July 4th 2019
• 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.”