Heart Failure Patient first to have HeartWare’s HVAD Mechanical Circulatory Assist Device Implanted

March 24th, 2006

The first patient, a 48 year old male with heart failure, received an implant of the HeartWare’s HVAD mechanical circulatory assist device on March 22^nd, 2006 at the Vienna General Hospital in Austria.

The surgical team was lead by Dr. Georg Wieselthaler, who is the Clinical Director of Mechanical Circulatory Support with the University of Vienna commented on the progress of the patient, "Our first clinical experience of the HVAD was extremely positive. The procedure was completed quickly and without incident, and our patient's early post-operative recovery has been excellent.  The device's small size and configuration facilitated a relatively fast implant procedure. The surgery took only 85 minutes, significantly less than the time typically required to implant other devices. The patient was moved from the operating theatre into the post operative recovery area, conscious and off ventilation within seven hours. He continues to recover quickly and has met with his family. We are very pleased with these results."

This is a clinical trial that has so far been successful for the HeartWare’s HVAD device.  The trial has the goal for implanting 20 patients with advanced heart failure with the HVAD to complete the study.  The implants will be conducted in various hospitals across Europe.  The HeartWare trial should have the enrollment complete for the 20 patients by the end of 2006.  The study result are hoped to be able to be submitted for approval in the early part of 2007.  HeartWare hopes that the approval for the HVAD will be during the 2^nd half of 2007.

HeartWare’s HVAD is the smallest full output long term circulatory assist device that is currently in development.  HeartWare believes that their HVAD device is the only one of its kind that can be implanted in the area right next to the heart where others implant in the abdomen. 

The HVAD device is hoped to improve the quality of the patient’s health by reducing anticoagulation medication, reduced risk of stroke, and an improved reliability and durability of the device.  The procedure to implant the device will be less traumatic and the patient will recover faster and have fewer post operative complications.

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