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Structural Heart Technologies New ISO 22679

Free Interactive Webinar – Meet The Experts

August 5th, 2020

The structural heart occluders market is expanding rapidly and a new wave of technologies are being developed to enhance the transcateter treatment of congenital or iatrogenic disorders such as atrial and ventricular septal defects, patent foramen ovale, left atrial appendage closure and paravalvular leak. Given the lack of commonly accepted methodologies to establish safety and performance of cardiac occluders, there is and urgent need for guidance in this sector.

This new, exclusive webinar, will present for the first time an outline of the new ISO 22679 draf standard for transcateter cardiac occluders, that can be used to produce a risk based strategy for accelerating the development, validation, and approval of occluders in the global market. In-depth guidance is provided for all steps of the product lifecycle, from design to preclinical validation and clinical trials. You will learn the step-by-step tools needed to conduct and complete the required product assessments , as well as the recommended in-vitro animal evaluations,alternative implantation techniques, pathways to clinical trial development, and more. The skills gained during the webinar will help guide you forward in applying the new standard that establishes effective safety and performance of cardiac occluders.

WEBINAR TOPICS

Learning and following this standard, developers can perform complete and correct assessment of the product’s physical, mechanical, chemical, and biological properties of transcatheter cardiac occluders and of their materials and components. Recommended in-vivo animal evaluations are also provided, including choice of animal model; study duration; device size; sample size; applicability and relevance based on similarities or differences between animal model and humans for devise use; and also, alternative implantation site or techniques.

Extensive guidelines are provided to design and conduct clinical trials, including imaging assessment, target population and follow-up duration and methods, as well as objective criteria for establishing safety, usability and clinical benefits.

The speakers are all expert members of the International Standardization Organization (ISO) Technical Committee 150, Subcommittee 2, Cardiovascular implants and extracorporeal systems.

Presenters:

  • Bobak Mosadegh, PhD, Assistant Professor of Biomedical Engineering in Radiology, Weill Cornell Medicine
  • Monica Tocchi, MD, PhD, Medical Director Meditrial, Cardiologist & Regulatory Expert
  • Simon Dunham, PhD, Assistant Professor of Electrical Engineering in Radiology, Weill Cornell Medicine

CONTACT US
intouch@meditrial.net
T: +49 30 91 45 70 06
F: +49 30 91 45 73 70

Expert Biographies

 

Dr. Monica Tocchi is a medical doctor and cardiologist, with a postdoctoral degree in Cardiovascular Pathophysiology from the University of Rome, Italy. She has co-authored breakthrough studies on endovascular procedures, coronary stents, atrial fibrillation ablation, and point of care testing for risk prediction in cardiovascular disease. She is founder and CMO of Meditrial, and international consulting company. She has been served as regulation experts in the International Standardization Organization (ISO) for more than 20 years. She is an expert contributor in the following standards: ISO 14155for medical device clinical trials: ISO 5840 (Parts 1-3 for surgical and transcatheter cardiac valve replacement;, ISO 5910 for cardiac valve repair; and and ISO 22679 for transcatheter cardiac occluders.

Dr. Mosadegh received his Ph.D. from the University of Michigan in Biomedical Engineering and did his postdoctoral training at Harvard University. He is currently an Assistant Professor in the department of Radiology at Weill Cornell Medicine, where he is a member of the Dalio Institute of Cardiovascular Imaging. His research focuses on the development of cardiovascular devices and guidance systems. He has over 60 publications, a h-index of 34, and over 10 issued patents. Dr. Mosadegh serves as convener for the ISO/TC 150/SC 2/WG 8, which is developing the first international standard on transcatheter cardiac occluders, ISO 22679.

Dr. Dunham obtained his PhD from University of Illinois, Champaign-Urbana.  Since joining the faculty of the Dalio Institute at Weill Cornell Medicine his research aims to find new ways to utilize soft materials, 3D printing, micro/nanotechnology, and flexible electronics for the fabrication of diagnostics and therapeutic devices. His lab has developed a variety of novel devices, including transcatheter occluders, sensor arrays, and benchtop simulators.  He has also developed a wide variety of methods to support the development of these technologies including scalable approaches for applying bioinspired micropatterns to surfaces and developing flexible sensors arrays from commercially available components.  He currently serves as a member of the ISO committee on cardiac occluders and a co-chair to the AAMI committee.

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