title: The challenges surrounding preclinical testing in transcatheter device development and the implications on the clinic.
abstract: Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices. Expert commentary: The lifecycle of a device is complex, but the period of commercialization may be short with little time for manufacturers to recuperate the costs associated with device development and (pre) clinical testing. Regulatory bodies such as the FDA require comprehensive data on pre-clinical testing prior to considering approval of an investigational device exemption to start trials in humans, which should include some data on safety and efficacy of a device. Preclinical testing needs to evaluate a variety of factors, such biocompatibility, material performance, durability, toxicology, particulation, protection against user error and device malfunction, potential hazards, and many more.
authors.affiliation: a Division of Cardiology , Sidra Medical and Research Center , Doha , Qatar.
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.affiliation: b W.L. Gore & Associates, Inc., Structural Heart Business Leadership , Flagstaff , AZ , USA.
authors.forename: Jake
authors.initials: J
authors.lastname: Goble
authors.affiliation: a Division of Cardiology , Sidra Medical and Research Center , Doha , Qatar.
authors.forename: Ziyad
authors.initials: Z
authors.lastname: Hijazi
mesh_terms: D000818:Animals; D002404:Catheterization / Q000295:instrumentation*; D018795:Device Approval; D006801:Humans; D062307:Medical Device Legislation
keywords: FDA; Preclinical testing; animal testing; cardiac catheterisation; transcatheter devices