Breakthrough in Heart Failure Interventional Devices: Wego Medical's Guanggu Base in China Commences Production

New Breakthrough in Heart Failure Interventional Devices: Vickor's China Optics Valley Base Commences Production

Domestic interventional devices for heart failure treatment achieve a new breakthrough.

On July 18, the new manufacturing facility of Wuhan Vickor Medical Technology Co., Ltd. was officially completed and put into production in Wuhan Optics Valley. This marks an acceleration in the mass production of the D-shant atrial shunt, independently developed and manufactured by Chinese enterprises.

According to reports, the D-shant atrial shunt is China's first interventional therapeutic device for heart failure, which completed its first human implantation in April 2020. In July 2021, the FIM study concluded, followed by the official launch of a nationwide multi-center registration clinical trial and the enrollment of the first subject.

“Heart failure is considered the only ‘final frontier’ yet to be conquered in the field of cardiovascular disease. The successful clinical introduction of the D-shant interatrial shunt device marks China’s first breakthrough in this field,” said Shang Xiaoke, Founder and Chairman of Vickor. Compared with similar international products, the D-shant interatrial shunt device is currently the only retrievable shunt device that allows for secondary intervention.

Established in July 2018 in the Wuhan East Lake High-tech Development Zone, Wuhan Vickor Medical Technology Co., Ltd. (Vickor) is an innovative medical device R&D and manufacturing enterprise dedicated to minimally invasive interventional therapies for structural heart disease and heart failure. The company’s current core products include atrial shunt devices, nano-membrane patent foramen ovale (PFO) occluders, transcatheter aortic valves, and transcatheter valve repair devices, alongside essential cardiac interventional ancillary consumables such as interatrial septal delivery systems, septal puncture systems, pre-shaped extra-stiff guidewires, and balloon catheters.

The life and health industry is one of the two major pillar industries in the East Lake High-tech Development Zone. Previously, Wang Xiangwang, Member of the Standing Committee of the Wuhan Municipal Party Committee and Secretary of the Party Working Committee of the East Lake High-tech Development Zone, pointed out, "In the modern industrial layout of Optics Valley, the life and health industry and the optoelectronics, integrated circuits, displays, smart terminals, and networks industry advance in tandem as the two leading sectors. Leading enterprises can play a pioneering role in empowering the R&D of pharmaceuticals and medical devices in Optics Valley."

Specifically, Wuhan is home to a number of industry-leading enterprises such as BGI Genomics (300676.SZ), Humanwell Healthcare (600079.SH), and Mindray Medical (300760.SZ), and features several industrial clusters including Optics Valley Bio-City, Optics Valley Health Industry Park, and the Hanyang Health Industry Park Development Zone. Among them, the biopharmaceutical sector has been selected as one of China's first national-level strategic emerging industry clusters.

Among them, the industrial agglomeration effect of Optics Valley Biocity has become evident, establishing a complete industrial chain from basic R&D to clinical applications and achieving a total industrial revenue of RMB 130 billion in 2020. Currently, over 3,000 enterprises have settled in Optics Valley Biocity, including pharmaceutical companies specializing in genetic engineering drugs and high-end chemical formulations, medical device companies focusing on high-end medical imaging and in vitro diagnostic (IVD) products, as well as a number of “Internet+” and contract research organization (CRO) service providers.

Shang Xiaoke stated, "Currently, there is not yet a single approved and registered manufacturer of Class III high-risk cardiac implantable devices in Wuhan or even the broader Central China region."

According to the introduction, the new facility features a modern GMP-compliant plant, Class 10,000 laminar flow cleanrooms, and physicochemical laboratories. It has established multiple complete production lines for structural heart disease interventional devices and associated consumables, equipped with various advanced testing and inspection equipment, forming a standardized production workflow.

To date, Vickor has filed over 40 national patents and 1 PCT patent, strategically positioning itself in the field of interventional therapy for structural heart diseases. The company successively secured cumulative investments totaling tens of millions of RMB across its angel round in January 2019, Pre-A round in October 2019, and Series A round in November 2020. A new financing round was initiated in June this year.

(Authors: Chen Hongxia, Jing Ran; Editor: Xu Xu)