The VAD of Choice

www.heartware.com

The

HVAD System difference SIMPLE

Developed with the needs of the patient & MCS team in mind, making it simple to implant, manage and learn

VERSATILE

Designed to be used in the broadest range of patients, while allowing the greatest surgical flexibility of any VAD on the market

SMART

Created to deliver instant and actionable information to help provide a clear clinical picture

Essential Part

An of every heart failure program The HVAD System is changing the way heart failure is treated due to excellent survival, low complication rates and improved quality of life. Recent publications have shown the HVAD System offers: Consistent Survival with HVAD® System vs. Projected Survival

HIGH SURVIVAL RATES Highest survival of any US BTT pivotal clinical trial1

99 94 86

30 DAY SURVIVAL 180 DAY SURVIVAL

HVAD ADVANCE (N=140) SHFM Medical Therapy# HVAD - CAP (N=242) HVAD BTT - Europe (N=50)

1 YEAR SURVIVAL

SHFM curve based on the HVAD ADVANCE population.

§

LOW COMPLICATION RATES Low rates of bleeding and infection compared to other BTT clinical trials

• Driveline infection and sepsis were very low at 0.25 and 0.23 events/patient-year, respectively5 • Extremely low rates of bleeding requiring transfusions or reoperations at 0.19 events/patient-year5 • 84% of patients were free from GI bleeding events at 1 year3 • Very low rate of device exchange for thrombus at 0.04 events/patient-year2 • Comparable rates of neurologic events to contemporary devices in both clinical trial and commercial use4 & 5

IMPROVED QUALITY OF LIFE At follow up, patients implanted with the HVAD® Pump reported significant improvements in quality of life and more than 3x the distance they were able to walk in 6 minutes5

Quality of Life Improvements 80 70 60 50

M

255

P < 0.001

40 30 20 10 0

70

P < 0.001

Day 0

Day 180

EQ-5D: Visual Analog Scale

M

Day 0

Day 180

KCCQ: Overall Summary

Slaughter et al, HeartWare ventricular assist system for bridge to transplant: Combined results of the bridge to transplant and continued access protocol trial, JHLT2013;32:675–683

Uniquely

Designed HVAD System The most proven durable centrifugal device.

PROVEN RELIABILITY WHERE IT COUNTS

99.98 %

Reliability of implanted components in clinical and commercial use7

Robust Driveline

0

Exchanges due to internal driveline fractures in

5000

implants7

Contactless Design Enhanced Blood Flow

• Magnetic & hydrodynamic bearings • Designed for reduced damage to blood cells

3 blood flow paths lead to low shear stress

Reappearance of a Normal Circadian Rhythm after HVAD Pump Implantation

Powerful and Compact • Full flow to meet patient's physiologic needs • Responsive to patient activity and hemodynamic condition

VAD Flow

10 l/min : 50 cc

6.1 6.0 5.9 5.8 5.7 5.6 5.5 5.4 5.3 5.2 5.1

Day 7 Day 30

12AM

6AM

12PM

6PM

Hours Slaughter M et al., Reappearance of a normal circadian rhythm after ventricular assist device implantation. J Card Fail 2009:15(Suppl): S51.

12PM

Accommodates the

Broadest Range

of procedures and patient types One of the most important steps in the treatment of advanced heart failure is determining which patients are candidates for a VAD and which system is right for them. Everything from body size and frame to potential changes in body composition are considerations when making the decision.

Small Frame

Large

Small

Average

PATIENT BODY TYPES

Abdominal obesity

The unique integrated inflow cannula of the HVAD Pump allows it to fit into small framed patients, yet the HVAD Pump is powerful enough to support large framed or obese patients. The pericardial placement ensures a stable position in the left ventricle even with ventricular and body changes that occur after implant.8

PORTABLE EQUIPMENT FOR AN ACTIVE LIFESTYLE Mobility

Ease of use

• Lightest weight patient system available today

• First controller with intuitive instructions via text-based display

• Simple “plug and play” adapters provide mobility at home, in the car or on the go

Minimal maintenance

• A pair of batteries provides mobile power for up to 12 hours

50

• Total weight for travel is % less than other commercially available VAD systems

21.7 LBS Competitor19

10.7 LBS HeartWare18

• No daily system checks, no battery calibration, and no power module19

Unrivaled Versatility with ease of implantation

Every patient is unique – both in terms of anatomy and physiology. This requires surgeons to evaluate and adjust their approach to ensure proven outcomes. The HVAD Pump’s novel design accommodates different patient needs by allowing for a versatile surgical approach in a simple 3-step procedure done within the pericardial space.20

THE HVAD ADVANTAGE Pericardial Placement:

Surgical Flexibility:

• Pump position stability even with changes to body habitus

• Compact design allows for alternative placement in patients with

11,12,13,14,15,16,17

• Less extensive incision

congenital heart disease

• Elimination of pump pocket

complex LV anatomy

• Driveline exit site options

previous cardiac surgery

• Elimination of a pump pocket minimizes concern about prior or future abdominal surgeries

SIMPLE 3-STEP TREATMENT Customized surgical tools and accessories facilitate a simple, 3-step implantation procedure.

