Shanshi Medical Pioneers Non-Invasive, Real-Time, Continuous, and Accurate Hemodynamic Monitoring for Perioperative Patients
How to Achieve Non-invasive, Real-time, Continuous, and Accurate Monitoring of Perioperative Patients' Blood Pressure and Hemodynamics: Shanshi Delivers a Satisfactory Solution to Clinical Experts through International Cooperation and Technological Innovation.
Its core patented product, the TL-400 Non-Invasive Real-Time Blood Pressure and Hemodynamic Monitoring System, enables real-time monitoringSystemic Vascular Resistance, Stroke Volume, Continuous Cardiac Output, and a Total of 15 Hemodynamic Parameters, providing a comprehensive assessment of patient perfusion to ensure surgical safety. The system has previously obtained FDA clearance and EU CE certification.
Shanshi’s independently developed non-invasive blood pressure and hemodynamic monitoring system is not intended to replace existing invasive catheter-based products, but rather to address the clinical gap in non-invasive, real-time, continuous, and accurate monitoring of blood pressure and hemodynamics for patients undergoing non-high-risk surgeries.
Perioperative Blood Pressure Management Is a Core Competency in Anesthesiology: Prolonged Hypotension May Lead to Inadequate Perfusion of Vital Organs, Thereby Increasing the Risk of Postoperative Cardiac, Cerebral, and Renal Injury. Therefore, Anesthesiologists Must Provide Continuous Real-Time Monitoring of Patients’ Blood Pressure During Surgery to Prevent Surgical Complications and Facilitate Postoperative Recovery.
“Surgeries are categorized as major or minor, but anesthesia carries no such distinction. The risks associated with a painless gastroscopy and a surgery under general anesthesia may be comparable.”
Currently, the only method capable of real-time and accurate monitoring of blood pressure parameters is arterial cannulation; however, this invasive technique may lead to complications such as thrombosis, air embolism, pseudoaneurysm, and wound infection, and is therefore reserved for high-risk patients. In clinical practice, non-invasive cuff-based blood pressure monitoring is more commonly employed, but it cannot provide real-time, continuous measurements and compromises accuracy. Consequently, anesthesiologists are unable to accurately assess intraoperative blood pressure fluctuations, significantly increasing surgical risk.
"Shanshi" refers to the adeptness at seizing opportunities.
Addressing the global challenge of non-invasive, continuous blood pressure monitoring, U.S.-based Tensys Medical, founded in 1995, has amassed substantial technological expertise through more than a decade of research and development.Shanshi partnered with Tensys Medical in 2010., jointly participating in the research and development of non-invasive real-time arterial blood pressure monitoring systems. In clinical applications, Shanshi and Tensys Medical have achieved business synergy, continuously improving non-invasive blood pressure monitoring technology and its clinical application to better align with the physiological characteristics of the Chinese population and enhance the accuracy of monitoring parameters.
Developed through collaborative R&D by Chinese and American teams, the TL-300 non-invasive real-time blood pressure monitoring system was launched. It received FDA clearance in 2012 and is capable ofNon-invasive, real-time, continuous monitoring of the patient's blood pressure and heart rate.Subsequently, TL-300 received NMPA approval in 2013, becoming one of the most successful cases of technology transfer for internationally leading innovative medical products completed in the shortest time.
This marks a significant milestone in the development history of Shanshi.
Based on the same principle as the “gold standard” for blood pressure monitoring—invasive cannulation—the Shanshi non-invasive real-time arterial blood pressure monitoring system employs the radial artery applanation tonometry method,External pressure is applied to the radial artery to flatten it, and blood pressure monitoring values are obtained by measuring the maximum and minimum signals from the radial artery when the external pressure is proportional to the intra-arterial pressure.
