Healing Matters

Sternotomy | Sternotomy Wires | Sternum Surgery Healing

Healing Matters

Information presented is a sumary of study results and should not be construed as a substitute for reviewing the actual study itself. All results are comparisons to wire closure.1

Following cardiac surgery, sternal stability is a key factor that supports sternal healing, reduces the risk of sternal complications and can improve patient recovery. Rigid plate fixation of the sternum has been shown to provide enhanced stability compared to wire cerclage, and in turn leads to improved healing.

In the SternaLock Blu Study, the gold standard for assessing bone healing was used to evaluate sternal healing. CT scans at three and six months demonstrated that patients treated with SternaLock Blu experienced improved and faster healing than patients treated with wire cerclage. At 3 months, 2.6x more patients with SternaLock Blu had sternal healing than wire cerclage patients, and by 6 months, 80% of SternaLock Blu patients had sternal healing. The use of SternaLock Blu also mitigated the negative impact on sternal healing of various patient risk factors, including age, BMI and smoking.

Patients with SternaLock Blu experienced improved and faster healing at three (p < 0.0001) and six (p = 0.04) months.1

Sternotomy - Improved Healing
Sternotomy - Improved Healing
Sternotomy - Faster Healing
Sternotomy - Faster Healing
Sternotomy - Predictors of Sternal Healing
Sternotomy - Predictors of Sternal Healing

3 Months
Patient risk factors that were found to negatively impact sternal healing included older age (p = 0.01), higher BMI (p = 0.008), and smoking (p = 0.02). The strongest predictor of improved sternal healing is closure with SternaLock Blu (p < 0.01).

6 Months
Patient risk factors that were found to negatively impact sternal healing included older age (p = 0.001), higher BMI (p < 0.001), and smoking (p = 0.01). The strongest predictor of improved sternal healing is closure with SternaLock Blu (p = 0.002).

Sternotomy - Nonunion Treatment
Sternotomy - Nonunion Treatment

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RISK INFORMATIONSternaLock Blu
SternaLock 360

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SternaLock Blu

Patient Risk Information

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INDICATIONS

The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.

CONTRAINDICATIONS

  1. Active infection
  2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
  3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Download Complete SternaLock Blu IFU (pdf)

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SternaLock 360

Patient Risk Information

Download PDF

INDICATIONS

The SternaLock 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

CONTRAINDICATIONS

  1. Active infection
  2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
  3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Download Complete SternaLock 360 IFU (pdf)

1 CR 0712S (Clinical Study Report) SternaLock Blu Study, 2014-15, an evaluation of rigid plate fixation in supporting bone healing: a prospective, multi-center trial of 236 total patients undergoing full midline sternotomy.