manufactured by Thoratec Corporation) with those receiving optimal medical management.
The inflow conduit carries blood from the natural heart to the Novacor LVAS.
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