Overview

HeartWare is developing a family of Left Ventricular Assist Devices ("LVADs") for the treatment of advanced heart failure.  Through a cadence of progressively smaller devices, implanted by progressively less invasive surgery, HeartWare expects to treat an increasing proportion of heart failure patients and to access patients at an earlier stage of their disease progression.  HeartWare's lead product, the HeartWare Ventricular Assist System, has been approved for sale in the European Union and is currently the subject of a clinical trial in the United States.   
 

An LVAD is a surgically implanted mechanical pump designed to supplement the reduced blood pumping capability of a patient's failing heart.  LVADs have been in clinical use for over twenty years, predominantly as a means of supporting, or "bridging", a patient until a donor heart becomes available.  Historically, the technical limitations of these devices have restricted their use to this relatively small "Bridge to Transplant" patient population and have limited their acceptance as a potential long-term alternative to transplantation.  HeartWare's products are designed specifically to address this long-term "Destination Therapy" indication.

Key features of HeartWare's technology platform include:

"Wearless" Suspension Mechanism

At the core of the HeartWare platform is the proprietary use of a "hybrid" system for suspending the impeller (or rotor), the only moving part within the pump.  The impeller is suspended using a combination of passive magnets and a hydrodynamic thrust bearing.  The hydrodynamic thrust bearing works by establishing a "cushion" of blood between the impeller and the pump housing.  Once power is applied to the device and the impeller begins to rotate, there are no points of mechanical contact within the pump, effectively ensuring a "wearless" system.

The elimination of mechanical bearings is expected to lead both to longer term device reliability and to a reduced risk of physical damage to blood cells as they pass through the pump. 

 

Miniaturization

The hybrid suspension system also establishes a miniaturization "path", allowing HeartWare to significantly downsize its pump technology.  The HeartWare Ventricular Assist System features a miniaturized centrifugal pump, the HVADTM pump, which is small enough to be implanted above the diaphragm in all patients.  Reduced procedural invasiveness is expected to lead to more rapid post operative recovery and improved patient outcomes.  Beyond the HVADTM pump, HeartWare is developing a family of further miniaturized pumps that will be implanted by minimally invasive surgery. 

Optimal Blood Flow Paths

A key clinical requirement for an LVAD is that it causes minimal damage to the blood in the form of either thrombus (blood clotting) or hemolysis (rupturing of blood cell membranes).

The HVADTM Pump employs a proprietary "wide bladed" impeller, designed to provide optimal blood flow paths through the system.  The HVADTM Pump also incorporates an integrated inflow cannula, ensuring proximity between the heart and the pumping mechanism.  This proximity is expected to eliminate potential points of blood turbulence or stasis through the system.