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Frequently Asked Questions
- What is the Arrow LionHeartTM left ventricular
assist system?
The Arrow LionHeart™ LVAS is designed as destination therapy
for patients and represents a significant advance in mechanical
circulatory assist technology. The device has no lines or cables
protruding through the skin to power the system, thus eliminating
a potential source of patient infection. It is fully implanted in
the body and does not replace the heart, but assists in the
pumping function of the heart’s left ventricle. The device
operates with an energy transmission system that does not require
puncturing the skin.
- What is meant by "destination therapy"?
"Destination therapy" indicates that a device is intended to be
the primary therapy that is applied over an extended period of
time. It is not planned to be replaced by an alternate therapy. In
this case, the Arrow LionHeart™ LVAS is an implanted destination
therapy system that is intended to assist severe congestive heart
failure patients who are unresponsive to medical therapy and who
are considered ineligible to receive a heart transplant.
Importantly, the Arrow LionHeart™ LVAS is not a
temporarily-implanted device for patients awaiting a heart
transplant.
- What is unique about the Arrow LionHeartTM LVAS as
compared to other LVAS devices?
The Arrow LionHeart™ LVAS is the first
fully-implantable left ventricular assist system with no
lines or cables coming through the skin to power the
device in clinical use. It is also the first fully
implantable "alternative" for patients ineligible for
heart transplantation. The unique features of the Arrow
LionHeart™ LVAS are expected to significantly reduce the
incidence of infections, an adverse event that frequently
results with currently available implantable systems with
drive and vent lines.
The Arrow LionHeart™ LVAS uses a transcutaneous energy
transfer system to charge internal batteries and power
the blood pump. Internal batteries allow the patient to
"de-couple" from all external components of the system,
allowing "tether free" mobility for a specified amount of
time.
The Arrow LionHeart™ LVAS utilizes a compliance
chamber to accommodate gas volume fluctuations with each
"beat" of the pump, thus eliminating the need for a
percutaneous, through-the-skin, vent tube.
The Arrow LionHeart™ LVAS is the first device to
combine implantable features successfully in a mechanical
assist system in humans. These features are expected to
significantly reduce the incidence of adverse events and
improve the quality of life for the patient.
- How is the Arrow LionHeartTM system different from
other heart-assist devices?
The main distinction between the Arrow LionHeart™ LVAS
and other heart-assist devices is that the Arrow
LionHeart™ operates with no lines or cables protruding
through the patient’s skin. This feature eliminates a
source of potentially life-threatening infections, which
may be experienced by patients who receive other
heart-assist devices.
By operating with no lines or cables protruding
through the patient’s skin, Arrow LionHeart™ recipients
can de-couple their external power sources for periods of
time allowing them to engage in normal activities, such
as taking showers and baths, without requiring special
preparations for the device.
The Arrow LionHeart™ LVAS provides a pulsatile
supplement to the patient’s natural cardiac activity, as
compared to several other heart-assist devices, which
only provide relatively pulseless support.
The modular design of the Arrow LionHeart™ LVAS allows
for the customized placement and exchange of implanted
sub-systems in each patient.
A fully automatic control algorithm in the Arrow
LionHeart™ responds automatically to a patient’s changing
demands for circulatory support, as opposed to other
heart-assist systems that are just entering the clinical
arena, which require manual adjustment of the pump speed.
- How is the Arrow LionHeartTM LVAS different from a
total artificial heart?
The Arrow LionHeart™ is fully implanted in the body and does
not replace the heart, but assists in the pumping function of the
heart’s left ventricle. Conversely, the heart is removed from the
patient’s body when replaced by a total artificial heart. Both
systems provide cardiac support to the recipient. However, the
Arrow LionHeart™ LVAS supplements the native heart’s function by
optimizing the amount of cardiac output that can be produced for
an individual patient whereas a total artificial heart pumps all
of the blood for a patient.
What will happen if the LVAS pump stops?
Because the patient retains his or her natural heart, it is
anticipated that the residual function of the heart will be adequate
to sustain circulation until the patient can be transferred to the
implant center for assistance.
Why was the first implant surgery performed in Germany rather
than in the United States?
Arrow has been pursuing regulatory approvals simultaneously in
the United States and in Europe. The process in Europe took less
time. Bad Oeynhausen, Germany was chosen as the first site to do the
implant based on its extensive experience with numerous mechanical
assist devices, and the expertise of not only the surgical team, but
also a well established post-implant support program, which enables
patients to be discharged from the hospital.
When will the Arrow LionHeartTM LVAS be available in
the United States?
The Arrow LionHeart™LVAS became clinically available in the U.S
on an investigational use basis when the FDA approved the Phase I
clinical trial in 2001.
What is the history of the Arrow LionHeartTM
development and how many patients to date have received the Arrow
LionHeartTM LVAS?
Arrow began a collaborative effort with the Department of
Surgery’s Division of Artificial Organs at Penn State College of
Medicine in 1993. Predecessors to the Arrow LionHeart™LVAS were
designed, built and tested at Penn State Hershey Medical Center over
the course of the last 30 years. The earliest designs were pneumatic
and have been used clinically in over 1,000 patients as a short-term
"bridge-to-transplant" VAD, and the current version of this
pneumatic device is still used clinically today.
In the early 1980s, work began on an electrical version of the
pump. By 1993, the research team at Penn State College of Medicine
developed a sophisticated, totally implantable left ventricular
assist system capable of providing supplemental flow to a failing
heart. Arrow then applied its medical device manufacturing expertise
to further develop, in collaboration with Penn State Hershey Medical
Center, the Arrow LionHeart™ LVAS to its present state.
See our Timeline
for more information.
Who is sponsoring the clinical trials in Europe and the United
States?
Arrow International, Inc., headquartered in Reading,
Pennsylvania.
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