Sternotomy | Sternal Closure | SternaLock Blu Study

Sternotomy | Sternotomy Wires | Sternum Surgery Healing

Healing
Matters

Patients treated with SternaLock® Blu experienced improved and faster healing at three and six months.1

2.6x more patients healed at 3 months
 

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Sternotomy | Sternum Surgery Complications

Complications
Matter

Patients treated with SternaLock® Blu experienced fewer sternal complications.1

0% vs. 5% sternal complications rate
 

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Sternotomy | Sternum Surgery Recovery

Recovery
Matters

Patients treated with SternaLock® Blu spent fewer days in rehab hospitals or skilled nursing facilities.1,2,4

237 total fewer days in rehab and recovery
 

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Sternotomy | Sternotomy Wires | Sternotomy Cost

Cost
Matters

SternaLock® Blu resulted in total cost savings at 3 and 6 months.1,2
 

$1,888 savings per patient at 3 months
 

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Sternotomy Wires - comparison
Sternotomy Wires - comparison

Information presented is a summary 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

SternaLock® Blu Study

Rigid fixation is used to repair all fractures and osteotomies except sternotomies. As a leader in the musculoskeletal space, Zimmer Biomet recognized an opportunity to expand the benefits of rigid fixation to patients undergoing cardiac surgery.

The SternaLock Blu Study was designed by a team of expert cardiothoracic surgeons and leading health economic researchers, and compared outcomes following sternal closure with SternaLock Blu or wire cerclage. A total of 236 patients undergoing elective cardiac surgery were enrolled at 12 hospitals in the United States. Patients were followed for six months to evaluate healing, clinical outcomes and costs.

Patients treated with SternaLock Blu had improved sternal healing, fewer sternal complications and improved recovery. And, all of these clinical benefits were achieved at a cost savings.

The method matters. SternaLock Blu proves it.

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method matters.

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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

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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.

2 CR 0712E (Economic Study Report) SternaLock Blu Study, 2014-15, an evaluation of rigid fixation in supporting bone healing; a prospective, multi-center trial of 236 total patients undergoing full midline sternotomy.

3 Raman J, Lehmann S, Hatcher BM, et al. Sternal closure with rigid plate fixation versus wire closure, a randomized controlled multicenter trial. Ann Thorac Surg. 2012;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.

4 SternaLock Blu patients spent a total of 237 total fewer days in rehab hospitals or skilled nursing facilities over 6 months. 705 total days for wire cerclage patients (n=120) vs. 468 total days for SternaLock Blu patients (n=116).