Cellular bone matrix (CBM)

SygnaCel™ cellular bone matrix (CBM)

<p>SygnaCel™ CBM combines human cryopreserved cortical cancellous bone matrix and demineralized bone fibers for use as a bone graft in spine fusion procedures.</p>

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Indications, Safety, and WarningsSygnaCel™ CBM important informationDescriptionSygnaCel™ cellular bone matrix is a formulation of human cryopreserved viable cortical cancellous bone matrix and demineralized bone fibers.Indications for useSygnaCel™ cellular bone matrix can be used as a bone graft in orthopedic or reconstructive procedures. Use SygnaCel™ cellular bone matrix in combination with autologous bone and/or bone marrow aspirate.SterilitySygnaCel™ cellular bone matrix is labeled as “aseptically processed, passes USP sterility tests.” It was aseptically processed and tested for sterility according to the current United States Pharmacopeia.ContraindicationsThe presence of infection at the implantation site is a contraindication for the use of this allograft.Warnings

SygnaCel™ CBM is a cellular bone matrix product containing viable cells.

Bone matrix products containing viable cells have been linked to, or associated with, two Mycobacterium tuberculosis (Mtb) outbreak events in the United States.

Some affected by these outbreaks have died.

Current donor screening, processing, and testing cannot fully eliminate the risk of disease transmission from bone matrix products containing viable cells.

Potential adverse eventsDonor screening methods are limited. Therefore, certain diseases and infectious agents may not be detected and/or eliminated during processing. The following complications of tissue transplantation may occur:

Loss of function or integrity of transplanted tissue due to resorption, fragmentation, or disintegration including associated loss of continuity, or displacement, and/or fracture at treatment site

Non-union (or pseudarthrosis), delayed union, and/or mal-union

Immune rejection of transplanted grafts or infection

Transmission or causation of known diseases as well as diseases of unknown etiology and characteristics

Transmission of known infectious agents including HIV, hepatitis B, hepatitis C, and bacteria (e.g., syphilis, Mycobacterium tuberculosis)

Death

CautionThis allograft may contain trace amounts of processing agents. Caution should be exercised if the patient is allergic to any of these agents.PrecautionsDespite extensive donor selection and qualification processes, transmission of disease is still possible. Bacterial or fungal infection may also occur.Donor screening and testingThe donor was screened in accordance with FDA regulations and standards established by the AATB. The donor was also screened for HIV, Hepatitis, and CJD/vCJD risk factors. Donor blood was tested for communicable disease by a laboratory registered with the FDA using FDA approved, licensed, or cleared tests. Results of tests were negative or non-reactive. Laboratory-developed Mtb NAT (nucleic acid amplification testing) and culture testing for Mtb was also performed. Note that there are currently no FDA approved tests for Mtb detection in cadaveric tissues. Testing for Mtb may not detect inactive (latent) mycobacteria.For a complete list of indications, safety, and warnings, please visit manuals.medtronic.com

Features

Vibrant Signal —
key for MSC to bone cell differentiation

1.8 OI score^†,¹High osteoinductivity demonstrated through bone formation in an athymic rat muscle pouch.

325,000 viable cells/cc²Measured live cells naturally present in bone, such as MSCs, osteoprogenitors, and osteoblasts with Trypan blue in digested samples.

99% cell viability at 1 hr³Long-use window post-thaw is demonstrated by 80% cell viability at 5 hours.

† Animal testing is not necessarily indicative of human clinical outcomes.

Hassle-free prep –
prioritizing OR efficiency

3-6 min

Rapid thaw: 3-6 min⁴Reduces ice crystal formation to enhance cell viability⁵ and ensures quick availability for immediate use.

No decanting or rinsing of cryoprotectant⁴DMSO-free biocompatible cell-friendly cryoprotectant provides high cell viability.

User-friendly packaging⁶Pouch packaging allows easy access to graft and minimizes the product footprint in the freezer.

Surgical versatility —
a single solution for MIS and open surgeries

Accelerate™ graft delivery system compatible⁷Allows for delivery of SygnaCel™ CBM with local bone for faster, uninterrupted and precise placement of bone graft while providing real-time tactile feedback.

Proprietary fiber technology⁷Enhances cohesivity and minimizes shedding when mixed with autograft, enabling surgeons to mold and pack the product effectively for fusion.

Robotic guided delivery⁸Can be delivered with the Mazor™ 5.1 robotic guidance system for facet fusion.

Ordering information

Item number	Description	Number of cannulas
T90101	CBM T90101 SygnaCel™ 1 cc	0
T90102	CBM T90102 SygnaCel™ 2.5 cc	2
T90105	CBM T90105 SygnaCel™ 5 cc	4
T90110	CBM T90110 SygnaCel™ 10 cc	4
T90115	CBM T90115 SygnaCel™ 15 cc	6

Resources

SygnaCel™ Cellular Bone Matrix (CBM) Brochure (open in new window)

Learn about SygnaCel™ cellular bone matrix (CBM), a bone augmentation technology used in spinal fusion surgery.

PRODUCT PDF 9 MB

View the SygnaCel™ CBM processing enhancements.

SygnaCel™ Cellular Bone Matrix (CBM) Safety Enhancements (open in new window)

See an overview of enhancements implemented in SygnaCel™ cellular bone matrix (CBM) processing.

PRODUCT PDF 323 KB

SygnaCel™ CBM Preparation and Handling Video (open in new window)

See an overview of SygnaCel™ CBM prep and handling video that includes use with Acclerate™ graft delivery system Product. MP4. 320MB

PRODUCT MP4 312 MB

†Animal testing is not necessarily indicative of human clinical outcomes.

1. Animal data on file (2024). Average score based on n=8 lots.
Internal benchtop testing data on file (2024). Average based on n=7 lots.
Average based on internal benchtop testing data (2024)
SygnaCel™ CBM IFU
Linkova DD, Rubtsova YP, Egorikhina MN. Cryostorage of Mesenchymal Stem Cells and Biomedical Cell-Based Products. Cells. 2022;11(17):2691 6.
Data on file based on survey (2024)
Internal validation testing data on file
Internal data on file

SygnaCel™ cellular bone matrix (CBM)

Features

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