Kossel, The First Affiliated Hospital of Wenzhou Medical University, and Vascular Cube Tripartite Signing Ceremony

Founder and CEO of Kossel Medtech: Hu Qing

Clinical Research Office, First Affiliated Hospital of Wenzhou Medical University: Zhou Ziye

Executive President of Kossel Medtech and General Manager of Haiyu: Pan Xingzhen

Department of Cardiology, First Affiliated Hospital of Wenzhou Medical University: Su Lan

Co-founder and CTO of Vascular Cube: Bowen Zhang

Founder and CEO of Vascular Cube: Hai Wu

This tripartite cooperation focuses on synergistic clinical-driven collaboration, innovative technology transfer collaboration, and platform-based product development collaboration, setting a benchmark for the integration of medical and engineering fields.

Chinese doctors invent surgical methods based on clinical practice, promoting the rapid transformation of research results; local innovative enterprises actively promote the implementation of cooperation, achieving rapid commercialization of results.The success of the Kossel collaboration not only highlights the ability of Chinese doctors to foster original innovation in clinical practice but also demonstrates the achievements of Chinese companies and research institutions in engaging in industry-university-research-medical cooperation, indicating that locally developed innovations will increasingly emerge.

Under normal physiological conditions, the beating frequency of the human heart typically ranges from 60 to 100 beats per minute. When irreversible pathological changes occur in the heart's sinoatrial node or conduction system, it can easily lead to a severe slowing of the heart rate, resulting in bradyarrhythmia.

Severe bradyarrhythmia can significantly reduce cardiac output, making it difficult to meet the blood perfusion demands of tissues and organs throughout the body. This may lead to symptoms such as dizziness, fatigue, sluggishness, palpitations, and chest tightness, and in severe cases, episodes of amaurosis or syncope.

Currently, pacemakers are one of the main treatments for bradycardia.From the perspective of technological iteration, cardiac pacing has evolved from right ventricular apical pacing to physiological pacing, making it closer to the heart's normal natural electrophysiological activity.

Traditional pacemaker leads are placed at the right ventricular apex and its surrounding areas, which are simple to operate with relatively low technical difficulty. However, studies have found that long-term high-rate pacing of the right ventricular apex can cause asynchronous ventricular contraction, increasing the risk of heart failure and atrial fibrillation. The reason for this phenomenon lies in the fact that right ventricular apical pacing is not physiological pacing, as it alters the normal electrical conduction sequence of the heart.

Under normal circumstances, the electrical excitation of the heart originates from the sinoatrial node, then sequentially passes through the atria, atrioventricular node, His bundle, left and right bundle branches, and finally reaches the ventricular myocardium, causing the heart to contract and relax in a specific order. However, during right ventricular apical pacing, the pacing electrode directly stimulates the myocardial cells at the right ventricular apex, causing them to depolarize and contract first. This leads to delayed excitation and contraction of myocardial cells in other areas, disrupting the normal sequence of ventricular electrical excitation and subsequently causing uncoordinated mechanical activity of the myocardium. This may lead to a series of complications such as mitral regurgitation, increased cardiac load, decreased cardiac function and output, ventricular remodeling, and myocardial injury.

With the advent of active fixation leads, physiological pacing has gradually emerged, providing a superior new-generation solution for cardiac pacing.

Physiological pacing includes His bundle pacing and left bundle branch pacing. Since pacing is performed at locations closer to the normal electrical conduction pathways, such as the His bundle or left bundle branch, it enables the heart's electrical activation to be closer to the physiological state.Compared with traditional right ventricular apical pacing, physiological pacing can achieve better electrical and mechanical synchrony, which is more beneficial for protecting cardiac function and has now been supported by an increasing amount of clinical evidence.

But for a long time, cardiac pacemakers and their technological updates have been basically monopolized by internationally renowned giants, and the promotion of new procedures has also been largely dominated by them. His bundle pacing, for instance, is the "Physiological Pacing 1.0 version" led by foreign enterprises and promoted globally.

Currently, well-known foreign enterprises have developed dedicated配套器械specifically for His-bundle pacing. However, due to considerations of building proprietary technical barriers and strengthening their leading position in technology promotion, these devices are exclusive and not open to the public. During the process of technology promotion, bottlenecks in their application have gradually emerged.The anatomical location of the His bundle is deep within the right atrioventricular junction of the heart. This area is spatially narrow and adjacent to complex anatomical structures, making instrument positioning difficult and requiring extremely high technical skill from the operator—mistakes can occur even with senior practitioners., which limits its promotion and application.

Based on comprehensive considerations of clinical outcomes, operational difficulty, and more, Professor Huang Weijian and Professor Su Lan's team from the First Affiliated Hospital of Wenzhou Medical University pioneered left bundle branch pacing, ushering in the "Physiological Pacing 2.0 Era."

