China's Smallest and Lightest Fully Magnetically Levitated Artificial Heart, Corheart®6, Officially Launched

Text｜Chen Siyuan

Editor｜Yuan Silai

Hardcore News: The world's smallest and lightest fully magnetically levitated artificial heart — Corheart®6 Implantable Left Ventricular Assist System officially launched. This artificial heart, independently developed by Shenzhen Core Medical Technology Co., Ltd., has a diameter of 3.4 cm, a thickness of 2.6 cm, and weighs approximately 90 grams. It is designed to provide hemodynamic support for patients with advanced refractory left heart failure.

The human heart is composed of four chambers, including the left and right atria and the left and right ventricles. The atria are responsible for the return of blood from the entire body, while the ventricles are responsible for pumping blood. Among them, the main chamber responsible for pumping blood to the entire body is the left ventricle. Most heart failure patients suffer from left-sided heart failure, so the research and development goal of artificial hearts has been focused on left ventricular assist devices.

To be precise, an artificial heart refers to an implantable Ventricular Assist Device (VAD), with the core component being the blood pump, which operates similarly to a mechanical pump. This auxiliary device uses mechanical methods to extract blood from the ventricle, pumps it through an artificial blood vessel into the aorta via the blood pump, and delivers the blood to organs throughout the body. The artificial heart functions like a water pump, providing continuous power and an auxiliary flow channel for blood circulation.

The research and development of artificial hearts began in the 1950s, evolving from the first generation of bionic artificial hearts using pulsatile pumps, to the second generation of functional hearts driven by axial flow pumps, and finally to the third generation of artificial hearts employing rotor suspension. In 2011, Chen Chen's team developed China’s first fully magnetically suspended artificial heart, with a thickness of 2.6 centimeters, a diameter of 5 centimeters, and a weight of less than 180 grams. This artificial heart addressed two major challenges: the size and efficiency of the blood pump, as well as the issue of blood clots.

The Corheart®6 Implantable Left Ventricular Assist System, released this time, completed product finalization in 2019, animal experiments in 2020, and received approval for the Innovative Medical Device Special Review Process in 2021, completing the first clinical implantation. In 2022, it achieved the first pediatric clinical implantation in China and successfully implanted into a 12-year-old child with heart failure in February 2023, setting new records for the youngest age and lowest weight for an artificial heart implant surgery in China. In June of the same year, it was approved for marketing by the National Medical Products Administration.

Heart failure is the end stage of various cardiovascular diseases, and the vast majority of heart failure cases begin with left-sided heart failure. According to the "Report on Cardiovascular Health and Diseases in China 2021," in 2019, cardiovascular diseases accounted for 46.74% of deaths in rural areas and 44.26% in urban areas, with 2 out of every 5 deaths attributed to cardiovascular diseases. It is estimated that there are 330 million people currently suffering from cardiovascular diseases, including 8.9 million heart failure patients. Additionally, due to the impact of COVID-19, the number of myocarditis patients has increased compared to previous years.

Artificial heart is an effective treatment for end-stage or severe heart failure patients, and it is also the only effective alternative to heart transplantation. The successful development and application of the fully magnetically suspended artificial heart bring more hope to patients with advanced refractory heart failure.

Shenzhen Core Medical Technology Co., Ltd. was established in August 2016, with its headquarters located in Shenzhen. The company is engaged in the research, development, and production of high-end innovative medical device products, such as mechanical circulatory assist devices (commonly known as "artificial hearts"). It is currently the only company in the world to achieve a comprehensive layout in the field of implantable and interventional artificial hearts.

The National Medical Products Administration (NMPA) evaluated the Corheart®6, independently developed by Core Medical, stating that "it has a simpler structure, lighter weight, smaller size, and lower power consumption. In clinical applications, it results in a smaller surgical incision, faster patient recovery, a broader applicable population, and can reduce the risk of thrombosis caused by blood pump heat."