Dalian, China - On December 18, 2019, Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP") used its independently developed contact force-sensing RF ablation catheter ('contact force-sensing catheter") to complete an atrial fibrillation ablation procedure under the guidance of Columbus® 3D EP Navigation System ("Columbus®") at the First Affiliated Hospital of Dalian Medical University. It indicated the official launch of a prospective, multi-center clinical trial in China to evaluate the safety and efficacy of the contact force-sensing catheter.
The principal investigator of the clinical trial is Professor Lianjun Gao from the First Affiliated Hospital of Dalian Medical University, who is joined by Professor Shaowen Liu from Shanghai General Hospital, Professor Bing Yang from East Hospital in Shanghai and Professor Huimin Chu from Ningbo First Hospital. The first case was performed by a clinical team led by Professor Lianjun Gao to complete atrial fibrillation ablation procedure under the guidance of Columbus®.
Under the direction of Professor Lianjun Gao, Professor Rongfeng Zhang used the contact force-sensing catheter to complete pulmonary vein isolation procedure for atrial fibrillation smoothly, with the patient in stable condition after the operation. Professor Lianjun Gao commented on MicroPort® EP's contact force-sensing catheter, "The contact force-sensing catheter can provide positioning information and real-time measurement of contact force between catheter tip and endocardium. The access to real-time contact force between catheter and endocardium can allow doctors to ablate target tissues with appropriate force. The contact force-sensing catheter has demonstrated first-rate performance in terms of operational experience and effects. It will bring more options to Chinese doctors and patients."
Cardiac radiofrequency ablation is an interventional treatment for tachyarrhythmia. In this therapy, a very thin catheter is put into the blood vessels from the neck or femoral vein and radio frequency currents are released to eliminate the cause of the disease once for all after the catheter reaches the lesion. The therapy has now become the preferred method to cure tachyarrhythmia. The radiofrequency catheter used in the therapy has evolved from the earliest catheter to 3D catheter, irrigated catheter and the latest contact force-sensing catheter. Compared to conventional 3D catheter, the contact force-sensing catheter has a shorter learning curve for doctors, cuts durations of the procedure and X-ray exposure, and reduces the incidence rate of complexities. As a result, the safety and success rate of the procedure have been greatly improved.
Currently, the internationally mainstream contact force-sensing catheter can only be supplied by two foreign producers. The contact force-sensing catheter used in the first enrollment is independently designed and developed by MicroPort® EP and is expected to become the first Chinese-made such device to be approved to launch in China. The device closely meets the clinical needs, as the adopted method to measure contact force can display the force in real time to guarantee the ablation during atrial fibrillation ablation procedure, which not only increases the safety and effectiveness of the procedure but also significantly improves the operating experience of physicians.
The contact force-sensing catheter of MicroPort® EP was granted entry into the Special Review and Approval Process for Innovative Medical Devices with the National Medical Products Administration of China (NMPA) on October 20, 2017. The successful completion of the first case in the clinical trial for the device will expedite its market launch in China with the expectation to benefit more patients. MicroPort® EP President Dr. Yiyong Sun said, "It is believed that in the near future, the NMPA approval and launch of the Chinese-made contact force-sensing catheter will greatly reduce the national medical expenditure and patients' economic burdens, while promoting international cutting-edge technologies in clinical practice and propelling the development of relevant domestic sectors. MicroPort® EP will also continuously explore to innovate to provide Chinese and even global patients and doctors with accessible integrated therapeutic solutions in the field of cardiac electrophysiology."