It is reported that the renowned Chinese pacemaker electrophysiologist and recipient of the HRS Founders Award –Professor Huang Weijian, who first proposed the concept of "left bundle branch pacing" internationally,As a pioneer of this technology, he led his team and core members, including Chief Physician Su Lan and Dr. Wu Shengjie, among others, through years of research—ranging from theoretical mechanisms, definitional operations to clinical studies—making outstanding contributions to the refinement of the conduction system pacing framework.

According to incomplete statistics, in 2023, more than 80,000 patients worldwide were implanted with His-Purkinje system pacing, including 16,000 cases in China, of which 90% were left bundle branch pacing. Under the leadership of the Chinese Society of Pacing and Electrophysiology (CSPE) and the Chinese Heart Rhythm Society (CHRS), Professor Huang Weijian led the development of the world's first consensus on His-Purkinje system pacing - "Chinese Expert Consensus on His-Purkinje System Pacing," which is also the world’s first consensus focusing on left bundle branch pacing.

In recent years, thanks to the joint efforts of numerous pacing and electrophysiology experts in China, the pacing of the His-Purkinje system in our country has developed vigorously. Both in clinical practice and academic research, the quantity and quality are among the world's leading, especially the left bundle branch pacing technology.

This procedure maintains physiological pacing while compensating for the shortcomings of His bundle pacing.Its operation is simpler, with good parameters, high success rate, low pacing threshold, and can be used for most patients with pacing or synchronization needs. Its safety and clinical efficacy have been confirmed., which has now become a hot method for physiological cardiac pacing.

Left bundle branch pacing significantly reduces the difficulty of electrode implantation and the operational threshold for doctors, but due to the inability to apply commonly used 6F pacing leads to physiological pacing, the promotion and popularization of the procedure is relatively difficult.

Compared with custom-made electrodes, the team from the First Affiliated Hospital of Wenzhou Medical University prefers to use regular electrodes for left bundle branch pacing. Firstly, regular electrodes are less expensive and more affordable. Secondly, regular electrodes are abundantly available in the market and easy to obtain, whereas customized electrodes are difficult to procure. Thirdly, the development cycle for specialized electrodes is long, and patients cannot wait for an extended period. Therefore,The team believes that "ordinary electrodes + compatible guiding sheaths available on the market" will be the optimal solution to address the clinical bottleneck of left bundle branch pacing.

But the problem lies in that common electrodes are relatively thick, and there is no specialized electrode lead introducer sheath in China. Consequently, Professor Su Lan's team from the First Affiliated Hospital of Wenzhou Medical University first approached Vascular Cube. Vascular Cube is an innovative incubation platform focusing on the peripheral vascular and cardiac pacing fields, with the concept of being the engineer by doctors' side. The professionalism in sheath design and rapid response capability of the Vascular Cube team gained recognition from Professor Su Lan. After both parties swiftly completed early market research, patent layout, and technical solution verification, Professor Su Lan hoped that Vascular Cube could assist in finding a company with strategic planning in the pacing electrophysiology field, stable operation, and at the same time, a profound understanding of the subsequent clinical research academic value. After much effort, both parties eventually found Kossel Medtech. Kossel acquired the relevant patents and took charge of the subsequent iterative development, registration, and production of the K-sheath.

AndKossel also lived up to expectations by solving the problem of insufficient support during the delivery of 6F conventional electrodes, providing an innovative solution centered around the K-sheath, which has promoted the adoption of left bundle branch pacing.

K Sheath, composed of a guiding sheath, dilator, and fixation tools, can be used for left bundle branch pacing to introduce the pacing lead into the heart chamber. The guiding sheath features a gradient hardness design, which effectively enhances surgical safety. Reportedly, the K Sheath is the first sheath device in China specifically designed for left bundle branch pacing, the first domestically produced sheath that can be used for physiological pacing, and currently the only sheath on the market applicable for atrial septal use. Overall, this product has the following highlights:

Cathlink^®Electrode Lead Introducer Sheath Set

The product entered the registration process for innovative Class II medical devices in Jiangsu Province in October 2023 and received NMPA approval on January 31, 2024. The launch of K-sheath is significant in the following aspects:

First,The launch of Kossel Sheath effectively addressed the issue of lacking ideal auxiliary devices in physiological pacing surgeries., achieving a significant breakthrough in the development of suitable tools for doctors performing left bundle branch pacing procedures "from nothing to something";

Secondly,Kossel Medtech is a typical product of the integration of medicine and engineering.Kossel, at the initial stage of the K-sheath's R&D, conducted comprehensive design input, accurately capturing and understanding the frontline clinical needs. This ensured that the K-sheath not only possessed theoretical advancement but also demonstrated excellent operability and superior performance in practical use.

More importantly,Kossel Provides a Model for Empowering Clinical Practice in China's Medical Device Industry, which effectively confirms that clinical surgery safety and efficiency can be significantly improved through the integration of medical and engineering expertise along with technological innovation, driving continuous advancement in medical technology.

