press release

CARMAT reports its 2019 half-year results and confirms its main development targets to obtain CE marking in 2020

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CARMAT announces FDA conditional approval to initiate US clinical feasibility study of its total artificial heart

  • CARMAT provided sufficient data to support the initiation of a human clinical study
  • Study to include 5 patients in selected renowned US institutions

Paris, September 12, 2019 – 6.00 pm (CEST)
 
CARMAT (FR0010907956, 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, announces that the US Food and Drug Administration (FDA) has conditionally approved[1] the Company’s Investigational Device Exemption (IDE) application to initiate a US Early Feasibility Study (EFS) of its total artificial heart.
 
The EFS protocol includes 5 transplant-eligible subjects limited to a network of 7 US renowned institutions. CARMAT will submit study documents to the Institutional Review Boards (IRB) of the selected study sites and may begin enrolling patients in the study upon the first IRB approval.
 
CARMAT is invited to present the protocol of the EFS at the 2019 symposium on mechanical support for the heart and lung of the American Association for Thoracic Surgery (AATS) on September 20, 2019 in Houston (Texas).
 
Stéphane Piat, Chief Executive Officer of CARMAT, says: “The conditional approval to start a US study marks a significant milestone for CARMAT and the mechanical circulatory support field in general. This approval demonstrates the confidence of the FDA in our ability to conduct this feasibility study and reflects the high need for a safe and efficient solution for patients suffering from biventricular heart failure while waiting for a donor heart. We have already selected potential study sites and will immediately begin the submission process with the IRBs and research contract offices.”

[1] If an IDE application is approved with conditions, the sponsor may begin subject enrollment with the number of subjects and investigational sites specified in FDA’s decision letter upon receipt of Institutional Review Board (IRB) approval.

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CARMAT receives approval to resume patient enrollment in the PIVOTAL study in Denmark

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CARMAT has presented additional interim results of the PIVOTAL study at the ASAIO conference in San Francisco

• These results have demonstrated the proper functioning of the autoregulation system on the first patient cohort
• A fifth heart transplant has confirmed the prosthesis’ efficacy for patients awaiting a donor heart
• To date, the prosthesis has reached a record individual continuous support duration of 16 months

 

Paris, July 4, 2019 – 7.30 pm CEST
CARMAT (FR0010907956, 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, announces that it has presented additional interim results of the PIVOTAL study at the American Society for Artificial Internal Organs (ASAIO) Annual Conference, which was held from June 26 to 29, 2019 in San Francisco, California.

 

CARMAT notably presented data concerning autoregulation, one of the bioprosthesis’ unique characteristics that enables the blood flow being automatically adapted to the patient’s requirements thanks to the use of intelligent control algorithms and integrated sensors. All the patients in the first cohort successfully benefited from this autoregulation as soon as they were implanted, leading to immediate and lasting hemodynamic recovery providing the optimal conditions to restore their vital functions. Autoregulation’s principles and responsiveness require a negligible number of adjustments enabling doctors to focus on the clinical monitoring of their patient. After approximately 8 days of intensive care followed by a standard rehabilitation process, the patients were able to go home less than 2 months after the implant. Thanks to the CARMAT prosthesis, these patients have spent around 70% of their time at home with a quality of life allowing them to carry out normal everyday activities.

 

Moreover, another heart transplant was successfully undertaken within the framework of the PIVOTAL study, thus taking to 5 the number of patients who have received a donor heart after benefiting from the CARMAT prosthesis’ support for a number of months. To date, the prosthesis has achieved, within the framework of the PIVOTAL study, a record 16 months of individual support, and 6 years 3 months of cumulative support in the 11 patients implanted.

 

Stéphane Piat, Chief Executive Officer of CARMAT, says: “These positive additional results furtherstrengthen our confidence in the ability of the prosthesis to offer a safe and efficient solution to patients suffering from biventricular heart failure who currently face a therapeutic impasse. We are particularlypleased with the autoregulation results, which corroborate one of the fundamental design features of our prosthesis. Given the 100% transplant success rate and the support provided by the prosthesis to date, CARMAT is proving its ability to meet the requirements of patients awaiting a heart transplant and the increasing number of those who are not on or not eligible for the heart transplant waiting list. From an operational perspective, our new manufacturing processes are in place and we are still aiming to resume implants by the end of the third quarter of 2019.

Slideshow presentation at ASAIO 2019

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CARMAT announces the resumption of production of prostheses for the PIVOTAL study

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CARMAT announces a delay in the resumption of production of prostheses for the PIVOTAL study

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CARMAT: the Shareholders’ Meeting approves all of the resolutions supported by the Board of Directors

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CARMAT to present the positive interim results of the first part of the PIVOTAL study at the 39th ISHLT annual meeting in Orlando, Florida

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