Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten – Das Beispiel Paclitaxel

Behrendt CA, Rother U, Rümenapf G, Uhl C, Görtz H, Böckler D (2020)

Publication Type: Journal article, Review article

Publication year: 2020

Journal

Abstract

In 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validity of this association, while various observational studies using clinical and administrative registries proved the safety of coated devices. This article aimed to summarize the development and adoption of paclitaxel-coated balloons and stents for the treatment of peripheral arterial occlusive disease in clinical practice, research, and practice guidelines. It especially focusses on the European Unionʼs medical device regulation, which has far-reaching implications for the market approval and monitoring of high-risk medical devices.

Authors with CRIS profile

Ulrich Rother Department of Vascular Surgery

Involved external institutions

Universitätsklinikum Heidelberg

Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE)

Germany (DE) Diakonissen-Stiftungs-Krankenhaus Speyer

Germany (DE) St. Bonifatius Hospital

Germany (DE)

How to cite

APA:

Behrendt, C.A., Rother, U., Rümenapf, G., Uhl, C., Görtz, H., & Böckler, D. (2020). Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten – Das Beispiel Paclitaxel. Gefässchirurgie. https://doi.org/10.1007/s00772-020-00713-5

MLA:

Behrendt, C. A., et al. "Randomisierte kontrollierte Studien und Real-World-Evidence in der Marktzulassung und Überwachung von Hochrisikoprodukten – Das Beispiel Paclitaxel." Gefässchirurgie (2020).

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