The Food and Drug Administration medical device review process -: Clearance of a clot retriever for use in ischemic stroke

Many medical devices are properly evaluated as tools to accomplish a specific task. The incremental changes in design and the criticality of deployment techniques to safety and effectiveness are key features of medical devices that make them inherently different from drugs. Medical device regulation provides (and in fact, requires) the FDA to tailor the data requested from a manufacturer to address the specific safety and effectiveness questions that need to be addressed before a marketing authorization can be granted. In the case of the Merci Retriever, Concentric Medical provided data to demonstrate that the device is a safe and effective tool developed to meet the needs of the user community that could be used for removal of thrombus in the neurovasculature. The clinical trial that supported this clearance provided important safety information that led to improvements in the device design and in the instructions for use before marketing. The clinical user community may choose to conduct further research to develop more definitive outcome data for patients undergoing mechanical thrombectomy with devices such as the Merci Retriever. As these data are collected, to better refine the patient population and to quantify the expected benefit, FDA clearance of the Merci Retriever allows the device to be available as a useful tool for clinicians to treat patients for whom they believe mechanical thrombectomy may be of benefit, thus potentially reducing the devastating impact of ischemic stroke on the public health.