Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.
Study Type
OBSERVATIONAL
Enrollment
20
The Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.
Presence of bleeding
Primary endpoints are structured to encompass all clinical use outcomes characterizing device performance. Evaluation items directly related to the Bıçakcılar Vent Catheter will be measured using a Likert scale with values ranging from 1 to 5.
Time frame: It will be measured during the operation up to 6 hours.
Impact of trauma
It will be used a 5-likert scale.
Time frame: During the operation
Manipulation during placement
It will be used a 5-likert scale.
Time frame: During the operation
Cannula leakage
It will be used a 5-likert scale.
Time frame: During the operation
Gizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer
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