From The Patient. For The Patient.
Description and Intended Use
Please note: The PRP Tubes and PRFM Membrane Vials are to be used with Centrifuge Models Drucker DASH Flex 24 provided by Royal Biologics.
Point-of-Care, Autologous System
Step 1
Separate and Concentrate the Platelets
Step 2
Produce the Platelet-Rich Fibrin Membrane Graft
Step 3
Mix Platelet-Rich Fibrin Gel w/ Bone Grafting Material
Kit Components
- (3) PRP tubes (Yellow Stopper)
- (1) PRFG tube (Red Stopper)
- (1) PRFM Membrane Vial
- (2) Luer-Lok Transfer device (Red tip)
- (2) Luer-Lok Access device (Blue tip)
- (1) 20mm Vial Adapter
- (1) Safety-wing blood collection set
- (1) Latex-free Tourniquet
Standard Fibrinet® System Kit Contents:
- (5) PRP tubes (Yellow Stopper)
- (1) PRFG tube (Red Stopper)
- (2) PRFM Membrane Vial
- (2) Luer-Lok Transfer device (Red tip)
- (2) Luer-Lok Access device (Blue tip)
- (1) 20mm Vial Adapter
- (1) Safety-wing blood collection set
- (1) Latex-free Tourniquet
Clinical Evidence
The Fibrinet Osteo-Spin™ Accessory Kit is designed for use with the Fibrinet Standard Kit (REF 510359) and Fibrinet Mini Kit (REF 510358) . The kit is a one-time use disposable kit used for preparing Platelet Rich Plasma (PRP) or Platelet-Rich Fibrin Matrix (PRFM) Graft from a small sample of the patient’s blood.
The Fibrinet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
(1) Bowl/Spatula
REFERENCES
1. Sengupta DK, Truumees E, Patel CK. Outcome of Local Bone Versus Autogenous Iliac Crest Bone Graft in the Instrumented Posterolateral Fusion of the Lumbar Spine. Spine 2006; Vol. 31; 9:985-991.
2. Niu CC, Tsai TT, Fu TS. A Comparison of Posterolateral Lumbar Fusion Comparing Autograft, Autogenous Laminectomy Bone With Bone Marrow Aspirate, and Calcium Sulphate With Bone Marrow Aspirate. Spine 2009; Vol. 34; 25:2715-2719.
3. Brenner R, Zhang K, Abjornson C, Cammisa FP. Platelet Rich Fibrin Matrix in Posterolateral Lumbar Fusion. AAOS 2012.
4. Brecevich A.T., Kiely P., Abjornson C, Cammisa FP. A Retrospective Analysis of Platelet Rich Fibrin Matrix Use in Posterolateral Spine Arthrodesis. ISASS 2014.
5. Park JJ, Hershman SH, Kim YH. Updates in the Use of Bone Grafts in the Lumbar Spine. Bull Hosp Jt Dis. 2013; 71(1):39-48
6. Han B, Woodell-May J, Ponticiello M, Yang Z, Nimni M. The effect of thrombin activation of platelet-rich plasma on demineralized bone matrix osteoconductivity. J Bone Joint Surg. 2009; 91:1459-70.
7. DePaula CA, Truncale KG, Gertzman AA, Sunwoo MH, Dunn MG. Effects of hydrogen peroxide cleaning procedures on bone graft osteoinductivity and mechanical properties. Cell Tissue Bank. 2005;6:287–298.
8. Lucarelli E, et al. A recently developed bifacial platelet-rich fibrin matrix. Eur Cells Materials 2010; 20:13-23.
9. Roy S, Sen CK, et al. Platelet-rich fibrin matrix improves wound angiogenesis via inducing endothelial cell proliferation. Wound Rep Regen. 2011;19(6):753-766.
Simon BI, Zatcoff AL, Kong JJW, O’Connell SM. Clinical and histologic comparison of extraction socket healing following the use of autologous platelet rich fibrin matrix (PRFM) in ridge preservation procedures employing demineralized freeze dried bone allograft and membrane. Open Dentistry Journal. 2009;3:92–99.
11. Marx RE: Platelet-rich plasma (PRP): What is PRP and What is not PRP? Implants Dental 10:225-228, 2001.
12. Visser LC, Arnoczky SP, Caballero O, et al. Platelet-rich fibrin constructs elute higher concentrations of TGF-ß1 and increase tendon cell proliferation over time when compared to blood clots of similar volume: A comparative in vitro analysis. Vet Surg. 2010c; 39(7):811-817.
13. Castillo TN, Pouliot MA, Kim HJ, Dragoo JL. Comparison of growth factor and platelet concentration from commercial PRP separation systems. Am J Sports Med. ePub Nov 4, 2010.
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Royal is a pioneering leader in orthobiologic and wound care research and development. Royal’s commitment lies in delivering top-tier, innovative biologic solutions that enhance the healing process and improve patients' quality of life. Royal places patient well-being at the center of its mission, offering exceptional solutions to address a variety of complex needs.
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