Veteran Team Behind Multiple Approved Cardiovascular Devices Reunites to Target Structural Heart Disease with New IPO Filing

In 2005, Professor Horst Sievert of the Cardiovascular Center in Frankfurt, Germany, proposed the concept of structural heart disease. As a new concept in the field of cardiovascular diseases, structural heart disease refers to any abnormality in cardiac structure. After years of development, it is now generally believed that structural heart disease includes congenital or acquired cardiovascular diseases characterized primarily by abnormalities in the structure of the heart and great vessels, such as traditionally defined congenital heart diseases, valvular heart diseases, cardiomyopathies, and others.

Nowadays, interventional therapy has become the primary treatment modality for patients with structural heart diseases, such as transcatheter valve interventions, left atrial appendage closure, and interventional treatments for cardiomyopathy and heart failure. Due to its advantages—including minimal invasiveness, low risk, fewer complications, and shorter hospital stays—interventional therapy holds broad prospects for development in China.

China boasts a vast patient market, yet the domestic interventional device industry started relatively later than its international counterparts. For numerous R&D-driven companies, structural heart disease is hailed as the sunrise sector of cardiovascular medicine, where rapid development brings both opportunities and challenges. Many institutions at home and abroad are seizing these opportunities and confronting the challenges head-on. Among them, Wuhan Vickor Medical Technology Co., Ltd. (hereinafter referred to as "Vickor") specializes in developing a series of interventional treatment solutions for structural heart diseases, possessing extensive experience in the R&D and clinical application of interventional devices for such conditions.

Vickor Medical, established in 2018, currently offers the D-shant Atrial Shunt Device and the Patent Foramen Ovale (PFO) Occluder, which are used to treat heart failure and cryptogenic stroke, respectively. These two products are representative interventional therapies for structural heart disease. Shang Xiaoke, founder of Vickor Medical, stated, “Product innovations in PFO occluders and atrial shunt devices are largely driven by clinical needs, aiming to address the many pain points and limitations associated with the clinical application of existing products.”

China has approximately 20 million patients with heart failure. Heart failure is the common late-stage manifestation of various chronic structural or non-structural heart diseases. Despite intensified pharmacological therapy, the five-year mortality rate remains as high as 30–70% across all types of heart failure patients. Consequently, numerous research institutions have turned their attention to device-based therapies.

Shang Xiaoke stated, “Currently, apart from cardiac resynchronization therapy, various device-based treatments for heart failure are still in their infancy worldwide. Due to high technical barriers, lack of domestic production, and narrow indications, their clinical adoption remains limited. The atrial shunt device is currently the most promising medical device for treating heart failure.”

He stated, “The manufacturing structure of atrial septal shunt devices is not complex, and their indications are extensive. With the emergence of more evidence and positive results from long-term follow-up in clinical trials, the potential for widespread clinical application and broad adoption is considerable. Atrial septal shunt devices may become the heart failure device therapy products with the most promising application prospects and market value in the future.”

Atrial Septal Shunt Devices: Originating from Dr. Lützbach, who proposed a novel concept in 1916 that atrial septal defects might offer beneficial hemodynamic effects for patients with heart failure. With increasingly in-depth research in this field in recent years, interatrial shunt devices have emerged.

Shang Xiaoke stated, “Over the past three years, authoritative journals in Europe and the United States have repeatedly reported on prospective studies of implantable atrial shunt decompression devices in small cohorts of heart failure patients, demonstrating favorable clinical outcomes. Notably, this represents a pioneering device-based therapy for patients with heart failure with preserved ejection fraction (HFpEF). Two-year follow-up results in patients who underwent implantation of an atrial septal shunt device showed increased exercise tolerance, low rates of rehospitalization, and significant improvements in quality of life and prognosis. Furthermore, the procedure has a high success rate, with very low rates of device- and procedure-related complications and mortality.” 

