Non-clinical functional studies are often needed to evaluate performance as well as the safety of a medical device under conditions of use.
In contrast to infra-renal repair, with its large evidence base and randomised control trials, most of the existing data on TEVR is from smaller industry run trials designed to evaluate the safety of a particular device.
New paradigms propose hierarchical modeling that combines premarket and postmarket data to illustrate the effectiveness and safety of a medical device throughout the total product lifecycle [ 25].
To help ensure the safety and efficacy of a device, we propose that regulatory agencies include pathology analysis by experienced, independent pathologists with relevant expertise as an integral component of device submissions.
In fact, beyond the safety and efficacy of a device or therapy, how an individual experiences that product just isn't a huge consideration.
To assess the efficacy and safety of a new surgical device designed to prevent adhesions.
To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery.
To test the safety of a novel miniaturized device that produces nitric oxide (NO) from air by pulsed electrical discharge, and to demonstrate that the generated NO can be used to vasodilate the pulmonary vasculature in rabbits with chemically-induced pulmonary hypertension.
We explored efficacy and safety of a transcutaneous VNS device (tVNS, Gammacore®) as preventive treatment in primary headache sufferers.
This prospective, monocentric, observational, open clinical study aimed to assess the feasibility and safety of a new esophageal device to perform TTM in such patients.
