Lepu Scientech Subsidiary's New RF-Lance® Radiofrequency Transseptal Puncture Generator Receives NMPA Approval

Source: Lingang Songjiang Science Park, Heart Technology Medical

Recently, RF-Lance® Radiofrequency Puncture Generator, independently developed by Shanghai Shape Memory Alloy Co., Ltd. (a wholly-owned subsidiary of MicroPort CardioFlow Medtech Corporation under Lepu Medical Technology (Shanghai) Co., Ltd.), received registration approval from the National Medical Products Administration (NMPA) (Registration Certificate No.: 20243010854).

As the first domestically-produced RF puncture generator system to receive NMPA approval in China, the successful development and market launch of RF-Lance® represents another milestone achievement for MicroPort CardioFlow Medtech Corporation in the fields of cardiac electrophysiology and structural heart disease. This breakthrough will offer doctors and patients a new range of safer, more efficient, and precise medical solutions.

▲Source: Official website of the National Medical Products Administration

With the continuous advancement of interventional therapy in 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 surgery, where establishing left heart access is crucial. Transseptal puncture (TSP), as a key technique, is closely linked to the markets for cardiac electrophysiology, left atrial appendage closure, and mitral valve interventions.

According to statistics, the number of cardiac electrophysiology procedures in China reached 214,000 cases in 2021, with a compound annual growth rate (CAGR) 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 been growing steadily. It is expected that by 2024, the number of cardiac electrophysiology procedures in China will reach 489,000 cases, with a CAGR of 23.3%; By 2025, the number of cardiac electrophysiology procedures in China is projected to reach 574,600 cases, with a CAGR as high as 28.00%. With the gradual promotion and application of emerging ablation technologies in clinical practice, the number of cardiac electrophysiology procedures in China will further increase, and it is expected to reach 1,629,500 cases by 2032, with a CAGR of 16.06% from 2025 to 2032. (Source: Frost & Sullivan's "Research Report on China's Cardiac Electrophysiology Device Market", Zhongjin Qixin International Consulting's "In-depth Analysis and Investment Strategy Feasibility Assessment and Forecast Report on the Entire Industrial Structure of the Cardiac Electrophysiology Device Industry from 2024-2029")

At the same time, the application of left atrial appendage closure is 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, showing a significant supply and demand gap. It is predicted that by 2025, the number of such surgeries will exceed 10,000, achieving rapid growth. (Source: Frost & Sullivan, "2023 Annual Report on Structural Heart Disease")

Overall, the annual demand for atrial septal puncture procedures has exceeded 200,000 cases. With the increase in atrial fibrillation patients and the aging trend, the atrial septal puncture technology will embrace a larger market space, indicating broad prospects.

However, traditional mechanical puncture technology, due to its 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 standards of modern clinical practice. Based on this, the new RF-Lance® Radiofrequency Puncture Generator has emerged.

▲RF-Lance® Radiofrequency Puncture Generator

The accompanying RF puncture needle is currently under review by the National Medical Products Administration (NMPA).

The significant advantage of this innovative instrument lies in its use of blunt electrodes to deliver brief and highly focused radiofrequency energy pulses, employing radiofrequency energy at the predetermined atrial septal puncture site to complete the atrial septal puncture procedure. This not only increases the success rate of the puncture, shortens operation time, but also allows for more precise confirmation of the tip location, avoiding unnecessary tissue damage. Additionally, the instrument is easy to operate, equipped with an LCD touch screen, automatic system parameter storage, one-touch start for convenience and speed; foot pedal synchronized radiofrequency ensures stable energy emission.

The successful launch of the RF-Lance® Radiofrequency Puncture Generator not only enriches the product portfolio of MicroPort CardioFlow Medtech Corporation in the field of cardiac electrophysiology, but also provides a safer and more efficient tool for current clinical atrial septal puncture procedures, with broad application prospects in the future.

Continuous Innovation, Moving Forward Together! Shanghai Shape Memory Alloy Co., Ltd. will continue to adhere to the principle of innovation-driven and quality-first, further increase R&D investment, develop more innovative and high-quality medical products, serve clinical needs, benefit patients, and make greater contributions to the cause of human health.