MitrAssist's SIKELIA™ Polymer-Based Transcatheter Aortic Valve System Demonstrates Excellent One-Year FIM Results and Recognized Among Top Global Cardiovascular Innovations
MitrAssist Lifesciences
Cardiovascular Innovative Medical Device R&D Manufacturer
On November 1, 2024, the 36th TCT Conference grandly opened in Washington. Numerous companies showcased new technologies and the latest evidence-based research findings, making it the focal point of the cardiovascular field. In recent years, the TCT Conference has not only exhibited groundbreaking interventional technologies but also facilitated the updates and formulation of several important guidelines, profoundly influencing the development of cardiology. Through various lectures, discussions, and hands-on demonstrations, participants can acquire cutting-edge knowledge to further improve patient outcomes and quality of life. The TCT Conference has become an indispensable platform in the cardiovascular healthcare sector, shaping the future of global cardiology. This conference covered heart valves, interventional and closure devices, drug-eluting implants, intravascular lithotripsy (IVL), and percutaneous renal denervation (RDN) and other technologies' latest advancements.
At this TCT conference, the selection was made for "the biggest cardiovascular tech stories from TCT 2024”, what is exciting is China's cardiovascular platform enterprisesMitrAssist Lifesciences' SIKELIA™ Transcatheter Polymer Aortic Valve Replacement System has been shortlisted for this list, and it is also the only Chinese medical device brand to be shortlisted.Also shortlisted are Boston Scientific's Acurate neo2 aortic valve system and Edwards Lifesciences' Evoque valve products, among others.
Notably, MitrAssist Lifesciences from China stood out at this conference, showcasing its self-developed SIKELIA™ Transcatheter Aortic Valve Replacement System. AsThe first transcatheter valve to adopt polymer leaflets, SIKELIA™ demonstrates significant advantages such as low calcification, low thrombogenicity, and high biocompatibility, with a lifespan more than twice that of existing bioprosthetic valves.。Its automated production process will significantly reduce manufacturing costs and improve product quality consistency, offering possibilities for the innovation of TAVI technology. Initial FIM study results show that SIKELIA™ excels in both safety and performance, with the potential to significantly improve outcomes for patients with severe symptoms.
MitrAssist Lifesciences CEO Wang Li stated: "The FIM clinical results of SIKELIA™ mark an important milestone in our mission to transition from product innovation to transforming patient care. We are highly optimistic about the potential of SIKELIA™ to improve outcomes for patients with severe aortic stenosis, and these preliminary results lay a solid foundation for subsequent clinical trials."
At the meeting, fromProfessor Zhang Xiaochun from Zhongshan Hospital, Fudan UniversityThe excellent presentation attracted the attention of many industry leaders and medical professionals. They believe that the leadership, originality, safety, and economic accessibility of SIKELIA™ are not only suitable for developing regions but also fully meet the standards of developed regions in Europe and America, demonstrating the innovative strength of China's medical device enterprises.Multiple overseas media reports consider this research achievement to be one of the most cutting-edge scientific results presented at the TCT 2024 conference.。
The ease of use, safety, originality, and economic accessibility of SIKELIA™ Polymer TAVR make it not only suitable for developing countries like China but also fully meet the needs of developed countries and regions such as the US and Europe. It will become a groundbreaking achievement for China-produced high-end medical devices to enter the ranks of international leaders. MitrAssist Lifesciences will continue to bring more beneficial disease treatment options to doctors and patients worldwide with its continuously growing passion for research and innovation. As Academician Ge Junbo said, we will maintain our exploration of life sciences and gradually approach the truth of life.
SIKELIAᵀᴹ Transfemoral Aortic Valve Replacement System uses valve leaflets made of a proprietary polymer material developed by MitrAssist Lifesciences, as opposed to traditional animal pericardial valve leaflet materials.，With the advantages of zero calcification, low coagulation, and high biocompatibility。The theoretical lifespan of the SIKELIAᵀᴹ product after implantation can reach 20-25 years, making it suitable for younger patients and significantly expanding the range of applicable patients for similar products. In terms of production technology, fully automated industrial production can be achieved, greatly reducing product costs and significantly improving the pass rate. Its stent design features a unique memory alloy wire riveting structure, does not rely on radial support force for fixation, and includes a large mesh design. Additionally, this valve has the characteristics of being pre-assembled at the factory and fully recoverable, with its 100% recoverable feature greatly ensuring patient safety during surgery.
