Spine

Product

Procedure

The AlloSync bone grafting solutions line is a comprehensive offering of advanced DBMs for various bone grafting needs. AlloSync bone grafts contain osteoconductive and osteoinductive properties, providing the optimal signaling and scaffold for bone remodeling.
The unique geometry of AlloSync Expand 100% demineralized bone is ideal for intraoperative handling and controlled expansion into bone voids. AlloSync Expand fibers come preloaded in a syringe that allows for consistent hydration of the graft with biologic fluids, such as bone marrow aspirate (BMA).
AlloSync Pure DBM is derived from 100% demineralized cortical bone with no extrinsic carriers. When prepared, AlloSync Pure DBM will resist irrigation and can be used in a fluid environment. The clinician can control the handling properties of AlloSync Pure DBM, including decreasing viscosity of for injectable applications or increasing viscosity to add autograft bone. AlloSync bone grafts can be hydrated with fluids including platelet-rich plasma or concentrated BMA.

Orthobiologics

The unique long-strand geometry of AlloSync™ Expand 100% demineralized cortical fibers maximizes graft cohesion1 and provides a 3D interconnected matrix to promote cell migration across the bone void. AlloSync Expand fibers have demonstrated superior bone-forming capacity compared to standard particulate demineralized bone marrow.2 After hydration, the graft will expand to fill the void and create endplate-to-endplate contact in spinal fusion cases. AlloSync Expand fibers can be hydrated with biologic fluids, such as platelet-rich plasma or concentrated bone marrow aspirate.
References
1. Walsh WR, Lovric V, Russell N, Kim P, Larson MJ, Vizesi F, et al. Improved performance of SeaSpine demineralized bone fibers vs. three commercially available demineralized bone matrix products in an athymic rat posterolateral fusion model. IsoTis – Clinical Affairs. 2020.
2. Martin GJ, Boden SD, Titus L, Scarborough NL. New formulations of demineralized bone matrix as a more effective graft alternative in experimental posterolateral lumbar spine arthrodesis. Spine. 1999;24(7):637-645. doi:10.1097/00007632-199904010-00005.

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AlloSync™ Expand Demineralized Cortical Fibers for Spinal Fusion Cases

AlloSync™ Bone Grafting Solutions

Child (D)

Arthrocell is a viable bone allograft that contains cellular, scaffold, and gel components derived from human bone. The microparticulate scaffold is comprised of a proprietary blend of cortical and cancellous allograft bone. The bone-derived gel component provides optimal handling and resists irrigation. The cellular component consists of mesenchymal stem cells (MSCs), osteoprogenitor cells and pluripotent cells.

Don Kucharzyk, DO (Crown Point, IN), discusses the use of ArthroCell™ viable bone allograft in spinal fusion procedures. He also reviews two cases in which he incorporated ArthroCell grafts into multilevel fusions.&nbsp;

