Overview of Autograft and Autologous cell harvesting products
Autologous bone and bone marrow aspirate (BMA) are rich in high-quality, osteogenic cells and native growth factors ideal for bone regeneration.1 Medtronic offers the Corex™ minimally invasive bone harvester and the Marrow Cellution™ bone marrow aspirate (BMA) and stem cell harvesting system, each are capable of delivering viable, autologous cells from various surgical sites.
Autograft may be extended with Medtronic allograft extenders like Magnifuse™, Grafton™, or the Mastergraft™ family of synthetic bone grafts.
INDICATIONS: COREX MINIMALLY INVASIVE BONE HARVESTER
The Corex bone harvester is a supplied sterile single patient use, manually operated trephine intended for harvesting cancellous bone from various skeletal sites. Device is a single patient use item. Reuse may result in failure of proper actuation and or biologic contamination. These consequences could result in adverse patient effects. Extreme caution should be utilized when placing the sharp tip of the device near vulnerable, “at risk” structures.
PRODUCT DETAILS: COREX MINIMALLY INVASIVE BONE HARVESTER
Corex quickly recovers the patient’s bone in an intact cylindrical form through a small incision with minimal tissue disruption, providing the surgeon autologous bone that contains growth factors for bone regeneration.1 Harvesting from the iliac crest, proximal femur and distal femur is performed with the trocar entering through a single incision. Surgeons can then reposition the angle to harvest from multiple internal pathways. This trocar is designed to reduce operative time and blood loss. The Corex bone harvester is compatible with Medtronic’s demineralized bone matrix (DBM) and synthetic bone products that are cleared for use with autologous bone.
Once the trocar tip is removed, Corex’s trephine (hollow tube section) is not intended to further penetrate cortical bone. There are circumstances of use when cortical penetration might occur, or is even likely to occur. The surgeon must be keenly aware of this potential hazard, as serious or life-threatening injuries to nerves, vessels, or other soft tissue structures external to the bone’s cortical margins may result. The surgeon should understand the orientation and depth of penetration associated with the Corex cutting tip, relative to the skeletal anatomy within which it is being applied. Every effort to ensure that the cutting tip remains within the cancellous portion of the bone should be exercised. If there is any doubt, the device’s depth of entry and axial orientation should be measured and noted and, if appropriate, the device should immediately be withdrawn from the bone entry site.
Warning: Extreme caution should be utilized when placing the sharp tip of the device near vulnerable, “at risk” structures.
Warning: BE MINDFULL OF PENETRATION DEPTH WHEN DIRECTING HARVESTER TOWARD SCIATIC NOTCH. THE DISTAL ASPECT OF THE SECOND APPETURE IS 5CM FROM THE TIP OF THE TREPHINE.
INDICATIONS: MARROW CELLUTION BMA AND STEM CELL HARVESTING SYSTEM
The Marrow Cellution needle is intended for use for bone marrow aspiration or autologous blood using a standard piston syringe.
PRODUCT DETAILS: MARROW CELLUTION BMA AND STEM CELL HARVESTING SYSTEM
Our synthetic bone grafting products can be enhanced by combining cellular-rich bone marrow aspirate using the Marrow Cellution needle kit. Our Marrow Cellution needle kit provides a safe and simple technique for aspirating marrow and/or autologous blood from the iliac crest or vertebral body.
With the Marrow Cellution needle, you can retrieve high-quality bone marrow from numerous sites within the marrow geography with a single puncture. The needle is designed to aspirate and recover perpendicular to and around the channel, avoiding peripheral blood infiltration. The needle improves stem progenitor cell recovery while reducing peripheral blood infiltration.2
Marrow Cellution:
Allows for the collection of the patient's own cells
Maximizes stem and progenitor cell recovery, minimizes peripheral blood infiltration2
Has unique design that allows single puncture that can retrieve high-quality BMA from numerous sites within the marrow geography
Has higher colony forming units (CFU) counts than competitive technologies2
Higher CFUs correlate to improved clinical outcomes3,4,5
Marrow Cellution versus Centrifugation Systems and Traditional Aspiration Needle
CFUs are a better bone forming metric than total nucleated cells (TNCs). The patient’s own BMA provides autologous, fresh, unprocessed living bone forming cells.
MARROW CELLUTION: CONTRAINDICATIONS
Use only for bone marrow or autologous blood aspiration as determined by a licensed physician. The device is intended to be used by a physician familiar with the possible side effects, typical findings, limitations, indications and contraindications of bone marrow aspiration. The procedure should be performed on patients that are suitable for such procedure only.
MARROW CELLUTION CAUTION:
For single patient use only. The design of this device may not perform as intended by the manufacturer if it is re-used. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device. After use, this product may be a potential biohazard. Handle in a manner, which will prevent accidental puncture. Dispose of in accordance with applicable laws and regulations. Carefully place the used needle in a sharps biohazard container after the procedure is completed.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
SMART STORAGE COMPATIBLE
The Smartstorage™ System is an RFID-based, near real-time tissue tracking system that streamlines inventory management. No more worrying about manual recordkeeping — the Smartstorage System keeps accurate usage history and temperature logs. The system also notifies you when conditions need to be checked and assures precise accountability.
MANUALS AND TECHNICAL GUIDES
Find technical manuals in the product labeling supplied with each device or call Medtronic at 800-961-9055.
Myeroff C. et al. Autogenous Bone Graft: Donor Sites and Techniques. JBJS. 2011; 93:2227-36.
2
Harrell DB, et al. Novel Technology to Increase Concentrations of Stem and Progenitor Cells from Marrow Aspiration. White Paper 2016.
3
Hernigou P. et al. Percutaneous Autologous Bone-Marrow Grafting for Nonunions. JBJS. 2005 July; 87(A): 1430-1437.
4
Hernigou P. et al. Treatment of Osteonecrosis with Autologous Bone Marrow Grafting. Clinical Orthopaedics and related research. 2002 Dec; 405: 14-23.
5
Pettine K. et al. Percutaneous Injection of Autologous Bone Marrow Concentrate Cells Significantly Reduces Lumbar Discogenic pain Through 12 Months. Stem Cells 2015; 33: 146-156.
