First-in-man implantation of a novel percutaneous valve: A new approach to medical device development

Silvia Schievano, Andrew M. Taylor, Claudio Capelli, Louise Coats, Fiona Walker, Philipp Lurz, Johannes Nordmeyer, Sue Wright, Sachin Khambadkone, Victor Tsang, Mario Carminati, Philipp Bonhoeffer

Research output: Contribution to journalArticle

Abstract

Aims: To present our experience of 'first-in-man' implantation of a new percutaneous pulmonary valve into a dilated pulmonary trunk, using patient specific data to influence the design of the device and ensure patient safety. Methods and results: A 42-year-old with severe pulmonary insufficiency underwent computed tomography assessment of his pulmonary trunk. This information was utilised to create computer and rapid prototyping models that were used to customise and test the device, which was subsequently implanted into the patient. Following the procedure, the clinical, haemodynamic and morphological success of this approach was determined. The new device was safely and successfully implanted as predicted by the pre-procedural modelling. There was excellent device stability, no stent fractures, no pulmonary incompetence and only trivial para-device leak at six months follow-up. The patient described marked symptomatic improvement. Conclusions: Safe, effective percutaneous pulmonary valve implantation is possible in a patient with a dilated, native pulmonary trunk. Our methodologies, which have evolved as a direct result of recent advances in four-dimensional imaging techniques, challenge the conventional stepwise pathway of bench and animal testing prior to human application, and may be safer and more relevant, potentially reducing the number of animal experiments necessary for testing new medical devices.

Original languageEnglish
Pages (from-to)745-750
Number of pages6
JournalEuroIntervention
Volume5
Issue number6
DOIs
Publication statusPublished - Jan 2010

Keywords

  • Computed tomography
  • Congenital heart disease
  • Finite element analysis
  • Percutaneous valve
  • Rapid prototyping

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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    Schievano, S., Taylor, A. M., Capelli, C., Coats, L., Walker, F., Lurz, P., Nordmeyer, J., Wright, S., Khambadkone, S., Tsang, V., Carminati, M., & Bonhoeffer, P. (2010). First-in-man implantation of a novel percutaneous valve: A new approach to medical device development. EuroIntervention, 5(6), 745-750. https://doi.org/10.4244/EIJV5I6A122