ArthroCell™ Viable Bone Graft for Spinal Fusion Procedures

I'm Doctor Donald Kucharczyk, a board certified orthopedic surgeon practicing in Northwest Indiana. Today, we're going to spend a little time talking about the role of Osteo Biologics in spinal fusion surgery. As we've seen over the past decade, there are multiple choices available in terms of Osteo Biologics for the surgeon when performing a fusion. The biologic of choice made by the surgeon should meet the criteria and feature what I call the holy triad for fusion. That is, it must possess Osteogenic potential, an Osteoinductive platform and an Osteoconductive matrix. All of these, we know are critical for the cascade of fusion to start, continue, and progress to solid arthrodesis. Arthrocell osteo biologic from Arthrex possesses all of these traits and more. It's a moldable cellular allergenic non-immunogenic bone matrix. It possesses an HTTP allogenic bone scaffold, and it derives the cells from the vertebral body, which, according to the literature, delivers better osteoprogenitor cells than that from the iliac crest, which other osteo biologics utilize cell viability and function is preserved utilizing a novel cryoprotectant that does not require decanting. Unlike similar products in the marketplace, this limits the time required for preparation to placement of the biologic, but more importantly by not decanting. This eliminates some potential sources of error and damage to the biologic that can occur with other products in the marketplace. So, as with anything, it's always important to see how a product works and see how it behaves in a surgeon's hands. And here are a few case presentations. This is a 56 year old lady who had low back pain with bilateral leg pain. She had a history of two prior microdiscectomy and one laminectomy at the four, five and five S1 level. The patient showed weakness to the quadriceps, to the anterior tibialis, the extensor hallucis longus, and gastrocnemius. The patient showed an absent patellar and Achilles reflex on the right and an absent Achilles reflex on the left. The patient had failed conservative treatment and care with medications, physical therapy, and Therapy and epidurals. The patient underwent workup that included x rays and an MRI scan that confirmed pathology at the three, four, four, five, and five S1 level with facet arthropathy central and lateral recess stenosis, as well as spinal instability that was noted on bending films. In addition, the patient also had multiple risk factors being a diabetic, hypertensive, and also having multiple surgical interventions prior to surgery. This is the patient after undergoing surgery at a multi-level fusion two weeks post-op. What we're looking for is, is the bone graft in the posterior lateral gutter. And we see the proper placement of the graft, and we see that it's spanning the area from L3 to S1. This is the patient now at three months. What we're looking for when we look at this is the consolidation and incorporation of the osteo biologic, the development of new bone formation and trabecular bone that's bridging from transverse process to transverse process all the way down onto the sacrum. And then when we look at this at six months, we see further incorporation and enhancement of the osteo, biologic and bone graft in the posterior lateral gutter. And here is the is the patient. Now at nine months bridging bone going from transverse process to transverse process and solid incorporation of the osteo biologic with no pseudoarthrosis lines. And what we don't see is any evidence of any hardware failure or lucency around the screws or the hardware. The next patient is a 68 year old that had progressive back pain and leg pain with the diminished ability to walk. She would notice that she would develop leg pain when she was ambulating, and would even have to have time to sit down and rest. She would notice numbness and tingling and at times weakness to her legs. The more she tried to walk, the patient failed conservative treatment with medications, epidurals, and physical therapy. She had MRI scans that confirmed the pathology of degenerative spinal disease with spinal stenosis. She showed facet arthritis, lateral recess, and neuro stenosis at the l45 and l5-s1 level with a grade one spondylolisthesis that was unstable at L4 five. The patient also carried risk factors that included hypertension, Diabetes and the fact that she had a previous decompressive laminectomy at the l5-s1 level. This is the preoperative x ray standing AP and lateral imaging. On the top image, we see the spine to show a relatively straight appearance to the spine, with no evidence of any scoliosis or curvature. We see prior decompressive laminectomy at the l5-s1 level. On the lateral image, we see an l45 spondylolisthesis with degeneration would collapse of the l5-s1 level. This is her forward bending and backward extension imaging that shows progression of the grade one spondylolisthesis with translation and a change of the intervertebral angle at L 45. It also shows a change in the intervertebral angle at l5-s1 with a relatively stable l34. The patient was taken to surgery and a two level spinal instrument at fusion was carried out. This is the AP and lateral imaging showing proper placement of the screws, inner bodies and posterior lateral bone grafting. This is the patient now at three months where we see incorporation of the of the Osteo Biologic bridging Bone, new bone formation and consolidation with no pseudoarthrosis lines. This is the patient now out at six months where we see further progression to the fusion. Further incorporation, further consolidation and no evidence of any pseudoarthrosis lines and no evidence of any loosening of the hardware. Finally, we see this image at nine months. So in complete bridging of the bone from L4 to S1, solid incorporation with new bone formation bridging trabecular bone, and no further progression of any hardware failure or loosened lines around the hardware indicating any evidence of any nonunion. In conclusion, ArthroCell osteo biologic offers for me in my practice convenience and ease of use. No decanting. It also provides what I consider important in fusion, the holy triad for fusion, which is critical to achieving a solid Arthrodesis. Good patient outcomes and good surgical outcomes. Thank you.

