Two pVAD Devices from Suzhou Xinling Maide and Shanghai Huanqing Enter NMPA's Green Channel on the Same Day

Dec 27, 2023 18:08 CST Updated 18:09

HearHill

Cardiovascular Innovation Product Developer

magAssist

Developer of Extracorporeal Artificial Heart Devices

Core Medical

Artificial Heart Series Product Developer

Source: Medical MedTalks

On December 22, the Center for Medical Device Evaluation of the National Medical Products Administration announced that two PVAD devices are proposed to enter the special review process ("green channel"). These are the interventional ventricular assist devices from HearHill and Shanghai Huanqing.

Ventricular assist devices are currently the most widely used artificial heart systems in clinical applications, which are divided into left ventricular assist devices (LVAD), right ventricular assist devices (RVAD), percutaneous ventricular assist devices (pVAD), and biventricular assist devices (BiVAD).

In terms of left ventricular assist devices (LVADs), four Chinese-made artificial hearts have been launched in China: Chongqing Yongren Heart (launched in 2019), Suzhou magAssist (launched in 2021), Tianjin Aerospace Tai Xin (launched in 2022), and Shenzhen Core Medical Technology Co., Ltd. (launched in early June 2023).

The product entering the "green channel" this time is the percutaneous ventricular assist device (pVAD), a ventricular assist device implanted via the skin. It drains blood into the arterial system through the action of a blood pump, partially or fully replacing the heart's pumping function and alleviating heart failure symptoms.

Minimally invasive interventions have the advantage of smaller incisions, and because their operational support time within the body is relatively short, they are commonly used in clinical scenarios such as acute myocardial infarction treatment and high-risk PCI surgery protection.

In the field of percutaneous ventricular assist devices (pVAD), competition in the Chinese market is exceptionally fierce. In addition to HeartHill and Shanghai Huanqing, which entered the "green channel" this month, other medical technology companies such as Xinhengrui Medical, magAssist, Core Medical, Tongling Biomimetics, Hangzhou Diyuan, and Fengkaili Medical are also making strategic moves.

Among them, the SynFlow 3.0 independently developed by magAssist completed its first implantation on August 25, 2022, successfully assisted in high-risk complex PCI surgery, and entered the special review process for innovative medical devices in early 2023.

Core Medical's CorVad interventional ventricular assist system successfully completed its first clinical trial surgery on July 24 this year, and on July 11, it passed the application for the National Medical Products Administration's special review process for innovative medical devices, entering the "green channel."

The ventricular assist device "Micro Heart Catheter Pump" from Anhui Tongling Biomimetic, entered the "green channel" on September 22, 2023. In terms of size, it holds the title of the "world's smallest artificial heart."

In terms of international evidence collection, magAssist's interventional artificial heart received the "Breakthrough Device" designation from the U.S. Food and Drug Administration in August this year, becoming the first domestically produced interventional artificial heart to receive such recognition. (End)

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