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Global Regenerative Trade

MAGELLAN®

SPINAL SURGERY

WHAT IS REGENERATIVE MEDICINE?

Regenerative Medicine encompasses many medical fields – Orthopedics and Spine Surgery, Sports Medicine, Gynecology, Urology, Oncology, Dermatology, Plastic surgery, Vascular Surgery, Cardiac surgery, etc.

Regenerative Medicine is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues. Regenerative medicine includes the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs. It uses autologous blood, bone marrow or adipose components to stimulate the body’s own repair processes. A common source for regenerative cells and growth factors are bone marrow aspirate concentrate (BMAC), platelet rich plasma (obtained from one’s own blood) and adipose derived stem cells.

PATHOLOGY

Spinal Pathology can be anything from a degenerative spine or scoliosis to more acute complex trauma. There are many different levels of spinal pathology, along with many symptoms, ranging from tingling or numbness to acute pain. If you have endured any of these symptoms, and feel you have back pain that needs to be treated, it’s important to understand what you are up against along with your options. Here, we discuss common conditions, who it effects, and how it is treated.

HERNIATED DISC

The bones (vertebrae) that form the spine in the back are cushioned by discs. These discs are round, like small pillows, with a tough, outer layer (annulus) that surrounds the nucleus. Located between each of the vertebra in the spinal column, discs act as shock absorbers for the spinal bones.

A herniated disc (also called bulged, slipped or ruptured) is a fragment of the disc nucleus that is pushed out of the annulus, into the spinal canal through a tear or rupture in the annulus. Discs that become herniated usually are in an early stage of degeneration. The spinal canal has limited space, which is inadequate for the spinal nerve and the displaced herniated disc fragment. Due to this displacement, the disc presses on spinal nerves, often producing pain, which may be severe.

Herniated discs can occur in any part of the spine. Herniated discs are more common in the lower back (lumbar spine), but also occur in the neck (cervical spine). The area in which pain is experienced depends on what part of the spine is affected.

A single excessive strain or injury may cause a herniated disc. However, disc material degenerates naturally as one ages, and the ligaments that hold it in place begin to weaken. As this degeneration progresses, a relatively minor strain or twisting movement can cause a disc to rupture.

Certain individuals may be more vulnerable to disc problems and, as a result, may suffer herniated discs in several places along the spine. Research has shown that a predisposition for herniated discs may exist in families with several members affected.

Symptoms vary greatly, depending on the position of the herniated disc and the size of the herniation. If the herniated disc is not pressing on a nerve, the patient may experience a low backache or no pain at all. If it is pressing on a nerve, there may be pain, numbness or weakness in the area of the body to which the nerve travels. Typically, a herniated disc is preceded by an episode of low back pain or a long history of intermittent episodes of low back pain.

Lumbar spine (lower back): Sciatica/Radiculopathy frequently results from a herniated disc in the lower back. Pressure on one or several nerves that contribute to the sciatic nerve can cause pain, burning, tingling and numbness that radiates from the buttock into the leg and sometimes into the foot. Usually one side (left or right) is affected. This pain often is described as sharp and electric shock-like. It may be more severe with standing, walking or sitting. Straightening the leg on the affected side can often make the pain worse. Along with leg pain, one may experience low back pain; however, for acute sciatica the pain in the leg is often worse than the pain in the low back.

Cervical spine (neck): Cervical radiculopathy is the symptoms of nerve compression in the neck, which may include dull or sharp pain in the neck or between the shoulder blades, pain that radiates down the arm to the hand or fingers or numbness or tingling in the shoulder or arm. The pain may increase with certain positions or movements of the neck.

SPINAL CORD INJURY

spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in its function. Symptoms may include loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cord below the level of the injury. Injury can occur at any level of the spinal cord and can be complete injury, with a total loss of sensation and muscle function, or incomplete, meaning some nervous signals are able to travel past the injured area of the cord. Depending on the location and severity of damage, the symptoms vary, from numbness to paralysis to incontinence. Long term outcomes also ranges widely, from full recovery to permanent tetraplegia (also called quadriplegia) or paraplegia. Complications can include muscle atrophy, pressure sores, infections, and breathing problems.

In the majority of cases the damage results from physical trauma such as car accidents, gunshot wounds, falls, or sports injuries, but it can also result from nontraumatic causes such as infection, insufficient blood flow, and tumors. Just over half of injuries affect the cervical spine, while 15% occur in each of the thoracic spine, border between the thoracic and lumbar spine, and lumbar spine alone.Diagnosis is typically based on symptoms and medical imaging.

