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Unformatted text preview: Medical Device Development Erica Shwarz Dhairya Pujara Yogesh Prasad Balajee 1 | P a g e 0 4 / 1 3 / 2 0 1 1 Requirement Specifications and Design features of Thrombectomy Devices Designing a thrombectomy device that can withstand the complexities of chronic thrombus platelets can deem to be a difficult task. Many fall short in several categories, such as being able to effectively penetrate the thrombus without having the device clog or break, designing the catheter to have “steer –ability” so that it is less likely to kink inside of the body and cause vessel damage, and some do not have the catheter size design specifications to tackle thrombus in the cardiovascular arterial walls. That being said, our device would have requirements such that these specifications are the main design considerations. Verification and Validation 1. Ability to penetrate chronic thrombus Chronic thrombus formation typically occurs when a vessel has sustained damage through plaque formation, typically calcium. Platelets such as thrombin and fibrin typically arrive and plaque formation, typically calcium....
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- Spring '11