Vickor Medical’s D-shant shunt was developed by a team of experts. Shang Xiaoke told reporters, “The development of the atrial shunt represents the collective efforts of numerous renowned cardiac surgeons, cardiologists, and structural heart disease specialists in China, as well as top engineers in the fields of metal braiding and cutting. The product has completed a three-month observational period in preclinical animal studies. After three months, the device demonstrated good apposition to the interatrial septum with complete endothelialization. The shunt opening in the interatrial septum remained patent, continuing to provide atrial decompression, thereby alleviating symptoms caused by heart failure.”

Shang Xiaoke believes that Vickor’s shunt devices offer the following advantages:

1. The D-shant atrial shunt is positioned primarily for the domestic market, with the international market as a secondary focus. It will first gain traction in provincial-level major hospitals to drive adoption in surrounding cities, ultimately penetrating county-level hospitals, thereby capturing the domestic market of 20 million heart failure patients.

2. The lead investigators for the D-shant Atrial Shunt Device are the Chair of the Heart Failure Committee of the Cardiology Branch and the Chair of the Heart Failure Committee of the Cardiovascular Surgery Branch of the Chinese Medical Association.

3. Extensive participation by experts from the Early-Stage Structural Heart Disease Committee of China, with early market positioning initiated during the R&D phase.

4. The D-shant atrial shunt has low production costs and high cost-effectiveness.

5. The D-shant atrial shunt device utilizes a conventional interventional technique, combining atrial septostomy with atrial septal defect closure. The procedure typically takes no more than five minutes for an interventional cardiologist to perform. Physicians will find the D-shant device familiar and do not need to dedicate additional time to learning its operational techniques.

6. Overseas shunt devices generally resemble the D-shunt atrial shunt in design, with robust evidence supporting their efficacy and a favorable safety profile devoid of major complications.

Shang Xiaoke stated, “The product registration testing and biological evaluation of the D-shant atrial shunt have been officially submitted for inspection, and subsequent clinical trials will be launched soon.”

“To safeguard the uniqueness, academic integrity, and market exclusivity of our company’s products, Vickor has already filed seven invention patents for this product during the technical research and development of the shunt device,” introduced Shang Xiaoke. The experimental research papers, review articles, and Meta-analyses related to this study have all begun to be drafted and submitted for publication. Following the launch of the First-in-Man (FIM) study in November, an expert consensus on heart failure shunt devices will be drafted in December by members from the Structural Heart Disease Group of the Cardiology Branch of the Chinese Medical Association, the Structural Heart Disease Professional Committee of the Cardiology Branch of the Chinese Medical Doctor Association, the Structural Heart Disease Group of the Cardiovascular Surgery Branch of the Chinese Medical Doctor Association, the National Center for Cardiovascular Diseases’ Young Committee on Structural Heart Disease, and the Asia-Pacific Young Committee on Structural Heart Disease.

In 2017, the results of several large-scale randomized controlled clinical trials were published in The New England Journal of Medicine, demonstrating that patent foramen ovale (PFO) closure is superior to long-term pharmacological therapy for the secondary prevention of cryptogenic stroke.

Shang Xiaoke introduced: “Currently, the consensus among domestic experts holds that the primary indication for closure is cryptogenic stroke or transient ischemic attack (TIA) combined with patent foramen ovale (PFO). Interventional closure is recommended for patients with significant right-to-left shunting, other anatomical high-risk factors, clinical high-risk factors, recurrent events, or confirmed venous system thrombosis.”

“Meanwhile, interventional closure is also recommended for patients with typical migraine with aura, chronic or refractory migraine, decompression sickness in divers, and platypnea-orthodeoxia syndrome who have a patent foramen ovale (PFO) with significant right-to-left shunting. The PFO occluder primarily targets these patient categories, with a potential population of tens of millions in China.”

Vickor’s patent foramen ovale (PFO) occluder and its atrial shunt device for heart failure treatment were initiated for research almost simultaneously. Shang Xiaoke stated, “We have made numerous innovative improvements to the PFO occluder, including an enhanced double-disc interlocking structure, a rivet-free braiding technique, and a polymer nanocoating technology that reduces the release of toxic nickel ions. Additionally, we have expanded the product specifications to include 12 variants.”

