HeartWare’s technology platform allows for miniaturization without compromising clinical performance. HeartWare’s Advanced Product Development team is dedicated to improving upon this revolutionary technology platform by developing a family of further miniaturized devices, implantable by progressively less invasive surgery. We believe that by reducing the invasiveness of the implant procedure, we have the potential to dramatically expand the use of mechanical circulatory support systems, to help a greater population of heart failure patients, and to access patients at an earlier stage of their disease progression.
In addition to the focus on pump miniaturization, HeartWare is also developing fully implantable electronics systems based on Transcutaneous Energy Transfer (TET) technology.
HeartWare’s MVAD Pump is a continuous axial flow pump, approximately one-third the size of the HVAD® Pump. The MVAD Pump is based on the same proprietary “contactless” impeller suspension technology used in the HVAD Pump, with its single moving part held in place through a combination of passive-magnetic and hydrodynamic forces. The MVAD Pump is designed to support a wide range of flows to enable both full and partial support capability. Additionally, we expect MVAD’s small size and wide range of flows to enable support of smaller patients and those with right ventricular failure.
Implantation of the MVAD Pump may require less invasive surgery than the median sternotomy typically used to implant currently available ventricular assist devices. By reducing the invasiveness of the surgery, HeartWare expects to treat a greater proportion of heart failure patients and to access patients at an earlier stage of their disease progression.
The MVAD Pump is targeted to begin human clinical trials in 2013.
In parallel with HeartWare’s pump development activities, significant R&D effort is allocated to the enhancement of HeartWare’s electronics and controller technologies. A key focus is the development of a fully implantable system based on Transcutaneous Energy Transfer (“TET”) technology.
TET technology enables a fully implanted battery pack to be periodically recharged using inductive coupling across the skin. This will allow implantation of the complete system, including batteries and controllers, and will eliminate the current need for a percutaneous driveline to a permanently connected controller. The aim of the program is to enable patients implanted with a HeartWare device to be free of any external charging system for up to several hours at a time.
By eliminating the percutaneous driveline, HeartWare expects to improve the adverse event profile extending the longevity of the therapy. We believe substantial quality of life improvements will increase adoption of the therapy among patients and referring cardiologists.
The fully implantable platform is being developed in collaboration with Dualis Medtech GmbH, a company spun out of the German Aerospace research organization, the DLR.
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