Sternal Closure With SternaLock 360: First in Man Study

Exclusion Criteria

• •Patients with endstage renal failure who are on dialysis or post transplant patients
• •Patients taking chronic (\>30 days) pre-operative narcotics
• •Patients taking chronic (\>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
• •Patients with confirmed HIV with a viral load of \>10,000 copies
• •Patients with an active infection that is currently being treated
• •Patients with history or confirmed metal allergy or foreign body sensitivity
• •Patients with a previous partial or full midline sternotomy
• •Patients with previous radiation treatment of the chest
• •Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
• •Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
• •Patients unwilling or unable to return for follow-up
• •Patients requiring delayed sternotomy closure
• •Patients with transverse sternal fractures located beneath the cerclage band on the SternaLock 360 Device.
• •Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude a specific method for sternal closure, or who are not able to be closed per the protocol.
• •Use of non resorbable (beeswax) bonewax along the sternotomy