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Up to October 2023, Columbus™ 3D EP Navigation System (referred to as Columbus™ 3D System) developed by Shanghai MicroPort EP MedTech Co., Ltd. (referred to as MicroPort EP) has performed more than 50,000 arrhythmia treatment procedures.
Cardiac radiofrequency ablation is an interventional technology that releases radiofrequency current to kill abnormal myocardial cells at specific sites to block abnormal conduction bundles and origins of tachyarrhythmia. With the technological progress and widespread application of 3D mapping equipment and consumables, 3D catheter ablation procedure has gradually replaced 2D catheter ablation procedure and become the mainstream treatment. The advanced 3D EP navigation system can display the structure of the heart and vessels by establishing a 3D cardiac model on computer, combining the IECG with the 3D spatial structure of the heart, thereby guide physicians in catheter operation and positioning, improve safety and efficacy of ablation and reduce the amount of radiation.
As a pioneer in 3D electrophysiological procedures in China, MicroPort EP has been targeting the technical bottleneck of 3D procedure since its establishment and has continuously made breakthroughs. In 2015, the first-generation Columbus™ 3D system independently developed by the company entered the special approval process for innovative medical devices, it was the only domestic 3D cardiac electrophysiological mapping system to enter the green channel at that time. With the first-generation Columbus™ 3D system got NMPA in 2016, MicroPort EP has accelerated the technological innovations. In 2020, the third-generation Columbus™ 3D system, which is the first domestic magnetic and impedance based 3D mapping system, was approved by the National Medical Products Administration (NMPA), which marked another major breakthrough. Currently, the upgraded fourth-generation Columbus™ 3D system will also obtain the NMPA certificate by the end of 2023.
The increase in the number of surgeries is the best compliment for an innovative medical device. It took MicroPort EP almost 9 years from the first pre-market clinical case of the Columbus™ 3D system in December 2011 to exceed 10,000 procedures in May 2020. However, since then, the breakthrough from 10,000 to 50,000 cases only took less than three and a half years, promoting MicroPort EP to achieve an important milestone in the average annual number of cardiac electrophysiology 3D procedures exceeded 10,000 in the past three years.
The cumulative number of 3D procedures exceeded 50,000 marks that MicroPort EP, together with physicians from all over the world, has provided high-quality diagnosis and treatment services to increasing patients. In this process, the clinical demands have also led to the launch of more innovative technologies and products such as FireMagic™ TrueForce™ ablation catheter.
Radiofrequency ablation treatment utilizes force-sensing ablation catheter to facilitate diagnosis and treatment of patients with atrial fibrillation. The integration of FireMagic™ TrueForce™ ablation catheter and Columbus™ 3D system has improved the safety and efficacy of ablation treatment by incorporating Force (F)、Power (P) and Time (T) in a weighted formula, generating EI index which can be utilized to estimate lesion depth in real-time. Moreover, when the latest version of Columbus™ 3D System V3 with Smart Label Module integrated with real-time distance measurement of catheter tip, it could automatically generate Smart Label, lowering the occurrence of GAP.
The company's independently developed FireMagic™ TrueForce™ ablation catheter received NMPA in 2022. It is the first domestically developed and manufactured force-sensing ablation catheter. Since the launch of FireMagic™ TrueForce™ ablation catheter in February 2023, more than 700 ablation procedures have been completed. The pre-market clinical study results were also published for the first time in Pacing and Clinical Electrophysiology (PACE). Recently, FireMagic™ TrueForce™ ablation catheter just performed its first overseas clinical case.
The breakthrough of 50,000 procedures is both a new achievement and a new starting point. In the future, MicroPort EP will continue to make innovations and develop the comprehensive solutions for diagnosis and ablation treatment centering the precise interventional navigation, providing safer and more effective treatments for patients with tachyarrhythmia around the world.
