Carmat
The Era of Bioprosthetic Artificial Hearts

Organ scarcity is a permanent challenge of the heart transplantations. Only a minority of patients receive heart transplants, even though more than thousands of patients die waiting. The challenge is not always an imbalance between the demand and distribution of viable organs. More often than not, the problems stem from the limited donor supply due to medical, social, and moral factors. To overcome this chronic shortage of donor organs for heart transplantation, Alain Carpentier—a globally renowned cardiovascular surgeon—dedicated his life to the development of auto-regulating, bioprosthetic artificial heart.

In the early ’90s, Carpentier started his quest to build a device that mimics a human heart. However, at that time, the healthcare industry lacked the technology to create a fully implantable self-regulatory artificial heart with perfect pulsatility and complete biocompatibility. When hit by this technical speed bump, he joined forces with Jean-Luc Lagardère, the founder of Matra Defense, an aerospace and weapons manufacturer. By combining Carpentier’s expertise in biomaterials and pericardial valves and Matra’s proficiency in complex electronic boards used in missile systems, they managed to build a fully-functional artificial human heart. Their joint research efforts led them to establish Carmat, the world’s most advanced artificial heart manufacturer.

Carmat’s bioprosthetic self-regulated artificial heart is a ground-breaking innovation. This medical marvel is an amalgamation of mechanics from the aerospace industry, electronics from missile systems, and the knowledge of biologics. The incorporation of biologics makes Carmat’s artificial heart the only device made of biocompatible materials to reduce thromboembolic risks.

It also uses volumetric pumps that move the actuator fluid from a flexible external bag, activating the hybrid membranes and allowing blood to enter and exit the chambers. Moreover, the speed and rotation direction of the volumetric pumps adapts every two milliseconds to deliver calculated pulsatile flow. And, the sensors embedded in the device measure the in-flow pressure per millisecond to calculate the blood flow requirement. But, what makes this device even better is its extremely low rejection rates from a patient’s body resulting in no complications, such as stroke due to biocompatibility issues, or no gastrointestinal bleeding and percutaneous cable infection. “We offer a physiological, artificial heart which is a viable alternative to a human heart,” says Stephane Piat, CEO of Carmat.

We offer a physiological, artificial heart which is a viable alternative to a human heart

He further adds, “Our mission is to save lives and improve the quality of life in patients with advanced heart failure and overcome the shortage of donor organs for heart transplantation.” With this mission at its core, Carmat presented its preclinical data on haemocompatibility at the 25th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in 2011. In the same year, Carmat received approval from the French ethical research committee (Comité de Protection des Personnes—CPP), followed by authorization from the National Agency for the Safety of Medicines and Health Products (ANSM) to begin clinical trials in France in 2013. From the clinical trials, the 13 patients that received the transplant showed a 73 percent survival rate six months after the procedure. Based on this first patient cohort results, Carmat is working relentlessly to increase the survival rate.

With such phenomenal results, Carmat’s goal is to commercialize the device in Europe with a Certification (CE) mark. Carmat is also looking to start a feasibility study in the U.S. “Our artificial heart holds huge promise for patients suffering from advanced heart failure, and we are all set to make it available to them,” concludes Piat.