In Europe, the interspinous process decompression devices market has been increasing over the last years
but it is estimated to grow at a much lower rate than previously expected. With a compound annual growth rate of 1.2%, this is low compared to the nonfusion market as a whole which is growing on average at 10%.
A form of dynamic stabilization – interspinous process decompression device procedures were the most commonly performed nonfusion surgery in Europe in 2009, accounting for nearly 40% of all spinal nonfusion procedures. Rapid adoption in the past was due in large part to the ease-of-use of the devices, resulting in surgeons implanting them for the treatment of broad indications. Surgeon use of these devices for inappropriate indications, however, resulted in many cases of device failure, which then led to a high volume of revision surgeries. As a result, reimbursement approvals for these devices are becoming stricter and are only granted when used in appropriate indications. Slowing in the number interspinous process decompression device procedures will result in decreased surgeon uptake of popular interspinous process decompression devices, including Medtronic Spinal & Biologic’s X-STOP and DIAM, Paradigm Spine’s coflex and Zimmer Spine’s Wallis.
“Surgeons are losing their initial enthusiasm about the technology, which is attributed to doubts about how effective interspinous process decompression devices are in treating pathological conditions of the spine,” says Andrew Lee, Analyst at MRG. “Payors in the UK and Italy are placing pressure on hospitals to reduce the use of interspinous process decompression devices by narrowing the indications for which the devices are reimbursed. Furthermore, poor clinical results in the medical literature will continue to curb the appeal of these devices to many surgeons in the future”.
In the US, the Interspinous fixation devices are intended to be used as an adjunct to interbody fusion. For example, the indication for use of the coflex-F implant “is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies – with up to Grade 1 spondylolisthesis.” Use of an interspinous fixation device for a stand-alone procedure would be considered off-label.Contemporary models of interspinous fixation devices have evolved from spinous process wiring with bone blocks and early device designs (e.g., Wilson plate, Meurig-Williams system, Daab plate). The newer devices range from paired plates with teeth to U-shaped devices with wings that are attached to the spinous process. They are intended to be an alternative to pedicle screw and rod constructs to aid in the stabilization of the spine with interbody fusion. Interspinous fixation devices are placed under direct visualization, while screw and rod systems may be placed either under direct visualization or percutaneously. Use of an interspinous fixation device in combination with a unilateral pedicle screw system has also been proposed. Interspinous fixation devices are not intended for stand-alone use. Interspinous fixation (fusion) devices contrast with interspinous distraction devices (spacers), which are used alone for decompression and are typically not fixed to the spinous process (see policy Related Policies). In addition, whereas interspinous distraction devices may use dynamic stabilization, interspinous fixation devices are rigid. However, the fixation devices might also be used to distract the spinous processes and decrease lordosis. Thus, the fixation devices might be used off-label without interbody fusion as decompression (distraction) devices in patients with spinal stenosis. If fixation devices are used alone as a spacer, there is a risk of spinous process fracture.
For use in combination with fusion, it is proposed that interspinous fixation systems are less invasive and present fewer risks than pedicle or facet screws. However, while biomechanical studies indicate that interspinous fixation devices may be similar to pedicle screw-rod constructs in limiting the range of flexion-extension, they may be less effective than bilateral pedicle screw-rod fixation for limiting axial rotation and lateral bending. There is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the interspinous device. There is also a potential for spinous process fracture. Given these uncertainties, studies are needed that compare health outcomes between interspinous fixation devices and pedicle screw-rod fixation.
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The following interspinous fixation devices have received CLEARANCE to market by the U.S. Food and Drug Administration (FDA). This may not be an exhaustive list.
The AILERON Expandable Posterior Fusion System responds to the patient’s and surgeon’s need for a simple, reliable, and less invasive system with minimal exposure and dissection. The in-situ expandable core offers patient matched expansion ensuring an ideal fit for every patient anatomy and pathology.
- In-situ expandable core provides a custom fit for every patient
- Bullet tip simplifies insertion
- Multiple implant lengths accommodate a variety of patient anatomies
- Aggressive fixation spikes allow for increased stability and security
- Less invasive approach results in minimal tissue disruption and trauma
- Bullet tip simplifies insertion
- Unique core design maximizes graft containment volume
- Aggressive fixation spikes increase stability and security
implant.Aspen is used as an adjunct to interbody fusion and/or posterior fusion with decompression in treatment from T1-S1. It provides an alternative to more conventional means of fixation such as pedicle screws or anterior plates. Aspen is delivered through a minimal midline incision which aids in quicker patient recovery and return to normal activity.
