What is SternaFuse bone allograft?

SternaFuse® is the first and only allogenic bone graft strip engineered specifically for use by cardiothoracic surgeons to reconstruct defects along the sternal edges for the prevention or repair of sternal non-unions. It has been successfully used since 2012 on over 1,800 high-risk patients.

SternaFuse Allograft Product Description

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The porous structure of SternaFuse serves as both a spacer to displace fibrous tissue formation and a scaffold for cellular infiltration and incorporation of native bone growth factors. Consequently, this promotes revascularization of the graft, allowing osteocytes an opportunity to bridge the defect and create new bone, rather than allowing scar tissue development.

The relevant orthopedic principles state that bone cells will not normally spontaneously bridge across a fracture gap of more than 2 mm, which also corresponds to an increase in the likelihood of non-union. (Gaston, J Bone Joint Surg., 2007)

SternaFuse® is a novel allogenic bone product specifically designed to easily reconstruct problematic sternal defects commonly seen in osteoporotic patients, non-union patients, or patients with any persistent fracture gaps after approximation.

The primary indication is to reconstruct the voids found in primary sternotomy patients with advanced osteoporotic sternal bone and who have erosion of the cancellous bone along the sternal edges. A secondary benefit of using SternaFuse® in this "frail bone" scenario is that its tiny, interconnected pores seem to reliably facilitate hemostasis.

Another indication is to treat the persistent bony gap following approximation that frequently results from the sternal debridement of scar tissue during a non-union repair, or from sternal retractor damage.

Fusion Innovations

Fusion Innovations specializes exclusively in developing devices and techniques for thoracic reconstructive surgery. In 2012, Fusion Innovations was the first to develop and introduce this technique specifically to cardiothoracic surgery -- the idea of using a "fusion strip" to reconstruct sternal defects. This fusion strip and its implantation method was then patented by Fusion Innovations.

The result of this effort was the SternaFuse allograft bone strip, which was designed with proprietary form and dimensions uniquely suited for use in the sternotomy site that facilitates implantation in two ways:

in primary sternotomies, the need for sizing alterations is replaced with a perfect fit, thus saving time and money by eliminating product waste.

in reconstructive applications, retention of the allograft within the sternal defect can be maintained with sutures either around or through the allograft.

SternaFuse is sterilized using a proprietary process, which provides a sterility assurance level of 10-6 in accordance with ISO standard 11137-2 Method 1. The process meets all FDA human tissue regulations (CFR 1271) and AATB standards. FEI 3011409233.

Contact

Tel: 888-316-7627

Fax: 1-800-616-5205

Beware of orthopedic/spine companies with imitation products that are merely repurposed spine allografts not designed to be used along the sternal edges. Consequently, these products may disintegrate during and after placement allowing the components to migrate into the mediastinum.

The SternaFuse® trademark is the property of Fusion Innovations. This material is for the sole use and benefit of surgeons and their staff. It is not to be redistributed, duplicated, or disclosed without the express written consent of Fusion Innovations.

Fusion Innovations and its subsidiaries do not practice medicine or give surgical advice. One should not act or rely upon information contained herein.