Download HeartWare® Ventricular Assist System

HeartWare® Ventricular Assist System
An Innovation in Mechanical Circulatory Support
for Patients with Advanced Heart Failure
Pump Design
Surgical Procedure
Peripherals
The HeartWare® Ventricular Assist
System is revolutionizing treatment
for advanced heart failure. 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.
ADVANCED
Pump Design
Full Support in a Compact Device
A 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” Design
Designed 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.
Safe and Efficient Operation
Built 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.
Continued on next page
Pump Design
Surgical Procedure
Peripherals
Robust Driveline
Urethane Sheath
Constructed with conductor wires used in pacemakers, the driveline is thin and
flexible, yet maintains durability through a protective outer sheath. The multilayer assembly separates individual conductors, thereby avoiding abrasion. Clinical
experience demonstrated no driveline wire fractures.2
Silicone Lumen
Natural Physiological Response
Circadian 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.
Reappearance of a Normal Circadian Rhythm after
HVAD Pump Implantation
6100
6000
5900
ADVANCED
Pump Design (continued)
VAD Flow
5800
5700
5600
5500
Day 7
Day 30
5400
5300
5200
5100
0
6
12
18
24
Hours
Optimized Blood Flow
The 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.
Primary Flow Path
Secondary Flow Path
Tertiary Flow Path
Continued from previous page
Pump Design
Surgical Procedure
Peripherals
SIMPLIFIED
Surgical Procedure
Pericardial Implant
Designed 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 Placement
Customized 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 Ring
Simplifies attachment of the HVAD pump to the
left ventricle and creates a primary
hemostatic seal.
Pre-Clotted 10mm Outflow Graft
Increases procedural efficiency and facilitates attachment
to the aorta.
Malleable Tunneler
Enables 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.
Pump Design
Surgical Procedure
Peripherals
STATE-OF-THE-ART
Peripherals
Safe and Proven Batteries
Intuitive Controller
Sequential drain of batteries allows for at least
12 hours of patient activity and enables safe
exchange of batteries without loss of power.2,4
User-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.
No user calibration
required – batteries
reflect accurate
capacity.
Easy to understand
controller shortens
training time and
may enable patients to
be discharged sooner.
Minimal loss of initial battery capacity after
500 discharge and recharge cycles, which leads
to longer duration of use and fewer battery
replacements.1
Battery Charge Capacity After 500 Cycles
Capacity (mAh)
4,000
3,000
Lightweight Peripherals
Designed 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.
2,000
1,000
0
0
100
200
300
400
500
Cycles
Convenient DC (Auto) Adapter
Provides an additional convenient source
of portable power when traveling and
is a proven emergency backup
during electrical outages.
Pump Design
Surgical Procedure
Peripherals
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.
References
1
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.
HeartWare, Inc.
205 Newbury Street
Framingham, MA 01701
heartware.com
0086
HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare, Inc.
© 2012 HeartWare, Inc. GL1003 Rev01 9/12