- Alternative to dynamic interspinous spacers for the treatment of spinal stenosis
- Alternative to conventional means of fixation to achieve fusion
- Proprietary spiked-plate design provides reliable bone fixation under both static and fatigue testing
- Serves to support the formation of fusion and decompression by fixation, load sharing and interspinous process spacing, while renewing anatomic alignment and decompressing spinal elements
- Minimal midline incision for quick patient recover and return to normal activity
- Offset shape to accommodate multilevel placement with a wide range of sizes for patient variations
- Bone graft enclosure facilitates load sharing, decompression and placement of bone graft
- Thoracic, Lumbar and Sacral (T1-S1)
The Axle Interspinous Fusion System of X-spine Systems, Inc., is an internal fixation device for spinal surgery. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patients.
The device may consist of titanium alloy (per ASTM F136), or both titanium alloy and polyetheretherketone (PEEK) (per ASTM F2026). All implants are intended for single use only and should not be reused under any circumstances.
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment
to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
BacFuse® (Pioneer Surgical)
The Pioneer BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1).It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis trauma (i.e., fracture or dislocation) and/or tumor.
restore sagittal alignment and facilitate a reliable interbody fusion. The device’s large contact area provides a strong anchor point from which to apply compression and offers optimal stability during the fusion process. The system is easy to use and the quick procedure offers minimal exposure, dissection, muscle trauma, and blood loss as well as protection of neural structures.
Key Features & Benefits
- Telescoping plates provide the ability to compress or distract spinous processes.
- Large bone contact area provides a strong anchor point to facilitate a reliable fusion.
- Large bone graft window allows placement of bone graft for fusion.
- Preassembled device minimizes operative time.
- Multiple implant sizes and implant angulation capability provide excellent fit and optimal fixation.
The BridgePoint Spinous Process Fixation System is intended for spinous process fixation T1-S1 for the following indications: • Degenerative Disc Disease (DDD)
Coflex-F® (Paradigm Spine)
confirmed by history and radiographic studies with up to Grade I spondylolisthesis. The minimally invasive system is designed to allow for a low-profile, tissue-friendly, anatomical fit. Please see Instructions for Use for complete list of warnings, precautions and contraindications.
- Interlaminar positioning
- Secure anchorage through rivet fixation
- Large contact area for optimized stress distribution
- Five anatomical sizes
- Color-coded instrumentation
- Titanium alloy that is biocompatible
- Reduced Iatrogenic Trauma
- Less muscle trauma and blood loss
- Smaller skin incision
- Reduced Surgical Risks
- Excellent safety profile
- Protection of neural structures
- Reduced Cost
- Shorter operating time
- Faster patient rehabilitation
- Ease of Use
- Simple surgical technique
- Intuitive instrumentation
Inspan™ (Spine Frontier)
instruments. The plates are offered in five hub diameters (8mm to 16mm in 2mm increments). The
device height (measured from the base of the central hub to the top of the wing) is fixed across all configurations at 18.85mm. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively.
Set screws are pre-installed in each side of the assembly and both are used to secure the assembly in its
final compressed and implanted state. A torque limiting driver is provided to ensure the appropriate screw
torque is applied.
- Trauma (fracture or dislocation)
- Degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies)
- Titanium implants provide superior strength and fixation
- Low profile design minimizes the implant footprint within the patient
- Cylindrical hub provide spinous process distraction
- Dual interlocking hub with dual set screws provides an exceptionally rigid design
- Compatible with the FacetFuse MIS Screw System
- Spikes are staggered to prevent fracture and provide optimal fixation
- Adapts to the anatomy of T1 through S1
- Easy to insert dual locking hub design
- Design optimized for the LES approach.Less Exposure Surgery, is the philosophy of achieving optimum surgical exposure while maximally preserving the anatomy and lessening the exposure to radiation and damaging effects of surgical techniques. It optimizes surgical access, useof radiation, muscle dissection, anatomy removal, and implant selection into one pivotalfocus: less exposure with optimal visualization.
fixation of the thoracic, lumbar and sacral spine while awaiting bony fusion to take place. PrimaLOK™SP is a bilateral locking plate system which attaches to the posterior non-cervical spine at the spinous processes. It is available in various heights and widths to accommodate differing anatomic requirements. The PrimaLOK™SP Instrument set includes a retractor, sizers, inserter, lock ring compressor and removal tool to facilitate the placement of the device. The PrimaLOK™SP is intended to be used to provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar and/or sacral spine.
The PrimaLOK™SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOK™SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.
The CD Horizon Spire Spinal System can provide surgeons with an easy and rapid insertion without fluoroscopy. Its use can potentially minimize soft tissue disruption. CD Horizon Spire may be used as supplemental fixation with CD Horizon products when surgeons perform a MAST(TM) Transforaminal Lumbar Interbody Fusion (TLIF). The CD Horizon Spire Spinal System may also reduce procedural costs and shorten the length of time a patient spends in an operating room.
- Optimal Fit: SP-Fix® implant assemblies are customized before implantation, allowing optimal positioning of the plates for secure and reliable fixation. PEEK Barrels can be sized independently of the plates to add distraction where necessary.
- Zero-Step Locking: With its ratchet design, SP-Fix® automatically locks during compression, eliminating extra tightening steps, and reducing complexity.
