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SmartPRep2 – APC and BMAC

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SmartPReP®2 BMAC™

The innovation continues with an important expansion to the SmartPReP 2 technology platform. Iliac crest graft harvesting remains today's gold standard. However, autograft tends to be time consuming and the literature suggests that site morbidity issues arise in as many as 30% of the procedures. Consequently, there has been a real impetus to develop alternatives that replicate autograft's performance while reducing or eliminating the associated complications. The Harvest SmartPReP 2 technology platform is the first practical point-of-care tool designed to concentrate a buffy coat from whole blood marrow aspirate. In less than 15 minutes, the SmartPReP 2 system simultaneously isolates and concentrates:

1. Autologous Stem Cells from bone marrow aspirate - BMAC Series
2. Autologous Growth Factors from peripheral blood - APC+ Series
3. Autologous Thrombin activator to stimulate and initiate the release of growth factors - HAT*

Performance

There has been a lot of excitement regarding the use of bone marrow derived stem cells; especially in orthopedics as a potential to eliminate the complications associated with iliac crest graft harvesting. Consequently, it is critical to choose a technology platform that is not only documented to reliably concentrate all the stem and accessory cells but also concentrates these cells without diminishing their biologic potential.

As an example, selective retention techniques are less than optimal processing systems. The process routinely fails to capture a large number of cells present in the bone marrow aspirate. Furthermore, the end product is limited in the types of cells, molecules and proteins it is able to recover from bone marrow and return to the patient.

Unlike these selective retention techniques, the SmartPReP BMAC system is designed to concentrate a buffy coat from whole bone marrow aspirate. Because a buffy coat is a physiological fraction, it contains the total compliment of all stem cell types as well as platelets and other soluble factors that play a role in skeletalgenesis.

Hernigou, et al, (Percutaneous Autologous Bone Marrow Grafting -influence of the Number and Concentration of Stem Cells, JBJS), showed healing of non unions in patients receiving > 1,500 CFU-F/cm3

Quality

The method used for concentrating stem cells has a direct impact on the stem cells. In order to deliver enough progenitor cells, the stem cells not only need to be concentrated but concentrated in such a way as to leave them viable and functional. Stem cells concentrated using the SmartPReP BMAC system meet these critical criteria.

When concentrated BMAC stem cells and commercially available hMSC's (used as a control) are exposed to Mesenchymal Stem Cell culture media, the BMAC culture demonstrated a retained capacity for cell division and maintain normal morphology when compared to the control hMSC cells.

When concentrated BMAC stem cells and commercially available hMSC's are exposed to an osteogenic differentiation medium (ODM), the BMAC cells and control cells retained their ability and potential for osteoblastic differentiation.

Bright areas represent new deposition elements. Finally, when concentrated BMAC stem cells are exposed to Von Kossa silver stains, the BMAC cells demonstrated osteoblastic differentiation as evidenced by the vacuoles with black stain indicating deposited calcium.

Reliability

The SmartPReP 2 BMAC system simultaneously delivers speed, performance, dependable results while eliminating the time and guesswork associated with other modalities. The unique automated dual-spin and decanting process coupled with self-calibrating disposables ensures consistent and reproducible end product.

* An aggregate of cells containing more than 50 Fibroblasts was scored as a colony.

Hardware

Hardware system for the concentration of autologous bone marrow stem cells.
SMP-2: SmartPReP 2 Platelet Concentrate System 110V-50/60Hz.
SMP-2i: SmartPReP 2 Platelet Concentrate System 240V-50-60Hz
WS-2: SmartPReP2 BMAC Workstation
BW-60: Reusable Counter Balance Weight for SmartPReP 2
Designed for use with the BMAC 60-1 as the counter balance weight. 1/each.

BMAC Disposables

BMAC Procedure Packs

Includes components for 10 ml of BMAC. 1/case. The BMAC 60 autologous stem cell concentrate pack contains all the components needed for BMAC+ in one convenient kit. The BMAC 60 is designed to process 60 ml of bone marrow aspirate, which produces approximately 10 ml of BMAC. (The BMAC 60 requires the use of a BW-60 counter-balance weight.)

Bone Marrow Aspiration Pack:

• Aspiration Needles (2) and Stylets (4)
• 20 ml Aspiration Syringes (6)
• 5 ml Syringe
• Blood Transfer Bag
• Bag Spike Assembly
• 60 ml Transfer Syringe
• Blunt Transfer Needle
• 10 ml Transfer Syringe w/female/femaile luer (2)

Bone Marrow Procedure Pack:

• 60 ml Bone Marrow Process Disposable (PD)
• 30 ml Plasma Syringe with Blunt Cannula and 2 Spacers
• 20 ml Cell Concentrate Syringe with Blunt Cannula
• 10 ml Anticoagulant Syringe/Needle Assembly
• ACD-A 30 ml Anticoagulant, USP

BMAC 120 Procedure Pack for SmartPReP 2

Includes components for 20 ml of BMAC. 1/case. The BMAC 120 autologous stem cell concentrate pack contains all the components needed for BMAC+ in one convenient kit. The BMAC 120 is designed to process 120 ml of bone marrow aspirate, which produces approximately 20 ml of BMAC.

Bone Marrow Aspiration:

• IV Site Prep Kit
• 19 g IV Fistula
• 60 ml Blood Draw Syringe Assembly (2)
• 5 ml Anticoagulant Syringe Assembly
• ACD-A 30 ml Anticoagulant, USP

Bone Marrow Procedure Pack:

• 60 ml Bone Marrow Process Disposable (PD) (2)
• 30 ml Plasma Syringe with Blunt Cannula and 2 Spacers (2)
• 30 ml Cell Concentrate Syringe with Blunt Cannula (2)
• 10 ml Anticoagulant Syringe/Needle Assembly
• ACD-A 30 ml Anticoagulant, USP

BMAC Bone Graft Applicators

The BMAC Graft Delivery Pack facilitates the pre-mixing of bone graft materials with bone marrow aspirate concentrate and ultimate delivery of the graft composite to the surgical site

GDP-10 Graft Delivery Pack for pre-mixing bone graft materials and bone marrow

• Syringe/Piston/Female-Female Luer Assembly
• Mixing Nozzle
• 10 ml BMAC Syringe
• 1 ml Activator Syringe
• Stabilizer Clip
• Pusher Assembly
• Petri Dish
• Gauze Pad

Indications

The following is provided as a reference regarding the regulatory status of the SmartPReP® Centrifuge System (510k numbers K991430, BK000037, and K052925) and the Graft Delivery System (510k number K043261)

SmartPRep 2 Bone Marrow Processing

The SmartPReP 2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of cell concentrate from bone marrow.
Warning: The safety and effectiveness of this device for in-vivo indications has not been established.

Harvest Graft Delivery System

The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other fluids.  The system is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site.  In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. Fluids, blood, plasma, platelet rich plasma, bone marrow, or other specific blood component(s) as deemed necessary by the clinical use requirements.