NuVasive®, Inc.
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Bone Grafting

Traditional bone grafting

The standard against which all bone grafts are measured is autograft, which is the patient’s own bone. Autograft contains all of the components for natural bone healing, including living cells. However, because a second incision is typically necessary to harvest enough bone, some potential drawbacks exist:

  • Longer surgical procedure
  • Harvest-site infection
  • Increased recovery time
  • Long-term pain

Additionally, not all patients are good candidates for autograft harvesting, due to inadequate bone quantity or quality.

For these reasons, alternatives such as allograft, bone graft from a tissue donor, are often used instead. Conventional allograft, however, lacks living cells and thus does not contain all of the components necessary for bone growth

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Your Surgeon May recommend Osteocel® Plus

In preparation for your surgical procedure, your surgeon is planning for your individual case. One consideration is the need for a bone graft material to encourage new bone growth. Because of the unique properties of Osteocel Plus, your surgeon may identify this material as the best option for you.

Surgical treatment of spine and orthopaedic conditions often requires the use of a bone graft material. Bone grafts promote growth of new bone for long-term stability. New bone grows and matures over a year or more, depending on the specific surgical procedure and the individual patient.

The ultimate goal of fusion is to restore disc height, alignment, and stability. In order to help promote fusion, NuVasive offers a line of biologics intended to help in the bone healing process.

Osteocel® Plus is a biologics solution for use in various musculoskeletal applications, including spine procedures, to facilitate fusion. An allograft cellular matrix containing viable mesenchymal stem cells, it mimics the biologic profile of autograft and contains all three natural components for bone healing: osteogenic cells, osteoconductive scaffold, and osteoinductive signals.

Osteocel® Plus advantages

Osteocel Plus was developed to mimic the patient’s own bone by providing all of the necessary bone-growing components:

Cells

  • Osteocel Plus contains living bone cells, including mesenchymal stem cells and osteoprogenitor cells. These bone cells are naturally present in our bodies and are essential for bone tissue formation and healing.  Osteocel Plus retains cells from adult tissue donors, avoiding the concerns associated with embryonic cells.

Signals

  • Mesenchymal stem cells and other elements of Osteocel Plus are able to send signals to the body’s own cells to involve them in bone formation.

Scaffold

  • Osteocel Plus also provides a scaffold, or support structure, for new bone to grow on and through.

Osteocel Plus provides a complete bone graft, since it contains all of the necessary components for bone growth: cells, signals, and scaffold.  Patients can now be treated with an advanced bone graft and avoid the limitations of traditional bone graft alternatives.

An advanced bone-grafting solution

Osteocel® Plus is an advanced form of allograft bone graft, which differs from traditional allograft in that the native bone cells are preserved.

Due to strict attention to FDA and American Association of Tissue Banks standards, recorded allograft-related infection rates have been much lower than those associated with the surgical procedures themselves.1,2 Over 1.5 million allografts are now implanted annually, with no recorded disease transmission since 2002 and no recorded HIV transmission in over 20 years.

Because Osteocel Plus contains living cells, specific processing techniques have been developed to support acceptance and incorporation of the graft by your body:

  • Tissue donors are thoroughly screened and tested to meet or exceed safety standards mandated by the FDA and the American Association of Tissue Banks.
  • Tissue is carefully cleaned and specifically processed to deplete components that could be rejected by your body and retain only elements to support bone growth.
  • Each and every lot of Osteocel Plus is meticulously tested, not only for safety, but also to confirm the presence of active cells for forming new bone.

Osteocel Plus has been used as an advanced bone grafting solution since 2005 in over 50,000 patients without any reported adverse events.

To find out more, discuss with your physician the reasons he or she believes Osteocel Plus will be helpful in your particular case.

1Am J Sports Med December 2007 35:2148-2158 (allograft-related infection rate: 0.0004%) 2NHSN Report, 2008 (spine-surgery related infection rate: 1.57%) 3AATB. www.aatb.org

FormaGraft® supplements the biologics offering as a scaffold for new bone growth. A synthetic biologic comprised of minerals naturally occurring in the body (hydroxyapatite and beta-tricalcium phosphate) and bovine collagen, when combined with bone marrow aspirate, FormaGraft offers the three necessary components for fusion.

Disclaimer:  Since medical care is tailored to fit individual needs, not all information presented here may apply to your treatment or its outcome. Seek the advice of your physician or other members of your healthcare team for specific information about your medical condition.

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