The numerous innovative products at TCT 2024 have brought new hope for the treatment of cardiovascular diseases, and the future development is highly anticipated.
The Remaining Ten Cardiovascular Technical Events
1. Boston Scientific'sAcurate neo2 Aortic Valve SystemThe trial did not meet the study endpoint.
SIKELIA™ Research Background
A prospective clinical study explored the feasibility, safety, and effectiveness of MitrAssist Lifesciences Limited's SIKELIA™ Transcatheter Aortic Valve System in treating patients with severe aortic stenosis. The study utilized a prospective, single-arm clinical trial design, applying the SIKELIA™ Transcatheter Aortic Valve System for aortic valve replacement in symptomatic patients with severe aortic stenosis who were at high risk or contraindicated for surgical intervention. Follow-up was completed 30 days (±7 days) post-procedure. The research was conducted by a clinical trial institution certified by national qualifications as the research center, covering three centers:The team of Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University、Yunnan Fuwai Cardiovascular HospitalPan XianghuiProfessor TeamAndProfessor Wang Yan's Team from Xiamen Cardiovascular Hospital, a total of 10 subjects were enrolled, with 9 patients eventually completing the implantation and 1 patient receiving a valve-in-valve implantation. The first patient implanted with SIKELIA™ has currently survived for up to 29 months post-operation.
SIKELIAᵀᴹ Transcatheter Aortic Valve System Deployment Process
SIKELIA™ Extended Reading
MitrAssist Lifesciences, established in 2017, is a globally leading innovative platform-based medical device enterprise in the cardiovascular field. Its products cover major areas such as structural heart, heart failure, and coronary artery diseases, with a rich product pipeline. The company owns 156 authorized PCT patents globally. It is a representative enterprise of "future materials" in Shanghai's future industry. Currently, it has research and development centers in China, Israel, and Germany, an independent sales team in the United States, and a mature distributor system in multiple countries overseas.
The founding team of the group company consists of senior professionals who have深耕 (deeply engaged) in the medical industry for many years, possessing disruptive technological innovation capabilities and outstanding international perspectives. Since its establishment, MitrAssist Lifesciences has always adhered to the mission of "MitrAssist Lifesciences, guided by heart, empowered by global technology, healing hearts worldwide," with the strategic goal of achieving universal accessibility in cardiovascular healthcare. Continuously innovating and striving to achieve “excellence where others exist, and uniqueness where others do not.”
On July 6, 2022, SIKELIA™, the world's first polymer valve Polymer TAVR product independently developed by MitrAssist Lifesciences, was successfully clinically implanted globally by a team led by Academician Ge Junbo at Zhongshan Hospital, Fudan University, Shanghai. This marks the entry of interventional treatment for valvular heart disease into a new polymer era. Currently, the product has completed the FIM clinical trial, with multiple patients having postoperative follow-ups exceeding one year, and the longest postoperative follow-up reaching 21 months, demonstrating its feasibility, safety, and effectiveness. The project also won the highest award, "Outstanding Award," in the 2022 National Ministry of Science and Technology's Disruptive Technology Innovation Competition. MitrAssist Lifesciences has independently developed China’s first transapical mitral valve interventional replacement product.MitraFix® has entered the special review for innovative medical devices by the National Medical Products Administration. This product is not only safe and reliable but also easy to use, convenient for promotion, and requires only full ultrasound guidance throughout the surgery. ReDS™ Pro, a non-invasive heart failure management device from MitrAssist Lifesciences, has been approved for marketing in China after being launched in the US, Europe, India, and Japan. The ReDS device is currently the world's only non-invasive heart failure management device based on the 5A principle. "Paclitaxel Drug-Coated Coronary Balloon Dilatation Catheter" – SwiftBird® from MitrAssist Lifesciences Limited has been approved for marketing in China as the first product of its kind domestically using fourth-generation paclitaxel drug coating technology.