When using this system, doctors place a medical sensor at the patient's radial artery, which canDetecting Subtle Blood Pressure ChangesandAutomatically Perform Horizontal Search, until the device locates the position with the strongest radial artery pulse signal. Leveraging the sensor's uniqueMemory Function, the device will automatically return to the position of highest pressure. In addition, during operation, the device continuously applies downward pressure on the sensor, placing the patient's radial artery in a slightly flattened state. At this point, when the external pressure is balanced with the intravascular pressure, the device begins monitoring.
The sensor’s automatic search and memory function not only saves medical personnel time in locating the radial artery, but also improves the accuracy of blood pressure measurement by avoiding errors caused by improper positioning.
Furthermore, since the sensor is placed on the patient’s skin surface, the arterial pressure signal is attenuated by human tissue, body fluids, and mechanical coupling. Consequently, the signal received by the sensor is lower than the actual intra-arterial pressure. Moreover, skin conditions vary among patients, and there are differences in arterial depth.
To compensate for the partial signal loss caused by tissue coupling, Tensys has spent more than two decades developingProprietary Algorithm, fully taking into account individual patient differences such as height, weight, and age.The monitoring system calculates compensation signal variables based on proprietary algorithms, tailored to the patient's aforementioned parameters, thereby achieving precision comparable to that of invasive puncture.
Shanshi: Cherishing the Time of a Season.
Since its establishment, Shanshi has been dedicated to expanding the clinical application of innovative technologies. The company currently holds 51 international invention patents and more than 20 domestic invention patents. Building on the advanced technology acquired from Tensys, Shanshi has developed its sixth-generation product, the TL-400.
Compared to the previous-generation TL-300, the TL-400 product incorporates a range of additional parameters, including cardiac output and systemic vascular resistance. Building upon non-invasive real-time blood pressure monitoring, it enables non-invasive, real-time, continuous hemodynamic monitoring.
The system can displayTrend Chart of Five Parametersand1 Real-Time Arterial Pressure Waveform, comprehensively reflecting the patient's perfusion status. Meanwhile, it can also store12-Hour Dynamic Trends、Monitoring Data from 200 Cumulative Iterations, allowing physicians to review changes in patients' vital sign parameters, which facilitates clinical research.
Due to the circulatory regulatory function of the cardiovascular system, changes in indicators such as cardiac output, systemic vascular resistance, and blood volume precede changes in blood pressure. The TL-400 system provides comprehensive hemodynamic parameters, enabling medical personnel toPredicting Trends in Patient Blood Pressure Changes, and implement symptomatic measures promptly before clinical signs appear.
To enable patients to truly benefit from comfortable and precision medicine, non-invasive, real-time, and accurate monitoring is inevitably the future direction of perioperative blood pressure and hemodynamic monitoring. In this regard, the TL-400 not only benefits perioperative patients by reducing complications and mortality rates, but also alleviates physicians’ psychological burden and reduces healthcare costs.
It is precisely due to the TL-400’s capabilities for non-invasive, real-time, continuous, and precise monitoring, as well as its advantages of ease of operation and portability, that this device was selected as essential medical equipment urgently needed for the prevention and control of the COVID-19 pandemic.
Over the past decade-plus of entrepreneurship, Bian Junjie has remained deeply immersed in the medical device sector, never ceasing his efforts toward innovation.
In 2002, Bian Junjie graduated from China Pharmaceutical University and engaged in the research and development of traditional Chinese medicine. He later started his career as a pharmaceutical representative before transitioning into pharmaceutical sales. Through his business interactions with clinicians, and drawing on his accumulated pharmaceutical knowledge and R&D experience, he developed an impulse for innovation and entrepreneurship, shifting his focus to the burgeoning medical device industry.
In 2010, he co-founded Zhejiang Shanren Medical Equipment Manufacturing Co., Ltd. with a physician friend, focusing on the research and development of double-lumen gastric tubes and related derivative products, and developedThe first dual-lumen gastric tube, whose decompression and gastric lavage effects are significantly superior to those of traditional single-lumen gastric tubes, effectively reduces the incidence of enterocutaneous fistula.. Subsequently, the company has successively developed a triple-lumen gastric tube featuring dozens of patented technologies.
