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An ex vivo perfusion platform for the testing of cardiovascular interventional devices

Nature Reviews Cardiology volume 23, page 145 (2026)Cite this article

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The development of cardiovascular interventional devices, from drug-eluting stents to drug-coated balloons (DCBs), is hindered by a crucial bottleneck in the preclinical development pathway. The arteries of small animal models do not reflect the size and physiology of human arteries, thus often requiring device miniaturization that limits device performance. Large animal models, which are more anatomically relevant to humans, are costly and logistically demanding, making them suboptimal for the rapid, iterative prototyping required in early-stage device development. As a result, the transition of promising devices from benchtop characterization to in vivo testing remains inefficient owing to a long-standing gap in physiologically relevant, predictive preclinical testbeds. A system that mimics key features of coronary physiology outside the living system could help to overcome this gap.

Although the platform is broadly applicable for interventional device testing, we have optimized the system particularly for the evaluation of DCBs. The system is designed to meet key regulatory requirements, including the American Society for Testing and Materials (ASTM) standards F2394, which governs stent retention and fixation on delivery systems, and F3320, which outlines the characterization of DCB coatings for durability, uniformity and particulate release during simulated use. The platform facilitates the inflation and withdrawal of DCBs under controlled conditions, allowing the direct measurement of coating durability, particulate release and drug transfer to tissue. This preclinical, predictive analysis minimizes the risks associated with device development, accelerates iterative design optimization and establishes a foundation for future in vivo testing.

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Acknowledgements

T.T. acknowledges support from a British Heart Foundation (BHF) Fellowship (FS/ATA/21/20015), the BHF Centre of Research Excellence, the University of Oxford (BHF RE/24/130024) and a Wellcome Trust award (312718/Z/24/Z). The authors thank Keith Channon (University of Oxford, UK) for valuable discussions.

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  1. Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation (BHF) Centre of Research Excellence, University of Oxford, Oxford, UK

    Thomas Foster & Tanveer A. Tabish

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  1. Thomas Foster
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  2. Tanveer A. Tabish
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Correspondence to Thomas Foster or Tanveer A. Tabish.

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Competing interests

T.A.T. is the principal inventor on a UK patent application entitled ‘Nitric oxide-generating material’ (application 2319023.4 filed by Oxford University Innovation), which relates to nitric oxide-generating vascular stent coatings. This patent is not directly related to the drug-coated balloon work or the perfusion platform described in this article. T.F. declares no competing interests.

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Foster, T., Tabish, T.A. An ex vivo perfusion platform for the testing of cardiovascular interventional devices. Nat Rev Cardiol 23, 145 (2026). https://doi.org/10.1038/s41569-025-01243-x

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