First-in-human novel valveless artificial heart
implanted in a patient with end-stage heart failure as a bridge to
heart transplant
The Texas Heart Institute (THI) and BiVACOR®, a clinical-stage
medical device company, announced today the successful
first-in-human implantation of the BiVACOR Total Artificial Heart
(TAH) as part of the U.S. Food and Drug Administration (FDA) Early
Feasibility Study (EFS) on July 9, 2024. BiVACOR’s TAH is a
titanium-constructed biventricular rotary blood pump with a single
moving part that utilizes a magnetically levitated rotor that pumps
the blood and replaces both ventricles of a failing heart.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240725893070/en/
BiVACOR Total Artificial Heart attached
to Mock Circulation Loop for Pump Hydraulics Performance Testing
with Daniel Timms, PhD, Founder & CTO (Photo: Business
Wire)
The first-in-human clinical study aims to evaluate the safety
and performance of the BiVACOR TAH as a bridge-to-transplant
solution for patients with severe biventricular heart failure or
univentricular heart failure in which left ventricular assist
device support is not recommended. Following this first
implantation completed at Baylor St. Luke’s Medical Center in the
Texas Medical Center, four additional patients are to be enrolled
in the study.
“The Texas Heart Institute is enthused about the groundbreaking
first implantation of BiVACOR’s TAH. With heart failure remaining a
leading cause of mortality globally, the BiVACOR TAH offers a
beacon of hope for countless patients awaiting a heart transplant,”
said Dr. Joseph Rogers, President and Chief Executive Officer of
The Texas Heart Institute and National Principal Investigator on
the research. “We are proud to be at the forefront of this medical
breakthrough, working alongside the dedicated teams at BiVACOR,
Baylor College of Medicine, and Baylor St. Luke’s Medical Center to
transform the future of heart failure therapy for this vulnerable
population.”
Daniel Timms, PhD, Founder and Chief Technology Officer of
BiVACOR said, “I’m incredibly proud to witness the successful
first-in-human implant of our TAH. This achievement would not have
been possible without the courage of our first patient and their
family, the dedication of our team, and our expert collaborators at
The Texas Heart Institute. Utilizing advanced MAGLEV technology,
our TAH brings us one step closer to providing a desperately needed
option for people with end-stage heart failure who require support
while waiting for a heart transplant. I look forward to continuing
the next phase of our clinical trial.”
Heart failure is a global epidemic affecting at least 26 million
people worldwide, 6.2 million adults in the U.S., and is increasing
in prevalence. Heart transplantations are reserved for those with
severe heart failure and are limited to fewer than 6,000 procedures
per year globally. Consequently, the U.S. National Institutes of
Health estimated that up to 100,000 patients could immediately
benefit from mechanical circulatory support (MCS), and the European
market is similarly sized.
The successful implantation of BiVACOR’s TAH highlights the
potential of innovative technologies to address critical challenges
in cardiac care, such as long transplantation waitlists. BiVACOR
and The Texas Heart Institute remain committed to advancing the
field of cardiac medicine and improving outcomes for patients
worldwide.
About the BiVACOR Total Artificial Heart
The BiVACOR TAH represents a paradigm shift in artificial heart
design. The size of the BiVACOR TAH is suitable for most men and
women (Body Surface Area >1.4 m2). Despite its small size, the
BiVACOR TAH is capable of providing enough cardiac output for an
adult male undergoing exercise. Using magnetic levitation
technology, the same principle used in high-speed trains, the
product features a unique pump design with a single moving part: a
magnetically suspended dual-sided rotor with left and right vanes
positioned within two separate pump chambers, forming a
double-sided centrifugal impeller that propels blood from the
respective pump chambers to the pulmonary (lung) and systemic
(body) circulations. The TAH has no valves or flexing ventricle
chambers, with MAGLEV making pulsatile outflow possible by rapidly
cycling the pump's rotor. The non-contact suspension of the rotor
via MAGLEV is designed to eliminate the potential for mechanical
wear and provide large blood gaps that minimize blood trauma,
offering a durable, reliable, and biocompatible heart
replacement.
