Source: Shape Memory Alloy; Editor: Bai Xiaofei
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently, byShanghai Shape Memory Alloy Co., Ltd.(Developed independently by a wholly-owned subsidiary of LEPU ScienTech Medical Technology (Shanghai) Co., Ltd.)RF-Lance® Radiofrequency Puncture GeneratorApproved for registration by the National Medical Products Administration(National Medical Device Registration Approval No. 20243010854).AsThe First Radiofrequency Puncture Generator System in China to Receive NMPA Approval, the successful development and market launch of RF-Lance®,YesAnother milestone achievement by LEPU ScienTech Medical in the fields of cardiac electrophysiology and structural heart disease., which will bring more safe, efficient, and precise medical solutions to doctors and patients.
▲Source: National Medical Products Administration
# Atrial Septal Puncture Market Size
Transseptal Puncture (TSP)One of the most commonly used techniques for left atrial interventional treatment.Indications include catheter ablation for atrial fibrillation, percutaneous left atrial appendage closure, various mitral valve lesion surgeries, interventional treatment for congenital heart disease, percutaneous left ventricular assist device implantation, and potential treatments requiring trans-septal access, among other procedures.All require the establishment of a transseptal puncture from right to left via femoral venous access to create the treatment pathway.。In recent years, with the rapid development of catheter ablation for atrial fibrillation, the requirements for TSP technology have reached a new height.It not only requires the operator to be able to puncture through the atrial septum, but also to puncture at the optimal site., improving the safety and effectiveness of the surgery.During the implementation of existing atrial septal puncture procedures, if the doctor lacks sufficient experience and is unable to effectively judge the distance between the tip of the puncture needle and the atrial septum, it can easily lead to iatrogenic injury and even endanger the patient's life.
Compared with the current mechanical puncture，The advantage of the radiofrequency transseptal needle lies in not solely relying on mechanical thrust, but rather assisting physicians in crossing the septal area through radiofrequency energy., reducing iatrogenic injuries caused by difficulties in septal penetration due to elasticity, tumor presence, and fibrosis levels in patients.Significantly reduce the risk of excessive breakthrough and accidental penetration of the posterior wall of the left atrium.。Due to the continuous advancements in interventional therapy within the field of cardiac diseases, the importance of left heart access has become increasingly prominent, especially in atrial fibrillation ablation, left atrial appendage closure, and mitral valve surgeries, where establishing left heart access is crucial.Transseptal Puncture (TSP), as a key technology, is closely linked to the cardiac electrophysiology, left atrial appendage closure, and mitral valve intervention markets.。According to statistics, the number of cardiac electrophysiology procedures in China reached 214,000 cases in 2021, with a compound annual growth rate of 11.60% from 2017 to 2021. With the increasing degree of population aging and the continuous rise in the number of patients, the volume of cardiac electrophysiology procedures in China has continued to grow.It is estimated that by 2024, the number of cardiac electrophysiology procedures in China will reach 489,000 cases, with an annual compound growth rate of 23.3%.；By 2025, the number of cardiac electrophysiology procedures in China is expected to reach 574,600 cases, with a compound annual growth rate (CAGR) as high as 28.00%.。With the gradual promotion and application of emerging ablation technologies in clinical practice, the volume of cardiac electrophysiology procedures in China is expected to further increase.It is expected to reach 1.6295 million cases by 2032., with a compound annual growth rate of 16.06% from 2025 to 2032. At the same time,The application of left atrial appendage closure is also gradually expanding, with approximately 20,000 surgeries performed in 2022, and it is expected to reachWill increase to 40,000 cases by 2024. In addition, from 2021 to 2023,The number of mitral valve interventional surgeries in China increased from 182 to 1,274., and this surgery has shown a huge supply-demand gap. It is predicted that,By 2025, the number of surgeries will reach over 10,000 cases., achieving rapid growth.Overall,The annual demand for atrial septal puncture has now exceeded 200,000 procedures.，As the number of patients with atrial fibrillation increases and the aging trend continues, the atrial septal puncture technology will embrace a larger market space, with broad prospects.The highest declared price for adjustable bending atrial septal puncture sheaths currently on the market is around 9500 yuan.If ScienTech Medical's radiofrequency atrial septal puncture needle is estimated at a terminal price of 10,000 yuan after its market launch, a conservative estimate,The Market Potential for RF Transseptal Puncture Needles to Reach Several Billion。
# RF-Lance® RF Puncture Generator
Traditional mechanical puncture techniques, due to their high learning difficulty, inaccurate puncture point prediction, time-consuming intraoperative puncture, and the potential to cause severe complications such as cardiac tamponade and heart rupture, can no longer meet the high-standard demands of modern clinical practice.Based on this, the new RF-Lance® Radiofrequency Puncture Generator was developed.
