VCR ventracor limited

vcr retrace, page-13

  1. 2,129 Posts.
    re: + vcr and medicare + stolwyk Hi again Stolwyk,

    Further to your inaccurate comment of.............

    "Thoratek can barely exist now"

    Did you know that Thoratec has total assets of $US471M and that they have a market cap of $US800M?

    Did you also know that Thoratec recently received approval to market their IVAD in Europe? (read press release below)





    Seaking________________correcting





    Latest Addition Makes Four Approved Devices Available in Europe.

    PLEASANTON, Calif., July 28 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today it has received CE Mark certification, providing approval to market the Thoratec IVAD(TM) (Implantable Ventricular Assist Device) in Europe. This makes the IVAD the only currently approved implantable cardiac assist device that can provide left, right or biventricular support.

    The approval follows a successful clinical trial involving 17 patients in Europe. A similar trial is currently underway in the U.S. and the company hopes to file a PMA (PreMarket Approval) Supplement seeking FDA approval later this year.

    Combining both trials, 30 patients have been supported by the IVAD for a cumulative support duration of approximately 2,100 days with no device failures, including one patient who was supported for approximately eight months. Patients enrolled in the trial have ranged in age from 16 to 71 years old.

    The IVAD is an implantable version of the highly successful Thoratec(R) VAD System that has been used in the treatment of more than 2,300 patients worldwide. 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. Weighing less than a pound, it is the smallest commercially available implantable pulsatile VAD device.

    "This approval furthers our industry-leading line of cardiac assist devices. Its size allows for implantation in patients who due to their small body size could not previously be treated with an implantable, pulsatile VAD," said D. Keith Grossman, president and chief executive officer of Thoratec.

    "The clinical experience with the IVAD has been a very positive one, with no meaningful device malfunctions or unanticipated adverse events, and patients are pleased with how comfortable and quiet the device is. In Europe, we now have four approved devices for a variety of different patient populations and the clinical experience with the IVAD has generated a high level of interest among the cardiovascular community in Europe," he added.

    The IVAD uses the same internal working components of the reliable approved Thoratec VAD System blood pump with a casing comprised of a titanium alloy.

    "We were able to achieve European approval relatively quickly because the blood path for the IVAD is designed to be essentially the same as the currently approved paracorporeal VAD System," noted Jeffrey Nelson, president of Thoratec's cardiovascular division. "For this reason, we are hoping for an accelerated approval process in the U.S. as well," he added.

    Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec VAD and HeartMate(R) LVAS (left ventricular assist system) implanted in nearly 5,700 patients suffering from heart failure. In November 2002, the HeartMate was approved by the FDA as the first, and to date, only heart assist device for Destination Therapy, or permanent support, provide a new lifesaving treatment for end-stage heart failure patients ineligible for cardiac transplantation. Thoratec's product line also includes the Vectra(R) vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood coagulation 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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