About BiVACOR®
BiVACOR® is a clinical-stage medical device company pioneering
the development of a long-term therapy for patients with
biventricular heart failure. Under the expert direction of its
founder and TAH inventor, Daniel Timms, PhD, and the guidance of
two luminaries in cardiovascular surgery, William E. Cohn, MD, and
O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an
FDA-approved first-in-human EFS. Headquartered in Huntington Beach,
California, with clinical offices in Houston, Texas, and
international offices in Gold Coast, Australia, BiVACOR is
committed to addressing the global unmet need of patients with
end-stage heart failure awaiting transplant by providing the next
generation of life-extending solutions. For more information, visit
bivacor.com.
About The Texas Heart Institute®
The Texas Heart Institute (THI) is an independent, nonprofit
organization with the mission of improving cardiovascular health
today through trailblazing research, thought leadership, education,
and patient care. Located within the Texas Medical Center in
Houston, Texas, and founded in 1962 by renowned cardiac surgeon Dr.
Denton Cooley, THI performed the first successful heart transplant
and total artificial heart implant in the United States. Since
then, its physicians and surgeons have remained recognized as
worldwide leaders in diagnosing and treating even the most complex
cardiovascular conditions. Research programs at THI continue
pushing cardiovascular science’s boundaries by translating
laboratory discovery into patient care. THI has been ranked among
the top cardiovascular centers in the United States by US News
& World Report for over 30 years. The Texas Heart Institute has
an equity ownership interest in BiVACOR. www.texasheart.org
@texasheartinstitute
About Baylor St. Luke’s Medical Center
Baylor St. Luke’s Medical Center is an 881-bed quaternary care
academic medical center that is a joint venture between Baylor
College of Medicine and St. Luke’s Health. Located in the Texas
Medical Center, the hospital is the home of the Texas Heart
Institute, a cardiovascular research and education institution
founded in 1962 by Denton A. Cooley, MD. The hospital was the first
facility in Texas and the Southwest designated a Magnet hospital
for Nursing Excellence by the American Nurses Credentialing Center,
receiving the award four consecutive times. Baylor St. Luke’s also
has three community emergency centers offering adult and pediatric
care for the Greater Houston area.
Baylor College of Medicine
Baylor College of Medicine (www.bcm.edu) in Houston is
recognized as a health sciences university and is known for
excellence in education, research and patient care. Baylor is a
top-ranked medical school and listed 20th among all U.S. medical
schools for National Institutes of Health funding and No. 1 in
Texas. Located in the Texas Medical Center, Baylor has affiliations
with seven teaching hospitals and jointly owns and operates Baylor
St. Luke’s Medical Center, part of St. Luke’s Health. Currently,
Baylor has more than 3,000 trainees in medical, graduate, nurse
anesthesia, physician assistant, orthotics and genetic counseling
as well as residents and postdoctoral fellows. Follow Baylor
College of Medicine on Facebook
(http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter
(http://twitter.com/BCMHouston).
About Texas Medical Center
Texas Medical Center — the largest medical city globally—is at
the forefront of advancing life sciences. Home to the brightest
minds in medicine, TMC nurtures cross-institutional collaboration,
creativity, and innovation among its 106,000-plus employees. With a
campus of more than 50 million square feet, TMC annually hosts 10
million patients, performs over 180,000 surgeries, conducts over
750,000 ER visits, serves close to 14,000 heart surgeries, and
delivers over 25,000 babies. Beyond patient care, TMC is pushing
the boundaries of clinical research across its extensive network of
partner institutions daily, pioneering effective health policy
solutions to address today’s complex health care issues, and
cultivating cutting-edge digital health applications and medical
devices.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240725893070/en/
Media: Inquiries related to the BiVACOR Total Artificial
Heart (TAH): Alexander Romero-Wilson, Health+Commerce (for BiVACOR)
alexander@healthandcommerce.com
Inquiries related to The Texas Heart Institute, Baylor St.
Luke’s Medical Center, and Texas Medical Center: Jon Myers, The
Texas Heart Institute jmyers@texasheart.org