CARMAT Announces a New Commercial Implant of Its Aeson® Artificial Heart at University Medical Center Schleswig-holstein in Kiel, Germany
27 August 2021 - 7:00AM
Business Wire
Regulatory News:
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and
developer of the world’s most advanced total artificial heart,
aiming to provide a therapeutic alternative for people suffering
from end-stage biventricular heart failure, today announces the
third implant of its Aeson® bioprosthetic artificial heart in a
commercial setting.
This new commercial implant of the Aeson® device was performed
by Prof. Assad Haneya and his team of the Department of
Cardiovascular Surgery at University Medical Center
Schleswig-Holstein (UKSH) in Kiel (Director: Prof. Jochen Cremer).
With 14,000 employees in over 85 clinics and institutes, UKSH is
one of the largest medical care centers in Europe and the first
training provider in Schleswig-Holstein. UKSH in Kiel is recognized
as one of Germany’s leading heart centers with a history of
thoracic transplantation for several decades. It provides maximum
medical care in this federal state and guarantees medical-technical
care at the highest level, especially for patients who require
highly differentiated diagnosis and therapy.
Prof. Assad Haneya, Director of the Transplantation and
Mechanical Circulatory Support Program at UKSH, declared: “We
are pleased to have successfully implanted the CARMAT TAH in our
center last week. The patient who received the device suffered from
severe end-stage biventricular heart failure and he was eligible to
an urgent heart transplant. During the last weeks, we noticed a
further deterioration with signs of a beginning multi-organ failure
and the use of Aeson® was a natural choice.”
Dr. Bernd Panholzer, Director of Cardiovascular Intensive
Care Unit, added: A few days after the procedure, the device is
providing all the necessary support and the patient is recovering
well. Since the device has some key characteristics similar to a
real heart, such as pulsatility, hemo-compatibility and self
regulation, we expect to meet the needs of many other patients
placed on the waiting lists with this new type of therapy.”
Stéphane Piat, Chief Executive Officer of CARMAT,
concluded: “We are proud that University Medical Center
Schleswig-Holstein, one of the largest in Germany and even in
Europe in terms of the use of mechanical circulatory support, has
chosen Aeson® as a treatment option for this critically ill
patient. I would like to thank Prof. Assad Haneya and his teams for
their trust and our technical staff for the support during the
entire process. We are experiencing growing interest in our therapy
and are pursuing its commercial deployment in Europe as
planned.”
●●●
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/20210826005634/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 94
carmat@newcap.eu
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