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How the 30-year-old standard for implantable heart valves is trying to keep up with technological advances

This article was originally published in SRA

Executive Summary

Sarah Zanon discusses how the international standard on implantable heart valves has evolved in tandem with the growth in transcatheter-based implantation technologies, and highlights how the latest editions of ISO 5840 will impact manufacturers’ product verification and validation processes.

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How the 30-year-old standard for implantable heart valves is keeping up with technological advances

Sarah Zanon of Premier Research discusses how the international standard relating to implantable heart valves has evolved in tandem with the growth in transcatheter-based implantation technologies, and highlights how the latest editions of ISO 5840 will impact manufacturers’ product verification and validation processes

New frontiers in transcatheter heart valve technologies

The first prototype of a transcatheter heart valve prosthesis was developed as far back as 1965 by Dr Hywel Davies. More than 40 years on, the market for these devices, which offer a minimally-invasive alternative for replacing diseased heart valves to conventional surgery, is growing at double-digit rates. In this article, Sarah Zanon, senior clinical project manager of D-Target*, discusses the competitive landscape of the transcatheter aortic valve implant market and also opportunities in the area of transcatheter mitral valve repair

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