▲Source: Company official websiteThe significant advantage of this innovative instrument lies inUsing a blunt-tip electrode to deliver brief and highly focused pulses of radiofrequency energy, at the predetermined atrial septal puncture siteUsing radiofrequency energy to perform atrial septal puncture, which can not only improve the success rate of puncture and shorten the operation time, but also confirm the tip position more accurately.Avoid unnecessary damage to the tissue。
In addition, theThe instrument is easy to operate., equipped with an LCD touch screen, automatically saves system parameters,One-touch Start, convenient and fast;Foot Pedal Synchronized RF, ensuring the stable emission of energy.
The successful launch of the RF-Lance® Radiofrequency Puncture Generator not only enriches LEPU ScienTech Medical's product portfolio in the cardiac electrophysiology field but also...Provides a safer and more efficient powerful tool for current clinical atrial septal puncture procedures., with broad application prospects in the future. In addition,The accompanying RF puncture needle is also under review by the National Medical Products Administration.。
# First Enrolled Case
The Radiofrequency Atrial Septal Puncture SystemFirst Patient Enrolled in Registrational Clinical StudyByHefei High-tech Cardiovascular HospitalCompleted by Director Zhou Qing's team.The patient is a 45-year-old male with a past medical history of chronic heart failure and tachycardia-induced cardiomyopathy (echocardiography showed EF 20%). He visited Hefei High Heart Hospital. Examination results revealed atrial fibrillation, absolutely irregular heart rhythm on auscultation, and transesophageal echocardiography indicated a left atrium measuring 44mm.Indications for radiofrequency ablation exist.After comprehensive evaluation by Director Zhou Qing's team, the patient met the enrollment criteria, and it was decided to proceed with radiofrequency ablation.Under the guidance of DSA, the Swartz sheath was advanced along the guidewire to the superior vena cava, and then the guidewire was withdrawn.Insert the radiofrequency puncture needle developed by ScienTech Medical, the puncture point is located using the same method as the standard atrial septal puncture technique, and confirmed by DSA and surface ultrasound.Release RF energy to complete tissue puncture。The patient underwent catheter radiofrequency electrophysiology surgery with the assistance of 3D mapping, during which two catheters were inserted through the fossa ovalis. Therefore, radiofrequency puncture needles were used to puncture two different points on the fossa ovalis successively.Both punctures were successful at the first attempt, and the subsequent electrophysiological surgery was also completed smoothly.。▲Contrast After the Second PuncturePostoperative Evaluation:Postoperatively, Director Zhou Qing stated that using traditional mechanical puncture to address conditions such as atrial septal bulging/thickening presents certain challenges, with a low success rate of puncture and the potential to cause severe complications (cardiac tamponade).Novel RF Transseptal Puncture System Retains Traditional Transseptal Puncture Operation Habits、Short learning curve, for operators, it will enhance confidence in dealing with complex atrial septal structures. Radiofrequency puncture can lead to a higher success rate and more precise positioning; for patients, it ensures greater safety during the procedure.In this surgical procedure, the two puncture points were accurately punctured and penetrated more quickly, with good instrument handling experience.。
ScienTech Medical (02291.HK) was established in 1994, dedicated to providing safe, effective, and innovative medical solutions, is in ChinaStructural Heart Disease Interventional Medical DevicesThe Pioneer of the Industry andCongenital Heart Disease Occlusion DeviceOne of the larger suppliers in China.
CompanyFocus on the research, development, production, and marketing of interventional devices for structural heart disease.. Currently, there are 50 marketed and pipeline products, covering product lines such as the congenital heart defect occluder series for interventional treatment of congenital heart disease, the left atrial appendage occluder and patent foramen ovale occluder series for prevention and treatment of cardiogenic stroke, and the bio-interventional valve series for treating valvular stenosis and insufficiency, providing comprehensive solutions for structural heart disease intervention. These products have been sold overseas to 44 countries and regions across Asia, Europe, the Americas, and Africa.
The company has strong research and development capabilities and owns multiple innovative products with independent intellectual property rights.Pioneering the Development of Biodegradable TechnologyAs of April 26, 2023, the company owns 234 registered intellectual properties.
LEPU Medical as the controlling shareholder of ScienTech Medical, one of the early enterprises in China engaged in the research, development, and manufacturing of interventional cardiology medical devices, in the current "cardiovascular medical device+Cardiovascular drugs + Integrated medical services and health management" development strategy guidance, committed to meeting the growing cardiovascular health, elderly care, and rehabilitation needs of the Chinese population.The company undertakes several major national scientific research projects and has been awarded the "National Engineering Research Center for Cardiovascular Implantable Devices and Equipment" by the Ministry of Science and Technology. The company's independently developed products, such as bioresorbable scaffolds, drug-coated balloons, cutting balloons, degradable occluders, TAVR valves, and AI-based automatic ECG analysis and diagnosis systems, have reached advanced levels in the industry.
