AVAILABILITY:

WorldHeart's MiVAD is not currently available for sale or investigational use.

STATUS:

In 2008, WorldHeart and its R&D consortium members for the PediaFlow VAD achieved several development milestones including chronic animal trials with the refined PediaFlow VAD prototype. This has led to a PediaFlow VAD clinical prototype which has been built and is presently being tested. It is anticipated that the design of the Pediaflow clinical prototype will be adapted for MIVAD use.

Overview

Levacor VAD™

MiVAD

Technologies

Minimally Invasive VAD (MIVAD)

WorldHeart's Minimally Invasive VAD (MiVAD) is aimed to provide long-term circulatory support for earlier-stage (Class IIIb) heart failure patients who make up a large number of the 1.2 million Class III patients in the US alone.

Since these patients are less sick than Class IV heart failure patients, they do not need the level of support provided by devices such as the pulsatile Novacor LVAS or the rotary Levacor VAD. Instead, they can be served by a long-term implantable device such as the MiVAD, which is designed to provide up to 4 L/Min of flow.

Earlier stage heart failure patients have unique clinical needs, it is important that the MiVAD have a high safety profile and have a low incidence of adverse events. Due to the lower limit of circulatory assistance provided and due to the device's anticipated smaller size, it is possible for this device to be placed further away from the natural heart with a simpler, more minimally invasive operation than a full-support VAD, anticipated to be in the cardiac catheterization setting with surgical support.

The figure depicts the anticipated placement of the AA battery-sized MiVAD in the human chest. The MiVAD will be placed in a subcutaneous pocket much like today's defibrillators and pacemakers. The device as shown is expected to draw blood from the left atrium and pump it into the right subclavian artery.

The MiVAD is based on the PediaFlow VAD. Both devices utilize a miniaturized version of the magnetic levitation technology used in the Levacor VAD. Use of this MagLev technology is anticipated to provide the safety, durability and performance profile needed by the intended patient population.