ArthroCell™ Viable Bone

The BoneSync™ filler portfolio provides surgeons with several bone void solutions with excellent handling characteristics. These products provide an osteoconductive scaffold and can be hydrated with biologic fluids such as bone marrow aspirate to optimize bone remodeling potential.1,2
The BoneSync portfolio includes:
<ul>
 <li>BoneSync putty</li>
 <li>BoneSync strips</li>
</ul>
References
1. Cho AR, Kim HK, Kwon JY, Kim TK, Choi YM, Kim KH. Pain Physician J. 2014;17(6):E737-E745.
2. Chen JC, Ko CL, Shih CJ, Tien YC, Chen WC. J Dent. 2012;40(2):114-122. doi: 10.1016/j.jdent.2011.11.003.

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BoneSync™ Putty and Strips

BoneSync™ BioActive is a second-generation synthetic bone void filler that elicits osteoconductivity and osteostimulative potential, allowing for bony ingrowth across a fracture or fusion site.1 Comprised of a sophisticated trio of components that includes bioactive glass, BoneSync BioActive filler provides healing benefits to patients and is available in a variety of sizes in strip and putty forms.
 
Reference
1. Xynos ID, Hukkanen MV, Batten JJ, Buttery LD, Hench LL, Polak JM. Bioglass 45S5 stimulates osteoblast turnover and enhances bone formation In vitro: implications and applications for bone tissue engineering. Calcif Tissue Int. 2000;67(4):321-9. doi:1.1007/s002230001134

BoneSync™ BioActive Synthetic Bone Void Filler

The GraftNet XL bone collection device allows for efficient and large volume collection of autologous bone. With unique features that allow for efficient OR workflow integration and quick access to autologous bone, the GraftNet XL device is ideal for any spinal fusion procedure.

GraftNet™ XL Bone Collection Device

The Angel cPRP and bone marrow processing system uses a proprietary platelet sensor and 1-button automation to deliver customized platelet-rich plasma (PRP) concentrate from bone marrow aspirate (BMA). Bone marrow is a rich source of platelets and nucleated progenitor cells. The Angel device is the only one to provide PRP concentrate from BMA with adjustable cellular levels.

Arthrex Angel® cPRP & Bone Marrow Processing System

Vet Systems - Orthobiologics

The Angel® system offers customized PRP formulations from whole blood or bone marrow aspirate. The Angel system’s revolutionary flexibility offers fully adjustable white blood cell content, platelet concentration and volumes with 1-button automation. Innovative design simplifies the setup procedure and offers the capability of processing flexible blood volumes. The adaptive spin technology ensures optimal platelet recovery. The advanced 3-sensor technology separates PRP, PPP and RBCs into separate sterile compartments.

The Angel® System Animation

Introducing the Arthrex Angel system, the only device that offers customized PRP formulations from whole blood or bone marrow aspirate. The angels revolutionary flexibility offers fully adjustable white blood cell content, platelet concentration, and volumes with one button automation. Innovative design simplifies the setup procedure and offers the capability of processing flexible blood volumes 40 to 180ml in a single pass. Simple touch screen menus and pre-set protocols allow for one button automation. The adaptive spin technology utilized by the Angel system ensures optimal platelet recovery. Advanced 3D sensor technology separates PRP, PGP, and RBCs into separate sterile compartments using cell specific wavelengths of light for consistent PRP output. The Arthrex Angel system. Revolutionary flexibility. Custom tailored PRP solutions.

The Arthrex Angel System™ and MAGELLAN® Autologous Platelet Separator System are two systems that create platelet rich plasma from a whole blood sample. The following study compared the minimized red blood cell setting of the Magellan (Min RBC) to the 2% hematocrit setting of the Angel, and standard Magellan to the 7% hematocrit setting of the Angel®.

