MicroPort® CardioFlow Completes First Clinical Application of TMVR System Under Compassionate Use in France

Lille, France, January 15, 2024 — Recently, MicroPort® CardioFlow's Transcatheter Mitral Valve Replacement System (TMVR System) completed its first clinical application under compassionate use at the Lille University Hospital Center in France. The procedure, led by Professor Thomas Modine's team, resulted in a stable recovery for the patient, with good hemodynamic improvement, and the patient was discharged after recovery. The 30-day follow-up results showed complete disappearance of mitral regurgitation, no paravalvular leak, with the valve functioning well and stable in position.

The patient, a 70-year-old woman, was admitted due to ischemic mitral valve insufficiency and prolapse of the P3 segment of the posterior mitral leaflet, leading to cardiac decompensation. Echocardiography indicated left ventricular dilation with eccentric left ventricular hypertrophy, segmental motion abnormalities, and basal/mid-basal layer arterial aneurysms. The patient had an EF of 55%, moderate tricuspid regurgitation, and right ventricular dilation. Considering the high risk of surgical intervention and unsuitability for transcatheter edge-to-edge mitral valve repair, the hospital's cardiac team decided to perform a transcatheter mitral valve replacement using MicroPort® CardioFlow’s TMVR system.

Before the procedure, Professor Thomas Modine's team and the MicroPort® CardioFlow TMVR team engaged in extensive discussions, conducting measurements and analyses based on CT imaging to assess intraoperative risks and formulate a strategy. The patient's anatomical structure of the apical puncture site was deemed ideal with a low risk of left ventricular outflow tract obstruction.

The procedure involved a minimally invasive incision at the left fifth intercostal space for apical access, placement of the delivery system under fluoroscopy, and gradual release of the valve after adjusting for circumferential alignment. The valve position was confirmed satisfactory through fluoroscopy and TEE before removing the delivery system. The entire procedure, from insertion to removal of the surgical instruments, took only 20 minutes. Postoperatively, the mitral valve showed good morphology and function, with significant improvement.

Previously, MicroPort® CardioFlow has completed several implantations of TMVR system under compassionate use. The immediate surgical outcomes, as well as follow-up results at 30 days, 6 months, and 1 year, have been outstanding. Key patient indicators have shown significant improvement compared to preoperative conditions.

About MicroPort® CardioFlow

Founded in 2015, MicroPort® CardioFlow (MicroPort® CardioFlow Medtech Corporation;HKEX: 02160) is a leading medical device company focusing on research, development and commercialization of innovative transcatheter and surgical solutions for valvular heart disease.

MicroPort® CardioFlow 's self-developed transcatheter aortic valve implantation series products have successfully landed more than 600 core hospitals worldwide. Furthermore, MicroPort® CardioFlow has established a strategic Research and Development pipeline covering transcatheter aortic valve treatment products (iterative products), left atrial appendage closure systems (iterative products), transcatheter mitral valve treatment products, transcatheter tricuspid valve treatment products, and surgical accessories through in-house development and collaboration with global partners. MicroPort® CardioFlow strives to provide total solutions for structural heart diseases, dedicated to providing high quality therapeutic solutions to patients and physicians across the globe.

More information is available at www.en.cardioflowmedtech.com.