CARMAT Announces the Second Center Implanting Its Total Artificial Heart in the United States
25 August 2021 - 7:00AM
Business Wire
The implant was performed at UofL Health -
Jewish Hospital by University of Louisville physicians within the
framework of the U.S. Early Feasibility Study
Regulatory News:
CARMAT (FR0010907956, ALCAR), the designer and developer of the
world’s most advanced total artificial heart, aiming to fulfill an
unmet medical need by providing a therapeutic alternative to people
suffering from end-stage biventricular heart failure, announces the
second center implanting its bioprosthetic artificial heart,
Aeson®, in the United States within the framework of the Early
Feasibility Study (EFS).
The implant procedure was performed by a team led by Dr. Mark S.
Slaughter, Professor and Chair of the Department of Cardiovascular
and Thoracic Surgery at the University of Louisville and UofL
Physician at Jewish Hospital, Louisville, Kentucky. UofL Health and
the University of Louisville are known for ground-breaking
cardiovascular innovation research, especially in circulatory
support technologies. Jewish Hospital is the second U.S. hospital
to implant Aeson® within the framework of the EFS. Three additional
U.S. centers are fully trained and are currently screening patients
for the study.
In accordance with the study protocol approved by the FDA, 10
transplant-eligible patients are expected to be enrolled in this
trial. The primary study endpoint is patient survival at 180 days
post-implant or a successful cardiac transplantation within 180
days post-implant. It is a staged study with a progress report of
the first 3 patients after 60 days, before the enrollment of the
next 7 patients.
Mark S. Slaughter, MD, heart surgeon at UofL Health - Jewish
Hospital and University of Louisville, and principal investigator
of the study, stated: “We are pleased to be part of the first
U.S. centers to investigate this new artificial heart technology.
This clinical study will help us determine whether the device’s
distinguishing features such as hemocompatibility and blood flow
autoregulation are beneficial to critically ill patients suffering
from biventricular heart failure who currently have very limited
treatment options.”
Stéphane Piat, Chief Executive Officer of CARMAT,
concluded: “We are honored that our device is implanted at UofL
Health – Jewish Hospital and University of Louisville, which is
recognized throughout the United States for its quality of care and
cardiovascular research. I would like to congratulate the teams at
the hospital, as well as our technical and medical staff, on this
exceptional milestone for both patients and our company.”
●●●
About CARMAT: the world’s most advanced total artificial
heart
A credible response to end-stage heart failure: CARMAT
aims to provide a response to a major public health issue
associated with heart disease, the world’s leading cause of death:
advanced heart failure. Thanks to its total artificial heart,
Aeson®, composed of an implantable bioprosthesis and its portable
external power supply system to which it is continuously connected,
CARMAT intends to overcome the well-known shortfall in heart
transplants for the tens of thousands of people suffering from
irreversible end-stage heart failure, the most seriously affected
of the 20 million patients with this progressive disease in Europe
and the United States.
The result of combining two types of unique expertise:
the medical expertise of Professor Carpentier, known throughout the
world for inventing Carpentier-Edwards® heart valves, which are the
most used in the world, and the technological expertise of Airbus
Group, world aerospace leader.
The first physiologic heart replacement therapy: given
the use of highly biocompatible materials, its unique
self-regulation system and its pulsatile nature, the Aeson® heart
constitutes a new therapeutic class - Physiologic Heart Replacement
Therapy (PHRT) – and could save the lives of thousands of patients
every year without risk of rejection and with a good quality of
life. Aeson® is commercially available in the bridge-to-transplant
indication in Europe and other countries that recognise the CE
mark. Aeson® is also currently being evaluated in an Early
Feasibility Study in the United-States.
For more information: www.carmatsa.com
●●●
Name: CARMAT ISIN code:
FR0010907956 Ticker: ALCAR
Disclaimer
This press release and the information contained herein do not
constitute an offer to sell or subscribe to, or a solicitation of
an offer to buy or subscribe to, shares in CARMAT ("the Company")
in any country. This press release contains forward‐looking
statements that relate to the Company’s objectives. Such
forward‐looking statements are based solely on the current
expectations and assumptions of the Company’s management and
involve risk and uncertainties. Potential risks and uncertainties
include, without limitation, whether the Company will be successful
in implementing its strategies, whether there will be continued
growth in the relevant market and demand for the Company’s
products, new products or technological developments introduced by
competitors, and risks associated with managing growth. The
Company’s objectives as mentioned in this press release may not be
achieved for any of these reasons or due to other risks and
uncertainties.
No guarantee can be given as to any of the events anticipated by
the forward-looking statements, which are subject to inherent
risks, including those described in the Universal registration
document filed with the Autorité des Marchés Financiers on February
24, 2021 under number D.21-0076 as well as changes in economic
conditions, the financial markets or the markets in which CARMAT
operates. In particular, no guarantee can be given concerning the
Company’s ability to finalize the development, validation and
industrialization of the prosthesis and the equipment required for
its use, to manufacture the prostheses, satisfy the requirements of
competent authorities, enroll patients, obtain satisfactory
clinical results, perform the clinical trials and achieve
commercial objectives.
Aeson® is an active implantable medical device commercially
available in Europe ONLY, CARMAT SA., CE0344. The Aeson® TAH is
intended to replace ventricles of native heart and is indicated as
a bridge to transplant in patients suffering from end-stage
biventricular heart failure (INTERMACS classes 1-4) who are not
amenable to maximal medical therapy or LVAD and are likely to
undergo heart transplant in the 180 days following device
implantation. The decision to implant and the surgical procedure
must be executed by Health Care professionals trained by the
manufacturer. Carefully read the documentation (clinician manual,
patient manual & alarm booklet) for characteristics and
information necessary for patient selection and good use
(contraindications, precautions, side effects).
In the USA, Aeson® is currently exclusively available within the
framework of clinical trials.
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version on businesswire.com: https://www.businesswire.com/news/home/20210824005793/en/
CARMAT Stéphane Piat Chief Executive Officer
Pascale d’Arbonneau Chief Financial Officer Tel.: +33 1
39 45 64 50 contact@carmatsas.com
Alize RP Press Relations Caroline Carmagnol Tel.:
+33 6 64 18 99 59 carmat@alizerp.com
NewCap Investor Relations & Strategic Communication
Dusan Oresansky Quentin Massé Tel.: +33 1 44 71 94 92
carmat@newcap.eu
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