HeartWare® Ventricular Assist System

An Innovation in Mechanical Circulatory Support for Patients with Advanced Heart Failure

Pump Design

Surgical Procedure

Peripherals

Full Support in a Compact DeviceA unique impeller and integrated inflow cannula allow for miniaturization of the HVAD® pump. At just 50 cc and 160 g, it can accommodate adult patients with smaller body types, yet can generate enough blood flow – up to 10 liters per minute1 – to provide life-sustaining support for patients with even the most advanced stages of heart failure.

“Contactless” DesignDesigned for reduced risk of damage to blood cells, the HVAD pump impeller is suspended through a combination of passive magnetic and hydrodynamic forces, thereby eliminating the need for mechanical bearings and resulting in a contactless system.

ADVANCEDPump Design

A miniaturized, full output device designed to be implanted in the pericardial space. The system promotes rapid pump placement and procedural simplicity.

A less invasive surgical procedure may lead to improved outcomes, while user-friendly patient peripherals promote an active lifestyle and enhanced quality of life for heart failure patients.

Safe and Efficient OperationBuilt with redundant motor stators, the HVAD pump will continue to run in the unlikely event a driveline wire breaks.1 Dual motors also increase pump efficiency, which translates into less frequent battery changes, and in turn, improved patient quality of life.

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The HeartWare® Ventricular Assist System is revolutionizing treatment for advanced heart failure.

PeripheralsPump Design Surgical Procedure

ADVANCEDPump Design (continued)

Optimized Blood FlowThe HVAD pump was hydraulically designed to actively wash all blood contacting surfaces and enhance hemocompatibility. The suspended impeller is designed to provide optimal blood flow paths through the system, and to reduce red blood cell stresses.

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Robust DrivelineConstructed with conductor wires used in pacemakers, the driveline is thin and flexible, yet maintains durability through a protective outer sheath. The multi-layer assembly separates individual conductors, thereby avoiding abrasion. Clinical experience demonstrated no driveline wire fractures.2

Natural Physiological ResponseCircadian rhythm is observed in patients and becomes more pronounced in later stages of support.3 The HVAD® pump met patients needs based on activity level.

Primary Flow Path Secondary Flow Path Tertiary Flow Path

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PeripheralsPump Design Surgical Procedure

Urethane Sheath

Silicone Lumen

Pericardial ImplantDesigned for pericardial placement, the HVAD® pump requires no abdominal dissection. The absence of a pump pocket and a less invasive procedure may lead to decreased procedural time, reduced bleeding and infection and shorter length of hospitalization.4

“Drop In” Pump PlacementCustomized surgical accessories and a novel sewing ring facilitate a simple, 3-step process for pump placement:

1 attach sewing ring,

2 core ventricle and secure pump to sewing ring, and

3 anastomose outflow graft.

Proprietary Sewing RingSimplifies attachment of the HVAD pump to the left ventricle and creates a primary hemostatic seal.

Pre-Clotted 10mm Outflow GraftIncreases procedural efficiency and facilitates attachment to the aorta.

Malleable TunnelerEnables bidirectional subcutaneous tunneling of the driveline. The flexible tunneler can be inserted from either the inside or outside of the body with the reversible handle.

SIMPLIFIEDSurgical Procedure

PeripheralsPump Design Surgical Procedure

Safe and Proven BatteriesSequential drain of batteries allows for at least 12 hours of patient activity and enables safe exchange of batteries without loss of power.2,4

No user calibration required – batteries reflect accurate capacity.

Minimal loss of initial battery capacity after 500 discharge and recharge cycles, which leads to longer duration of use and fewer battery replacements.1

Convenient DC (Auto) AdapterProvides an additional convenient source of portable power when traveling and is a proven emergency backup during electrical outages.

STATE-OF-THE-ARTPeripherals

Intuitive ControllerUser-friendly controller communicates through text and sound. A 2-line LCD screen displays pump parameters, and during alarms provides recommended troubleshooting assistance and alarm type prioritization.

Easy to understand controller shortens training time and may enable patients to be discharged sooner.

Lightweight PeripheralsDesigned to promote an ambulatory lifestyle and patient comfort, the controller and batteries together weigh just 1.5 kg. The waterproof design of the controller and battery pack provides protection from accidental exposure to fluids.

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PeripheralsPump Design Surgical Procedure

HeartWare, Inc.205 Newbury Street Framingham, MA 01701heartware.com

© 2012 HeartWare, Inc. GL1003 Rev01 9/12

HeartWare, Inc. is a leading innovator

and provider of less invasive, miniaturized

circulatory support technologies that are

revolutionizing the treatment of advanced

heart failure.

Elegant design. Simple procedure.

Innovation in circulatory support.

References1 Bench tests performed by HeartWare, Inc. Data on file.2 Clinical Report, Evaluation of the HeartWare LVAD System for the Treatment of Advanced Heart Failure, HW002, December 22, 2009.

3 Mark S Slaughter, Michael S Ising, Daniel Tamez, Gerry O’Driscoll, Neil Voskoboynikov, Carlo R Bartoli, Steven C Koenig, Guruprasad A Giridharan, Reappearance of a normal circadian rhythm after ventricular assist device implantation, HFSA 2008.

4 Data on file at HeartWare, Inc.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions prior to using this device.

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HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare, Inc.