At the same time, the launch of the K-sheath is closely related to the multi-dimensional core competitiveness built by Kossel.At the technical levelAs a leading vascular intervention platform enterprise in China, Kossel has comprehensively laid out in the fields of peripheral intervention, cardiac electrophysiology, coronary intervention, and interventional device materials, building an advanced and powerful technology platform. After more than a decade of deep cultivation, Kossel has developed full R&D, production, and commercialization capabilities for vascular interventional devices, with substantial accumulation of core technologies.In the aspect of raw material supply chainIts subsidiary, Haiwang Medical, focuses on the development and production of medical polymer material products. It provides various tubing and a wide range of medical sheaths and catheters as system solutions in the field of interventional medical devices, achieving self-control of core raw materials and providing Kossel with solid raw material support; thirdly, the companyHigh Attention to the Integration of Medicine and Engineering and the Corresponding Standardized Management System, which enables Kossel to have a flexible and efficient mechanism for transforming achievements, realizing the rapid implementation from design concept to specific products.

"K-sheath can be compatible with all conventional active electrodes currently used in clinical practice, showing good product versatility and a broad prospect for clinical application," said Professor Su Lan from the First Affiliated Hospital of Wenzhou Medical University. "The launch of K-sheath is significant in breaking the reliance on imported devices, benefiting more Chinese patients with bradycardia. Meanwhile, we also look forward to K-sheath entering the international market to promote the global adoption of left bundle branch pacing."

Kossel Founder and CEO Hu Qing Delivers Speech at the Launch Conference

Following the tripartite signing ceremony, Kossel held the "Clinical Study Initiation Meeting on Using Lead Delivery Sheath to Assist Active Helix Electrode in Atrial Septum/Left Bundle Branch Pacing." This study plans to utilize lead delivery sheaths to assist active helix electrodes, conducting independent research targeting both the left bundle branch area and the atrial septum. A total of 20 clinical research centers across China, including the First Affiliated Hospital of Wenzhou Medical University and Fuwai Hospital of the Chinese Academy of Medical Sciences, are participating. The study will adopt a prospective, multicenter, single-arm design to evaluate the success rate of electrode implantation, aiming to reduce potential risks associated with traditional pacing methods. It seeks to systematically assess the potential of this technology for clinical application, which is expected to improve patient outcomes and enhance quality of life.

Clinical Study Kick-off Ceremony for Assisting Active Helical Electrode in Atrial Septal / Left Bundle Branch Pacing Using Electrode Lead Introducer Sheath Set

K Sheath originated from years of clinical practice in physiological pacing by Chinese doctors, and has now achieved international leadership and gained widespread recognition. With K Sheath as the starting point, Kossel successfully transformed the wisdom of Chinese clinical experts into products with both clinical and market value, creating a closed loop from clinical needs, research and development, production, to market expansion. The concept of "derived from clinical practice, serving clinical practice" runs through the entire process, making K Sheath not only meet the needs of Chinese experts but also perform excellently in clinical settings.

This three-party collaboration will further amplify Kossel's advantages in the integration of medical engineering, as represented by the K-sheath, continuously empowering the promotion of new surgical techniques and bringing higher-quality services and products to clinical practice. At the same time, this high-quality, long-term cooperation among industry, academia, research, and medicine will further deepen domestic innovation in the field of pacing and electrophysiology. The three parties will work together to create a closed loop of "clinical needs – product development – commercial promotion – clinical research," leveraging their respective strengths to precisely address clinical pain points.

The First Affiliated Hospital of Wenzhou Medical UniversityAs an internationally leading pacemaker electrophysiology clinical center, responsible for providing innovative treatment concepts, developing innovative surgical techniques, and promoting academic activities;Vascular CubeAs a device incubation platform, responsible for assisting the cardiology team of the First Affiliated Hospital of Wenzhou Medical University in innovative exploration in the field of pacing and electrophysiology, improving the development efficiency from concept to prototype, and assisting in patent layout in China and internationally as well as early-stage technical validation.KosselRelying on its full-industry-chain platform capabilities, Kossel completes rapid product development and iteration, obtains regulatory approvals in China and internationally, and implements commercialization strategies. Additionally, it supports the First Affiliated Hospital of Wenzhou Medical University in collaborating with other top clinical centers in China to conduct relevant clinical research focused on innovative surgical techniques and products.

"Kossel played a key role as a platform support in the tripartite cooperation, especially with its early investment in the core raw material R&D and production team at Haiwang Medical, which significantly accelerated the iteration speed of innovative products," said Wu Hai, founder and CEO of Vascular Magic. This was also an important reason for choosing to collaborate with Kossel.

It is reported that Kossel will actively carry out procedural training and market education, and initiate post-marketing clinical research to obtain broader and richer clinical feedback, promoting the subsequent product development and iteration. In addition, Kossel will also launch overseas market registration, strengthen exchanges with overseas clinical experts, firmly advance its internationalization strategy, and make superior surgical outcomes accessible to more patients.