Angel® vs Magellan®: A Comparative Study on Platelet Concentration and Activation

Cardiothoracic Surgery

Comparison of Angel® System and ART PRP and BMC Systems: Cellular Concentration

Bone Marrow Aspirate Processing Systems: A Comparison Study

Angel® cPRP and Bone Marrow Processing System

Agulha para entrega de enxerto fenestrada

The Vortex™ threaded recovery needle is ideal for maximizing the concentration of osteoprogenitor cells harvested during bone marrow aspiration.1 The unique designs of the threaded tip and vent holes allow the user to easily and accurately reposition the tip of the needle within the bone for optimal aspiration volume.
Patent pending
Reference
1. McLain RF, Boehm CA, Rufo-Smith C, Muschler GF. Transpedicular aspiration of osteoprogenitor cells from the vertebral body: progenitor cell concentrations affected by serial aspiration. Spine J. 2009;9(12):995-100

Vortex™ Threaded Bone Marrow Recovery Needle

The Vortex™ threaded recovery needle is ideal for recovering bone marrow aspirate from various parts of the body including, but not limited to, the vertebral body, anterior superior iliac spine (ASIS), posterior superior iliac spine (PSIS), distal femur, and calcaneus. The Vortex threaded recovery needle was developed in conjunction with Michael Gallizzi, MD.

Vortex™ Threaded Needle

The Arthrex Vortex needle is uniquely designed with a threaded tip that allows for precise depth and directional control of the bone marrow aspiration. The needle is offered in two sizes, eight gauge and 13 gauge, to accommodate a wide variety of anatomical approaches. Each rotation of the handle corresponds to movement at the tip of the needle, allowing the user to maximize the number of osteoprogenitor cells aspirated while minimizing the amount of whole blood. The Vortex needle can be used to aspirate bone marrow from a variety of locations, including, but not limited to the vertebral body, the posterior superior iliac spine, and the anterior superior iliac spine. To aspirate from the vertebral body via a posterior approach, insert the Vortex needle through the pedicle until the tip of the needle is in the anterior one third of the vertebral body. The use of a c-arm is recommended to verify correct depth and location. It is recommended that the needle be inserted into the bone using either a twisting motion from the hand, or a tapping action with a mallet. Through the use of a power drill connected to the needle using the power adapter, or through any combination of the three to maximize bone marrow recovery, a bi particular approach to the vertebral body can be used. After the needle has been inserted, the stylet is removed and the vacuum lock syringe is connected to the handle. Once the vacuum syringe has been attached, the plunger is pulled back and rotated in a counterclockwise motion to lock into place and start the vacuum. After the vacuum in the syringe has been set, bone marrow will be aspirated from the vertebral body through the tip and the vent holes of the needle. Monitor the Monitor the syringe for aspiration volume and rotate the handle counterclockwise, alternating between half turns and one and a half turns after every two cc's of aspiration. This will allow the needle to aspirate bone marrow from different depths within the bone, thus maximizing the amount of osteoprogenitor cells recovered and minimizing the amount of whole blood. The surgeon may also choose a needle with a closed tip, which aspirates BMA only from the vent holes on the side of the needle. This allows aspiration of BMA from a wider circumference around the needle, as the handle of the needle continues to be rotated in a counterclockwise manner. The depth of the needle will continue to decrease, allowing the needle to aspirate bone marrow from different depths within the bone, thus maximizing the amount of osteoprogenitor cells aspirated while minimizing the amount of whole blood obtained. Studies have shown that bone marrow aspirated from the vertebral body has a higher concentration of osteoprogenitor cells than bone marrow aspirated from other parts of the body. For the anterior superior iliac spine or ASIS. Approach a target three centimeters superior to the Assis should be used to avoid damage to the lateral femoral cutaneous nerve. To aspirate from the Assis. Insert the Vortex needle until the tip of the needle is at the appropriate depth into the ileum, as determined by the patient's anatomy. A c-arm should also be used to verify correct depth and location. It is recommended that the needle be inserted into the bone using either a twisting motion from the hand, tapping action with a mallet through the use of a power drill connected to the needle, using a power adapter, or through any combination of the three. After the needle has been inserted, the stylet is removed and the vacuum lock syringe is connected to the handle. The plunger is pulled back and rotated in a counterclockwise motion to lock into place, and start the vacuum to begin the aspiration. Shin bone marrow will be aspirated from the ileum through the tip and the vent holes of the needle. Monitor the syringe for aspiration volume and rotate the needle handle counterclockwise, alternating between half turns and one and a half turns every two cc's of aspiration. This will allow the needle to aspirate bone marrow from different depths within the bone, thus maximizing the amount of osteoprogenitor cells recovered and minimizing the amount of whole blood obtained. For the posterior superior iliac spine or Sis, a target area of approximately 2.5cm around the saw should be used to minimize damage to the cluneal nerves. To aspirate from the Sis, insert the Vortex needle until the tip of the needle is at the appropriate depth into the ileum, as determined by the patient's anatomy. A c-arm should also be used to verify correct depth and location. It is recommended that the needle be inserted into the bone using either a either a twisting motion from the hand, tapping action with a mallet through the use of a power drill connected to the needle, using a power adapter, or through any combination of the three. After the needle has been inserted, the stylet is removed and the vacuum lock syringe is connected to the handle. The plunger is pulled back and rotated in a counterclockwise motion to lock into place, and start the vacuum to begin the aspiration. Bone marrow will be aspirated from the ileum through the tip and the vent holes of the needle. Monitor the syringe for aspiration volume and rotate the needle handle counterclockwise, alternating between half and one and a half turns after every two ccs of aspiration. This will allow the needle to aspirate bone marrow from different depths within the bone, thus maximizing the amount of osteoprogenitor cells recovered and minimize the amount of whole blood obtained.