DISC PROTRUSION

disc protrusion is a disease condition which can occur in some vertebrates, including humans, in which the outermost layers of the anulus fibrosus of the intervertebral discs of the spine are intact, but bulge when one or more of the discs are under pressure.

Many disk abnormalities seen on MRI that are loosely referred to as “herniation” are actually just incidental findings. These may be unrelated to any symptoms and are just bulges of the anulus fibrosus. Jensen and colleagues, in an MRI study of the lumbar spine in 98 asymptomatic adults, found that in more than half, there was a symmetrical extension of a disc (or discs) beyond the margins of the interspace (bulging). In 27 percent, there was a focal or asymmetrical extension of the disc beyond the margin of the interspace (protrusion), and in only 1 percent was there more extreme extension of the disc (extrusion or sequestration). These findings emphasize the importance of using precise terms in describing the imaging abnormalities and evaluating them strictly in the context of the patient’s symptoms.

A disc protrusion may progress to a spinal disc herniation, a condition in which there is a tear in the anulus fibrosus.

PROCEDURES

SPINAL FUSION

Spinal fusion is a surgical procedure used to correct problems with the small bones in the spine (vertebrae). It is essentially a “welding” process. The basic idea is to fuse together two or more vertebrae so that they heal into a single, solid bone. This is done to eliminate painful motion or to restore stability to the spine.

Spine surgery is usually recommended only when your doctor can pinpoint the source of your pain. To do this, your doctor may use imaging tests, such as x-rays, computerized tomography (CT) scans, and magnetic resonance imaging (MRI) scans.

Spinal fusion may help relieve symptoms of many back problems, including:

  • Degenerative disk disease
  • Spondylolisthesis
  • Spinal stenosis
  • Scoliosis
  • Fractured vertebra
  • Infection
  • Herniated disk
  • Tumor

Description

Spinal fusion eliminates motion between vertebrae. It also prevents the stretching of nerves and surrounding ligaments and muscles. It is an option when motion is the source of pain, such as movement that occurs in a part of the spine that is arthritic or unstable due to injury, disease, or the normal aging process. The theory is if the painful vertebrae do not move, they should not hurt.

If you have leg pain or arm pain in addition to back pain, your surgeon may also perform a decompression (laminectomy). This procedure involves removing bone and diseased tissues that are putting pressure on spinal nerves.

Fusion will take away some spinal flexibility, but most spinal fusions involve only small segments of the spine and do not limit motion very much. The majority of patients will not notice a decrease in range of motion. Your surgeon will talk with you about whether your specific procedure may impact flexibility or range of motion in your spine.

SUPPORTING EVIDENCE

SPINAL DISC INJECTION

PUBLICATIONS

Haufe SMW and Mork AR. Intradiscal injection of hematopoietic stem cells in an attempt to rejuvenate the intervertebral discStem Cells Dev. 15:136-137. 2006.
 
Pettine KA, et al.  Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 monthsStem Cells. 33:146-156. 2015.
 
Tuakli-Worsonu YA, et al. Lumbar intradiskal platelet-rich plasma (PRP) injections: A prospective, double blind, randomized controlled study. PMR doi: 10.1016/j.pmrj. 2015.08.010, 2016.

SPINAL FUSION

PUBLICATIONS

Ajiboye, R.M., et al. Clinical and radiographic outcomes of concentrated bone marrow aspirate with allograft and demineralized bone matrix for posterolateral and interbody lumbar fusion in elderly patientsEur Spine J. 24: 2567. 2015. doi:10.1007/s00586-015-4117-5.
 
Gan Y, et al. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusionBiomaterials. (29): 3973-3982. 2008.
 
Hart R, et al. Allograft alone versus allograft with bone marrow concentrate for the healing of the instrumented posterolateral lumbar fusionSpine J. 14(7): 1318-1324. 2014.
 
Johnson, RG.  Bone marrow concentrate with allograft equivalent to autograft in lumbar fusionsSpine. 39(9): 695-700. 2014.
 
Vadala G, et al. Use of autologous bone cells concentrate enriched with platelet-rich fibrin on corticocancellous bone allograft for posterolateral multilevel cervical fusion.  J Tiss Eng Regen Med. 2: 515-520. 2008

VIDEOS

Vivostat Logo

THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.