Recently,Shanghai Shape Memory Alloy Co., Ltd. (a wholly-owned subsidiary of LEPU ScienTech Medical Technology (Shanghai) Co., Ltd.)Developed byCeniper®One-Time Room Partition Puncture System Receives Registration from China's National Medical Products Administration (NMPA)Approval (China Medical Device Registration No. 20243031466)。This product is used in cardiac catheterization procedures.Atrial Septal Puncture, to access the left heart approach, can provide more new support and options for clinical use.
(Source: Electronic Certificate Verification Center of the National Medical Products Administration)Safe and Stable · Precise and Accessible
Currently,Atrial Septal PunctureIt has become one of the most commonly used techniques in interventional cardiology and is a key step in structural heart and electrophysiology left-heart interventional treatments, utilized for treating left-heart system arrhythmias, left atrial appendage closure, and percutaneous procedures.Left Ventricular Assist DeviceImplantation and various mitral valve lesion surgeries, etc. With the continuous development and advancement of cardiac interventional technology, the demand for related surgeries continues to grow.According to Frost & Sullivan statistics, the number of cardiac electrophysiology procedures in China reached 214,000 in 2021. With the increasing degree of population aging and the continuous growth in the number of patients, the number of cardiac electrophysiology procedures in China has been experiencing steady growth. Meanwhile,Left Atrial Appendage OcclusionThe application is also gradually expanding, with about 20,000 surgeries performed in 2022, and it is expected to increase to 40,000 by 2024. In addition, from 2021 to 2023, the number of mitral valve interventional surgeries in China increased from 182 to 1,274. This surgery has demonstrated a significant supply and demand gap, and it is predicted that by 2025, the number of such surgeries will reach over 10,000, achieving rapid growth.
Based on clinical actual needs,Ceniper®The one-time atrial septal puncture system is designed to provide a controllable, safe, and stable atrial septal puncture procedure.Its needle adopts a tapered small-angle bevel design, facilitating precise and efficient puncture;Needle shoulder step structure, controllable needle tip extension length, reducing the risk of slippage;Distal dual-curve design ensures torque control and coaxiality, facilitating precise positioning.Oval fossa; The bilateral hole design at the distal end of the sheath reduces the possibility of cavitation, further enhancing operational safety; meanwhile, the sheath tube displays clear imaging, and the distal platinum ring design enables precise positioning under fluoroscopy, providingThe doctor provided great convenience.Benefits. In addition,Ceniper®Compared with the approvedRF-Lance®Radiofrequency Atrial Septal Puncture SystemJointly form a series of product matrices,With their respective unique technical advantages,Will provide more safe and effective options for clinical use, meeting the treatment needs of different patients.
Continuous Innovation · High-Quality Development
This time, the successful approval of the Ceniper® disposable atrial septal puncture system has further enriched LEPU ScienTech Medical's product portfolio in the cardiac interventional access pipeline, laying a solid foundation for the company’s continuous development and innovation in this field. In the future, LEPU ScienTech Medical will steadfastly follow the path of innovation-driven development. While deeply cultivating the field of structural heart disease, it will also explore broader medical application scenarios, using "innovation" to enhance "quality." The company aims to build an open and compatible high-quality medical device ecosystem, unleash greater potential in clinical services, and make innovative medical resources more accessible!
ScienTech MedicalScienTech Medical is a high-tech enterprise focusing on the research, development, production, and operation of interventional medical devices for structural heart disease. After more than 20 years of dedication, the company has become one of the largest manufacturers in China of occlusion devices for structural heart disease and related surgical配套 products, with a comprehensive product line layout in the field of structural heart disease. It is also an industry leader in being among the first to apply bioresorbable technology to the field of structural heart disease. In the future, ScienTech Medical will continue to focus on innovative R&D, strengthen the construction of its core technology platform and independent intellectual property rights management system, promote the expanded application of innovative technologies, and drive the transformation of new productive forces. This will bring higher-quality products and more advanced and complete medical solutions to patients in China and around the world.
LEPU MedicalAs the controlling shareholder of ScienTech Medical, it is one of the early enterprises in China engaged in the research, development, and manufacturing of cardiac interventional medical devices. Guided by the current development strategy of "cardiovascular medical devices + cardiovascular medicines + medical services and health management integration," the company is committed to meeting the growing comprehensive needs of the Chinese population for cardiovascular health, elderly care, and rehabilitation. The company has undertaken several national key scientific research projects and has been awarded the "National Engineering Research Center for Cardiovascular Implantable and Interventional Devices and Equipment" by the Ministry of Science and Technology of China. The company’s self-developed bioresorbable stents, drug-coated balloons, cutting balloons, and degradable...Occluder、TAVR valve, artificial intelligence ECG automatic analysis and diagnosis system and other products, with technology reaching the industry's advanced level.