“In animal experiments, our product demonstrated favorable performance, such as significantly lower nickel ion release in the blood compared to existing occluders, and no need for postoperative antithrombotic medications like aspirin. These innovations are largely driven by clinical needs, offering significant advantages and addressing many of the pain points and limitations associated with the clinical application of current products.”

“Currently, only two patent foramen ovale (PFO) occluders have been approved by the FDA. These are the safest and most mature products, validated through extensive clinical trials. Our product continues to utilize the most established nickel-titanium alloy braided technology, offering stable performance and a reliable safety profile. Consistent with the design lineage of congenital heart disease occluders, it is readily adopted and accepted in clinical practice.”

“Our product’s defining feature is identifying and addressing design flaws in existing products. Stripping away gimmicks, we aim to deliver a truly superior medical device, with its core principles summarized in twelve Chinese characters: ‘Return to clinical practice, ensure structural stability, and achieve secure occlusion.’” Shang Xiaoke revealed that the product is expected to take two years to reach the market.

Vickor Medical’s patent foramen ovale (PFO) occluder has completed animal studies and registration testing, and is currently preparing documentation for clinical ethics approval, with clinical trials expected to commence shortly. Shang Xiaoke stated, “The PFO clinical trial is anticipated to enroll 144 subjects across 4–5 centers in China, led by the Head of the Structural Heart Disease Group of the Chinese Society of Cardiology under the Chinese Medical Association, with participation from West China Hospital of Sichuan University, Wuhan Union Hospital, and Wuhan Tongji Hospital.”

Shang Xiaoke also introduced the project team: “The primary medical and technical guidance, as well as R&D support throughout the development process, were provided by the company’s founding shareholders. The company’s Technical Director is one of the earliest pioneers in the field of occluder devices in China. The head of regulatory registration and listing previously worked at a well-known domestic peer company, where he was responsible for the registration and filing of multiple products, and is now a renowned senior expert in regulatory affairs within this field.”

The founding team of Vickor Medical consists of top-tier domestic talents from various fields within the medical industry. Shang Xiaoke introduced, “One of the company’s founders was recognized as one of the Top Ten Outstanding Young Cardiac Surgeons in China (awarded in 2016), and the core engineer is a pioneer among the earliest founders of occlusion devices in China. The founding team comprises 12 members, with more than two-thirds serving as master’s or doctoral supervisors. The team includes experts in interventional procedures for structural heart disease, cardiac surgery, cardiology, R&D of metallic medical devices, and registration of Class III medical devices.”

Shang Xiaoke believes that the team's most distinctive feature is its direct integration of medical and technical expertise, forming a collaborative industry-academia-research unit. He stated, "The Vickor Medical team has led the domestic registration and market launch of multiple products and possesses extensive R&D experience in interventional devices such as stents."

Regarding future plans, Shang Xiaoke stated, “Vickor will continue to focus on structural heart disease and develop related supporting devices to address clinical challenges.” He believes that “structural heart disease is a sunrise industry within interventional cardiology, with products evolving rapidly. Our company’s primary R&D efforts are also concentrated in this field. In addition to PFO occluders and atrial shunt devices, projects the company is highly likely to initiate in the near future include aortic turbine-powered devices, transcatheter valve replacement and repair products, and cardiac intervention suturing devices.”

At the end of the interview, Shang Xiaoke stated, “The localization of medical device manufacturing is a major trend. For enterprises, fully leveraging policy dividends to alleviate the growing pressure of global market competition will facilitate rapid growth. However, we must also clearly recognize the gap between domestic companies and top-tier international firms in terms of technical strength and innovation capabilities. To succeed, one must be strong oneself. In addition to introducing and learning from foreign technological concepts, enterprises need to fully integrate the characteristics of Chinese patients into their R&D efforts, design and develop high-quality products suited to the domestic market, pursue an independent path of innovation, drive continuous industry development, and gradually achieve world-class technological standards.”