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Ningbo,China—Subjectenrollment forthepre-market multi-center clinical trial of the Contact Force-SensingRFAblation Catheter (the “Contact Force-Sensing Catheter”) developed byShanghai MicroPortEP MedTech Co., Ltd. ("MicroPort EP"), completedon March 30, 2021 as the final operationunder the trial wasperformed by HuiminChu’s team in the Department of Cardiovascular Medicine atNingbo FirstHospital, using the Contact Force-Sensing Catheter in combinationwiththeColumbus™ 3D EP Navigation System (“Columbus™”).
The clinical trial of the ContactForce-Sensing Catheter is a prospective, multi-centerclinical study designed toevalsuate the safety and efficacy of the pressuremonitoring function of the catheter,the tubing set, and the 3D EP navigationsystem developed and manufactured byMicroPort EP foratrial fibrillation clinical applications. The study wasled bythe First Hospital of Dalian Medical University, with collaborator from oftheFirst Hospital of Ningbo, the First People’sHospital of Shanghai, ShanghaiOriental Hospital,and Xuzhou Central Hospital.
Atrial fibrillation (AF) isone of the mostcommon cardiac arrhythmias with high incidence and wideprevalsence and may causecomplications such as stroke and heart failure, which couldimpose a greatfinancial burden on affected families and society. Currently,althoughradiofrequency (RF) ablation has become an effective treatment for AFdue toits low invasiveness and fast recovery, the energy generated by RFablation haslittle selectivity in destroying tissues in the ablation area andthe proceduredepends on the contact force of the catheter. Therefore, inclinical practice,there is an urgent need for a product that providesintraoperative informationon catheter contact orientation and contact forcelevel, which facilitates the transmuralablation of lesionsin a safer, moreeffective and continuous way to create sustained electricalisolation thatimproves the success rate of procedures.
The Contact Force-Sensing Catheter used inthisclinical trial provides the surgeon with real-time force values of thecatheterwhere it comes in contact with the inner wall of the cardiac cavityduring AFablation procedures. Compared with conventional 3D catheters, it can shortenproceduretime and reduce complications and X-ray damage to both the patientand thesurgeon. The Contact Force-Sensing Catheter also helps to shorten thelearningcurve for newly trained surgeons. Currently, this catheter has passedthespecial approval process of the NMPA for innovative medical devices and isexpected to become thefirst domestic contact force-sensing catheter to becertified for marketing inChina.
Chu Huimin, Director of theFirst Hospitalof Ningbo, highly appreciated the cooperation with MicroPort EP,saying,“Although the EP industry in China started late, we are confident thatMicroPort EP is capable of developing and improving the portfolio ofmade-in-China EPproducts while leading China’s EP industry to thrive in its ownpath.”
Dr. Yiyong Sun, Presidentof MicroPort EP,said, “We were facing difficult challenges during the implementationof thisclinical trial due to the impact of the COVID-19 pandemic. Therefore, wearevery grateful for the strong support from hospitals involved in this study.Thecompletion of subject enrollment is an important milestone in theclinicaltrial, and we look forward to receiving early results that arehopefully inline with our expectations. In the future, MicroPort® EP willinvest moreresources in innovative research and development, as well asclinical trials,to provide better integrated solutions for patients anddoctors.”