1

2

“In my experience, implantation of the HVAD System is easy to perform and causes minimal surgical trauma. I also find the HVAD Pump to be suitable for implantation in the broadest range of patient types.” — Prof. Dr. med. Thomas Krabatsch

Senior Physician, Department of Cardiothoracic and Vascular Surgery The German Heart Institute, Berlin

3

Enables clinicians to more

effectively manage their patients The smart design of the HVAD System makes it simple to learn and manage for both the patient and their support team. The intelligent interface and supporting diagnostics offer MCS teams the tools and essential information they need to effectively manage their patients.

R

I

NS

T TAN

CLE A

A BETTER WAY TO LEARN, TRAIN, AND MANAGE.

• Clear and actionable instructions • Customizable alarms provide early warning of potential issues • Self monitoring controller alerts for issues

• Real time data allows the MCS team to optimize patient management

AC TIONABLE

• Historical device trends available for review as needed

• Log files provide additional information to enhance understanding of the clinical scenario and to troubleshoot patient and equipment issues10 • 24 hour support and analysis from HeartWare experts “The HVAD System not only has excellent clinical outcomes, but it is easy to use and simple for patients to learn. The user-friendly system is unique among LVAD technologies, providing valuable real-time information about pump function which can be used to optimize device performance and improve patient management.” — Jeffrey Teuteberg, MD

Assistant Professor, Heart Failure/Cardiac Transplantation Medical Director, Artificial Heart Program University of Pittsburgh Medical Center

“The HeartWare peripherals reduce training time because the controller is easy to understand. The simple connections and clear messages allow patients and caregivers to quickly gain confidence with the system.” — Laura Blue, RN, MSN, NP

VAD Coordinator, Duke University Medical Center

The VAD of

Choice

The HVAD System allows heart failure programs to treat a broad range of patients, improve patient survival and patient quality of life. This makes the HVAD System the VAD of choice for heart failure programs around the world. Learn more about why the HVAD System is an essential part of any heart failure program. Call your HeartWare representative today.

WARNING: Serious and life threatening adverse events, including stroke, have been associated with use of this device. A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation. For full prescribing information please see the IFU Instructions For Use can be found at: www.heartware.com/clinicians/instructions-use In the USA the HVAD System is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. 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. HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.

0086

HeartWare, Inc. 14400 NW 60th Avenue Miami Lakes, FL 33014 USA www.heartware.com

©2014 HeartWare, Inc. GL1003 Rev02 3/11

References 1. Aaronson KD, et al Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 2012;125(25): 3191–3200. 2. Najjar S, et al An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transpl 2014;33 (1): 23-34. Epub ahead of print 13 Dec 2013: doi:10. 1016/j.healun.2013.12.001. 3. Goldstein D, et al Gastrointestinal bleeding in recipients of the HeartWare VAD, Presentation at AHA 2013, Dallas, Texas November 2012. Manuscript submitted for publication. 4. Streuber M, et al Results of the Registry to Evaluate the HeartWare Left Ventricular Assist System (The ReVOLVE Registry) Presentation at ISHLT 2012, Montreal, Canada April 2012: manuscript submitted for publication. 5. Slaughter M, et al HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transpl 2013;32: 675–683. 6. Strueber M, et al Multi-center evaluation of an intrapericardial left ventricular assist system. JACC 2011;57: 1375-1382. 7. Data on file with manufacturer, HeartWare Inc, Framingham, MA. 8. Sorensen EN, et al Computed tomography correlates of inflow cannula malposition in a continuous-flow ventricular-assist-device. J Heart Lung Transpl 2013; 32 (6):654-657. 9. Slaughter M, et al Reappearance of a normal circadian rhythm after ventricular assist device implantation. J Card Fail 2009:15(Suppl): S51. 10. Chorpenning K, et al HeartWare controller logs a diagnostic tool and clinical management aid for the HVAD pump. ASAIO J. 2014;60: 115-118. 11. Abicht T, et al Complex HeartMate II infection treated with pump exchange to HeartWare HVAD, ASAIO J. 2013;59:188-192. 12. Gregoric I, et al Diaphragmatic implantation of the HeartWare ventricular assist device. J Heart Lung Transpl. 2011;30: 467–70. 13. Takeda K, et al Successful implantation of HeartWare HVAD left ventricular assist device with concomitant ascending and sinus of Valsalva aneurysms repair. J Artif Organs 2012;15:204–206. 14. García S, et al Successful replacement of a Heart Assist 5 ventricular assist device with a HeartWare without removal of the original sewing/attachment rings: how to do it. Interact Cardiovasc Thorac Surg. 2013;16(6): 888-889. 15. Palmen M, et al Implantation of a left ventricular assist device in patients with a complex apical anatomy. Ann Thorac Surg 2012;94: 2122-2125. 16. Morshuis M, et al A modified technique for implantation of the HeartWare™ left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interactive CardioVascular and Thoracic Surgery (2013) 1–2 doi:10.1093/icvts/ivt187. 17. Huang J, et al HeartWare ventricular assist device placement in a patient with congenitally corrected transposition of the great arteries. J Thorac and Cardiovasc Surg. 2013;145(2) e23-25. Epub ahead of print 6 Dec 2012: doi:10.1016/j.jtcvs.2012.11.008 . 18. HeartWare® Ventricular Assist System. Instructions for Use. HeartWare International, Inc., Framingham, MA, USA (11/2012). 19. HeartMate II® Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA (5/2013). 20. Wieselthaler G, et al Initial clinical experience with novel left ventricular assist device with a magnetically levitated rotor in a mult-institutional trial. J Heart Lung Transpl. 2010;29: 1218-1225.