3D EP Navigation System Project

Reshaping Health Professional Training 3D EP Navigation System Project

Purpose

Conclude the 863 Project and finally achieve commercialization.

Background

Atrial fibrillation is one of the most common persistent arrhythmias in clinical practice. It is a common cardiovascular disease just after hypertension and coronary heart disease in China. There are nearly 10 million patients with atrial fibrillation in China.

In recent years, the technique of transcatheter ablation for the treatment of atrial fibrillation has developed rapidly. Before the 3D mapping system was used in clinical practice, catheter ablation for the treatment of atrial fibrillation was performed under the guidance of 2D image fluoroscopy. As this method cannot clearly display the 3D anatomy of the heart chamber, it is difficult to select the ablation target accurately. The rate of radical cure is only about 50%. The ablation catheters used for atrial fibrillation ablation were imported from abroad at that time, which were expensive and severely restricted the extensive application of atrial fibrillation catheter ablation technology in China. Although there were conventional diagnostic and ablation catheters under development at that time, catheters used for 3D mapping and localization in the treatment of atrial fibrillation have not entered the development stage yet. Therefore, in 2014, MicorPort® collaborated with a top-tier hospital in Beijing to conduct research on related topics, aiming to develop the 3D EP Navigation System, and conduct research and development on the compatible diagnostic and ablation catheter.

By reconstructing the 3D anatomic geometry of atrial, the 3D navigation system can clearly display the key structure, and physicians can preciously select the ablation target by using its navigation function. With the help of 3D navigation system, the radical rate of atrial fibrillation can be increased to 80-90%. At present, catheter ablation guided by 3D navigation system has become one of the most effective treatments for atrial fibrillation. Therefore, 3D navigation system has become an indispensable tool for the treatment of atrial fibrillation. The 3D EP Navigation System is the first mapping system based on magnetic positioning technology developed in China. Following the clinical trials and post-market clinical data collection, the system is well received with its steady performance and good mapping accuracy.

History

  • In 2007, the 3D EP Navigation System Project was officially launched;
  • In December 2010, the 3D EP Navigation System Project entered the clinical trial stage;
  • In 2015, the 3D EP Navigation System entered the Special Review and Approval Procedure for Innovative Medical Devices, or the “Green Path”;
  • In March 2016, the 3D EP Navigation System obtained the CFDA registration certificate;
  • In December 2017, the 3D EP Navigation System Project is listed in the Science and Technology Innovation Action Plan organized by the Shanghai Science and Technology Commission, the project of the cooperation between the industry, universities, research institutes, and medical community, as well as the Research on the Exemplary Clinical Application and Re-evaluation of Innovative Electrophysiological Products.

Achievements

  1. Successfully concluded scientific research cooperation and achieved the conclusion of the project;
  2. A total of six patents were granted and five papers were published;
  3. The commercialization has been completed. From July 2016 to March 2019, the number of cases has reached more than 4,500, covering supraventricular tachycardia, premature ventricualr contraction, atrial fibrillation, and atrial tachycardia
  4. The product has been used in more than 300 centers in China and entered the international market.