“Clinical Outcomes in Patients Treated With SternaLock Blu”
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.
Device - SternaLock Blu
Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.
Sternal Rigid Fixation: Evaluation of Clinical Outcomes Using Real-World Evidence