WPS Presentation

Myval China. A prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the Myval transcatheter heart valve system in patients with symptomatic severe aortic stenosis..

[Audio] Myval's Transcatheter Heart Valve System has a revolutionary new design concept the Hybrid Honeycomb Cell Design. On the upper half it features open cells to prevent blocking of coronary ostia and on the lower half closed cells for enhanced radial strength. It also has a unique external P-E-T buffing to minimize para-valvular leaks a bovine pericardium tri-leaflet valve an internal P-E-T sealing cuff for lower profile and puncture resistance and a Nickel Cobalt alloy frame for high radial strength and Radial Occlusion of approximately 53%. It comes in four sizes – 20 millimeters 23 millimeters 26 millimeters and 29 millimeters – and is adjustable to 21.5 millimeters 24.5 millimeters 27.5 millimeters 30.5 millimeters and 32 millimeters (X-L---). The frame height ranges from 17-20 millimeters and has been developed by Meril Life Sciences in Vapi India receiving approval in India in October 2018 and CE Marked in April 2019. Globally Myval’s Transcatheter Heart Valve System has been implanted more than 3000 times with excellent results..

[Audio] We at Myval China are proud of the cooperation we have had with 15 Clinical Trial Institutions and the successful recruitment of 128 formal trial Subjects 158 Subjects and 30 Learning Curve Cases. The initiation of the clinical study was on April 11th 2024 at our lead site The Second Affiliated Hospital of Zhejiang University School of Medicine. We are dedicated to ensuring the safety and efficacy of our Myval transcatheter heart valve system for patients with symptomatic severe aortic stenosis. This clinical study is only the beginning of our journey..

Patient Process Flow.

[Audio] Participants of the clinical study conducted by Myval China must have symptomatic severe aortic stenosis and must be evaluated by the cardiac team as not suitable for conventional surgery and suitable for treatment with the Myval Transcatheter Heart Valve System. After meeting the eligibility criteria participants will take part in Stage I a 30-day confirmation/screening interval followed by enrollment in Stage II and a 6-month follow up. Collected data will be used to assess the safety and efficacy of the Myval transcatheter heart valve system in this patient population..

[Audio] Myval China is committed to employee engagement and the Human Resources department. To demonstrate this we are conducting a prospective multicenter single-group target value clinical study to evaluate the safety and efficacy of our Myval transcatheter heart valve system. The study involves assessing eligibility criteria and then carrying out a confirmation or screening process and an implantation procedure. All of these steps ensure the safety of those eligible. Additionally a 30-day follow up care unit has been established to address any potential issues that may arise..

[Audio] Subjects aged 65 and above suffering from symptomatic severe aortic valve stenosis with a New York Heart Association cardiac functional class of at least II and assessed by the cardiac team as not suitable for routine surgery may participate in the Myval transcatheter heart valve system clinical study if they or their legal representative sign a written informed consent form and can undergo follow-up visits. Excluded from the study are female subjects who are pregnant or lactating individuals with a known allergy to implant material components contraindications or allergies to antiplatelet and/or anticoagulant therapy preoperative echocardiography showing intracardiac masses a history of gastrointestinal bleeding or coagulation disease within the last three months acute myocardial infarction or diagnosed stroke within the last 30 days before surgery..

[Audio] Individuals who have undergone any invasive therapeutic cardiac surgery within the last 30 days active infective endocarditis within the last 30 days and previous aortic valve graft implantation are excluded from participation in the study. In addition those with severe coronary artery stenosis requiring revascularization severe renal insufficiency severe aortic tricuspid or mitral regurgitation any other condition which the investigator or heart team believes may prevent the subject from safely participating in the study and those who are participating or planning to participate in other drug or device clinical trials within 12 months after surgery are also excluded..

[Audio] The slide displays a table comprising of events demographic details medical background physical examination N-Y-H-A classification mRS score inclusion criteria analysis K-C-C-Q score concomitant drugs AEs/SAEs lab measurements such as blood routine blood biochemistry coagulation capability cardiac markers myocardial markers pregnancy test 12-lead E-C-G transthoracic or transesophageal echocardiography cardiac/great vessel/peripheral vascular computed tomography angiography D-S-A contrast valve implantation and instrument defects..

[Audio] We at Meril Life Sciences recognize that clinical research is fundamental for medical advancement. Our Clinical Consultancy Research Center (R-O-C-K-) is formed by a team of specialists who have extensive expertise and are dedicated to helping our clients assess the safety and efficacy of their medical devices. Partnering with Myval China we are sure that we can deliver the best outcomes for their clinical investigation..

[Audio] Myval China has invested in the clinical trial of its Myval transcatheter heart valve system by paying multiple partners associated with its research and development. The accompanying table shows the invoices payment details and payment status of each payment received by Myval China. This research will help Myval China achieve its mission of providing patient care solutions and ensuring a successful clinical trial..

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