“The development of medical devices is a systematic engineering endeavor, involving multidisciplinary integration—spanning hardware, software, bioengineering, and medicine—as well as comprehensive clinical application, from prototype to mass production.”
To drive superior technological innovation and address a broader spectrum of clinical needs, Shanshi has sequentially established R&D centers in Hangzhou, Shenzhen, and the United States. It has gradually assembled an R&D team comprising scientific and research talent from Germany, the United States, Switzerland, and other countries, with expertise spanning artificial intelligence, software development, clinical medicine, bioengineering, and related fields.
Oliver Goedje, M.D., Ph.D., is the Chief Scientist of the Shanshi R&D team and led the development of the non-invasive real-time arterial blood pressure monitoring system. He is also a principal founder of Tensys Medical’s hemodynamic products in the United States.Participated in the R&D of PICOO, a continuous cardiac output monitoring technology based on pulse index.. The Company has also engaged Dr. He Kongyuan, an anesthesia expert, as its Technical Advisor to provide strategic guidance for its R&D and clinical application expansion. He is an anesthesiologist at Kaiser Permanente Medical Center in Los Angeles, USA, and has been honored with the “Global Best Physician” Award by the International Anesthesia Association for two consecutive years.
Backed by a first-class R&D team, Shanshi is further developing its non-invasive real-time blood pressure and hemodynamic monitoring system.Cardiac Function Screening and Physical Examination Products Entering the Health and Wellness Sector, gradually achieving full coverage of its flagship products from in-hospital to out-of-hospital settings, and from intraoperative to home-based care. By predicting users' blood pressure trends and the degree of arterial stiffness, it enables end-to-end care across scenarios ranging from hospitals and health checkup institutions to home-based wellness and rehabilitation.Building a Closed-Loop Care System for Hemodynamic Monitoring。
“Bridging the Last Mile of Healthcare Services. Hemodynamic monitoring is a long-term, continuous process, especially for patients with heart failure. If home-based monitoring can be achieved, preventive measures can be taken in advance, potentially reducing the need for frequent hospital visits. This would not only alleviate the suffering of postoperative patients but also effectively reduce national medical insurance expenditures.”
Born in a rural area of Henan Province, Bian Junjie holds a special affection for his hometown. Coinciding with the Henan provincial government’s investment promotion campaign in Hangzhou, he decided to invest in his home region to support Henan’s economic development, establishing Zhejiang Shanshi Biological Medical Devices (Shangqiu) Co., Ltd. in 2012.
Unlike the “rural-encircling-cities” strategy adopted by most domestic companies, Shanshi has pursued a top-down approach: first establishing clinical and academic benchmarks, then expanding its coverage and gradually extending its presence to the grassroots level.
To date, Shanshi has installed nearly 2,000 units of its non-invasive, real-time arterial blood pressure and hemodynamic monitoring systems in the market. The products have been adopted by top-tier (Grade III Class A) hospitals such as West China Hospital, Peking Union Medical College Hospital, PLA General Hospital (301 Hospital), and the First Affiliated Hospital of Zhengzhou University. Furthermore, the companyEstablished over 100 benchmark Grade A tertiary hospitals across 28 provinces and regions in China, covering multiple clinical departments including neurosurgery, anesthesiology, and gastroenterology.。
“For a company to vigorously develop medical device products, it must possess four core elements: product innovation capability, marketing and promotion capability, government affairs capability, and financial investment strength. The market promotion and mass commercialization of medical device products are the result of the interplay of various market factors, posing high barriers in terms of product application, market adoption, reimbursement and pricing, and capital investment. Many industry peers believe that surviving today’s R&D phase will allow them to see tomorrow’s sun. However, without sufficient financial strength, they will falter just before dawn.”
In 2017, Shanshi completed its Series A financing, jointly invested by Zheshang Venture Capital and TEDA Science & Technology Investment, marking a significant step in Shanshi’s commercialization journey. Shanshi is still awaiting tomorrow’s sun.