16 To maximize the likelihood that infections were device-related, claims were searched for patient records with at least 1 infection diagnosis that included a device procedure code for removal or revision during the same encounter; then claims were searched for device infection based solely on ICD...
Recognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involve
Desmopressin and VWF-containing concentrates are treatment options in VWD, but are ineffective in LVAD patients, with removal of the device being the only definitive treatment. Overall, AvWS is a condition that has implications beyond the LVAD population and should be recognized by otolaryngologists...
The removal of the interstage filters64and68causes the duplexer60to take over the functions of the interstage filters. That is, the filter in the duplexer60is required to have suppression performance corresponding to two filters. Particularly, it is required to improve the isolation characteristic of...
The device may be designed, configured, and constructed from with a single, unitary, tube, followed by the removal, for example, by mechanical cutters or by laser cutting, selected material from the tube, until only the desired geometry, shape, and dimensions of the tube and the apertures re...
Significant findings, including polyps > 6 mm in size or > 3 polyps regardless of size, should prompt conventional colonoscopy for removal. If, on the other hand, no significant lesions are found, then CCE or an equivalent screening test should be repeated in 5 years for surveillance...
Besides using the Neurosky device’s original noise-removal algorithm, we also introduced our own eye-blink detection (Section 3.2.2) and noise-removal algorithm to minimize the influence of eye blinks on EEG readings. 3.1.3. Participants and Procedure In total, 18 participants (8 females, ...