Arthrex Angel® cPRP and Bone Marrow Processing System With Vortex™ Threaded Bone Marrow Recovery Needle

Vortex™ Threaded Bone Marrow Recovery Needle Kit

Bone Marrow Aspiration Scientific Update

Spine Vortex™ Threaded Recovery Needles

8G Closed Tip Aspiration Kit With Angel cPRP System and ACD-A

8G Open Tip Aspiration Kit With Angel cPRP System and ACD-A

13G Closed Tip Aspiration Kit With Angel cPRP System and ACD-A

13G Open Tip Aspiration Kit With Angel cPRP System and ACD-A

The Arthrex ACP double-syringe system is used to facilitate the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. There has been increased interest in autologous blood products for use in a number of orthopedic therapies.

Arthrex ACP® Double-Syringe System - Autologous Conditioned Plasma

The Arthrex ACP® double-syringe system provides rapid and efficient concentration of platelets and growth factors from platelet-rich plasma (PRP) for use at the patient’s point of care. Its unique double-syringe design allows for safe and convenient handling of the biologic treatment.

Arthrex ACP® Double-Syringe System

A Patient’s Guide to Platelet-Rich Plasma With the Arthrex ACP® Double-Syringe System

Comparison of the Arthrex ACP® Double-Syringe System and RegenKit® PRP (Regen Lab)

Plasma-Based Autologous Blood Systems: Arthrex ACP® , MTF Cascade® , and Orthovita®  CellPaker®  and Vitagel™ Systems

In Vitro Effects of Autologous Conditioned Plasma (ACP)

Arthrex ACP® Double-Syringe System

The Arthrex ACP double-syringe system is used to facilitate the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient’s point of care.

The ACP Max™ system allows for collection of 30 mL, 60 mL, or 90 mL of whole blood for the preparation of platelet-rich plasma (PRP). Using a double-spin regimen, this buffy–coat-based system creates a PRP solution depleted of red blood cells and granulocytes, including neutrophils.1 Additional whole blood in the ACP Max PRP system encourages a more concentrated PRP solution and has the capability to create platelet concentrations up to 11 times higher than whole blood alone.1
 
Reference
1. Arthrex, Inc. Data on file (APT-5535). Naples, FL; 2022.

