Biventricular Support Device Shows Promising Results

The device has recently received CE Mark certification, allowing it to be marketed in the European Union.

The approval follows a successful clinical trial involving 17 patients in Europe. A similar trial is still under way in the United States. Combining both trials, 30 patients have been supported by the IVAD for a cumulative support duration of about 2,100 days with no device failures, including one patient supported for about eight months. Patients in the trial ranged in age from 16-71.

The IVAD, in contrast to larger ventricular assist devices that rest outside the patient's chest area, enables internal placement, resulting in greater comfort, mobility, and patient satisfaction, according to Thoratec Corp. (Pleasanton, CA, USA; www.thoratec.com), which developed the device. The IVAD is designed to 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 weighs less than a pound.

"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 CEO of Thoratec.




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