VCR ventracor limited

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  1. 4,770 Posts.
    wrong article ning nong! Sorry here's the article re the bi-ventricular product approved last week from Thoratec:

    Thoratec Receives U.S. Approval for Thoratec IVAD(TM)
    Thursday August 5, 4:05 pm ET


    PLEASANTON, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR - News), a world leader in products to treat cardiovascular disease, said today that it has received FDA approval of its PMA (PreMarket Approval) Supplement to market the Thoratec IVAD (Implantable Ventricular Assist Device) in the U.S.
    The IVAD is an implantable version of the successful Thoratec® VAD System. More than 2,700 Thoratec VAD pumps have been implanted worldwide. It is the only currently approved implantable cardiac assist device that can provide left, right or biventricular support. Weighing less than a pound, it is the smallest commercially available implantable pulsatile VAD device. The device has been approved for use in Europe for more than a year. Under the terms of the FDA approval, Thoratec will compile a registry detailing the experiences of the first 50 patients implanted with the IVAD post-approval.

    "This approval furthers our industry-leading line of cardiac assist devices and we believe provides a wider range of treatment options for clinicians. Because of its size, the IVAD allows for implantation in patients who due to their small body size could not previously be treated with an implantable, pulsatile VAD. In addition, the IVAD is driven by the FDA approved Thoratec TLC-II(TM) enabling patients to be discharged to their homes," said D. Keith Grossman, president and chief executive officer of Thoratec.

    "The clinical experience with the IVAD has been a positive one, with no serious device malfunctions or unanticipated adverse events, and patients have been pleased with how comfortable and quiet the device is," he added.

    The approval was based on data from both U.S. and European clinical trials that involved 30 patients and cumulative support of more than 2,400 patient days with no device failures. One patient was supported for nearly ten months and patients enrolled in the trial ranged in age from 16 to 71 years old.

    Whereas the Thoratec VAD rests outside the patient's chest area, the IVAD's smaller size, design and construction enable internal placement resulting in greater comfort, mobility and patient satisfaction. Both devices support heart function and blood flow in late-stage heart failure patients who are most frequently awaiting heart transplantation or recovering from open heart surgery. The IVAD uses the same internal working components of the proven Thoratec VAD System blood pump with a casing comprised of a titanium alloy.

    Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec VAD and HeartMate® LVAS (left ventricular assist system) with more than 8,500 devices implanted in patients suffering from heart failure. Thoratec's product line also includes the Vectra® vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com or http://www.itcmed.com .

 
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