The ACP Max™ system provides efficient concentration of platelets and growth factors from platelet-rich plasma (PRP) for use at the patient’s point of care. Expanding on the previous generation of PRP devices, the ACP Max system allows for a larger blood draw and provides increased platelet concentration using a unique double-syringe, double-spin design.&nbsp;

ACP Max™ Platelet-Rich Plasma System

ACP Max™ System: Cellular Characterization and PRP Comparisons

Maximize Your Natural Healing Potential With the ACP Max™ Platelet-Rich Plasma (PRP) System 

Michael R. Baria, MD, MBA (Columbus, OH), provides an overview of the technique for the ACP Max™ platelet-rich plasma system.

ACP Max™ Platelet-Rich Plasma System Technique Overview

Hello, I'm Doctor Michael Berry, and I'm a sports medicine physician in Columbus, Ohio. And I'm excited to walk you through the ACP max system. Acp max is an expansion of the tried and true ACP system, allowing us to process a larger volume, concentrating a higher number of platelets while still producing a neutrophil reduced PRP. The ACP max system maximizes platelet concentration by using a dual spin process, accessing the buffy coat in the second spin. The ACP max system has two sterile package trays. The first tray contains the ACP max and ACP devices and two syringes for Pip extraction. The second tray contains all the necessary components for a blood draw. You have the option of drawing 30, 60, or 90 MLS. In this demonstration, we will be using 60 MLS of blood with anticoagulant. The volume of anticoagulant is dependent on the volume of blood drawn in a 1 to 7 ratio. With the blood draw completed. We'll remove the ACP max syringe from the tray. We'll prime the syringe by expressing air out of the of the system, and then cap the syringe with the red cap in the tray. The blood can be introduced from the top of the valve or the bottom, using a female to female connector. We'll remove the syringe guide and then slowly begin filling the ACP max system with our blood. The ACP max system uses a dual spin process, and in the first spin, we'll centrifuge ACP max syringe at 3200 rpms. The time on the first spin is variable depending on the volume. For the 60m volume, we'll spend for six minutes. We've prepared an appropriately measured counterweight at this stage. We'll place the ACP max syringe and the counterweight across from each other and spin. In this first spin, we're separating out the platelet poor plasma and creating a buffy coat layer. The platelet poor plasma rises to the top of the density gradient, while the buffy coat is concentrated between the plasma and red blood cell layers. At this point, we're ready to remove the PGP layer and extract the buffy coat. We'll thread our syringe guide back on. And withdraw the PGP layer, stopping two lines short of the red blood cell layer. Next, we'll attach the ACP syringe included in the kit and fill the syringe completely to 15 mls. The syringe will then be capped. And gently inverted to mix the solution. Now we'll spin for 1500 rpms for five minutes. This is consistent regardless of the initial blood draw volume. By stopping two tick marks short of the RBC layer, we ensure that we don't pull the buffy coat with the PB draw when we attach the ACP syringe. We draw the entire buffy coat layer, allowing us to resuspend the platelets in this second spin. We'll carefully place this on a flat surface and then use the internal syringe to pull the PRP. Stopping short of the RBC layer. Through this process, the ACP max system can deliver a highly concentrated PRP up to 12 times over baseline platelet concentration, devoid of neutrophils.

Thoracic Orthobiologics

AlloSync™ Bone Grafting Solutions

ArthroCell™ Viable Bone

BoneSync™ Putty and Strips

BoneSync™ BioActive Synthetic Bone Void Filler

GraftNet™ XL Bone Collection Device

Angel^® cPRP and Bone Marrow Processing System

Spine Vortex™ Threaded Recovery Needles

Arthrex ACP^® Double-Syringe System

ACP Max™ PRP System