- Absolute Control: SP-Fix® instruments maintain control of the implant, allowing for precise implant delivery.
Romeo2 PAD (SpineArt)
- CENTRAL PEEK CAGE:The central PEEK cage includes a graft window and is designed to promote the fusion process.
- POLYAXIAL PLATE;The plate has 30° of polyaxiality (15° in each direction) and is designed to adapt well to the different varieties of the patient anatomy.
- ONE STEP LOCKING MECHANISM:The easy one step locking mechanism allows the surgeon to squeeze, fix and lock the implant at the same time.
- 360° FUSION WITH JULIET® CAGES:The combination of the ROMEO®2 PAD and the JULIET® cages through a small incision and a unilateral approach completes the 360° fusion.
- COMPACT SET:Only one box of intuitive instruments
ZIP™ - MIS Interspinous Fusion System (Aurora Spine)
|The Zip.Aurora Spine|
Aurora Spine is proud to announce the impending launch of the ZIPTM MIS Interspinous Fusion System. The ZIP is a minimally invasive spinal fixation device for spinal fusion and was developed as an alternative to pedicle screw fixation.
The ZIP was designed for the stabilization during T1-S1 lumbar fusion procedures specifically for the treatment of degenerative disc disease, spinal tumors and trauma.
The ZIP has a unique, ONE-step zip locking mechanism that eliminates the use of a setscrew and allows the pedicles to remain intact. The ZIP is available in various sizes to accommodate different sized anatomy.Not cleared by the FDA…yet
STAND-ALONE INTERSPINOUS DEVICES
The APERIUS™ PercLID™ System was the first Percutaneous stand-alone Lumbar Interspinous
Decompression System. It is indicated for patients suffering from degenerative lumbar spinal stenosis with neurogenic intermittent claudication between the interspinous process spaces of L1 to L5.
BacJac (Pioneer Surgical)
Coflex (Paradigm Spine)
Based on the FDA clinical study, (Coflex is approved by FDA) when compared to the standard of care (fusion surgery), patients receiving the coflex® device experienced:
- Shorter operating time and hospital stay
- Quicker recovery
- Faster and sustained pain relief
- Greater mobility at treatment level
- Natural movement at adjacent levels
- DIAM.Surgical Technique.Direct Link.PDF
- DIAM.Surgical Technique.PDF
- Youtube.Diam Surgical Technique.Animation
Potential benefits of the DIAM™ Spinal Stabilization System:
- Provides an alternative to spinal fusion
- Fits between the interspinous processes and functions as a shock absorber that reduces loads on the surrounding vertebrae
- Only requires a small incision to implant, which can reduce scarring, shorten surgery time and decrease recovery time.
Gelfix (Replication Medical, Inc)
Key Features & Benefits
- Preserves motion
- Limits extension and prevents nerve compression
- Preserves anatomical structures
- Minimally invasive
- Implant Features and Benefits
- PEEK material
- Self-distracting helical tip
- Five sizes to accommodate different patient anatomies
- Tantalum markers for visualization
(LSS). This device offers the advantages of a reduced incision size, minimized muscle trauma and preservation of the supraspinous ligament.
InSWing offers a less invasive surgical approach, requires minimal or local anesthesia, reduces blood loss, and resultsin shorter rehabilitation then alternative surgical procedures.
Placed between the spinous processes of the lumbar spine using a unique unilateral approach, innovative InSWing is secured through the deployment of a proprietary double-wing structure resulting in the widening of the spinal canal and decompression of the symptomatic level. Additional stability can be obtained with the application of a polyester band.
• Less invasive
• Easy implantation
• Opens to relieve stenosis
• Precise fit
The silicone core has an innovative shape : the anterior part is designed to perfectly suit the interlaminar space, and is sized in five different heights; the posterior part, with a triangular shape, has a linear cavity allowing deformation in extension.On the anterior part, the textile is covered with a layer of silicone to avoid fibrosis in the yellow ligament area.Surgery can be performed by mini-invasive monolateral approach, using the device alone, or following a midline bi-lateral technique if combined with its artificial ligament in case of weakness of the supraspinous ligament.
- Full motion preservation, both in flexion and extension
- Support on the laminae allowing intervertebral decompression
- Lordosis restitution, respecting the instantaneous axis of rotation
- Constrainted elastic absorption
ISS is an interspinous device made in titanium alloy, without pedicular screws or ligament, allowing
• Maintains and protects the intervertebral disc height
• Put the disc at rest
• Treats the disc pain
• Redistributes discal loads
• Available in 5 sizes (8, 10, 12, 14 and 16mm)
Indications for use:
• Lumbar Pain due to Hyper Mobility of Collapsed Disc(Max 1/3 Disc Height)
• Dynamic Narrow Lumbar Spine Canal
• Instability Post Fenestration
• Slow Degenerative Spondylolisthesis (grade 1)
• Posterior Joint Syndrome
• Post Discectomy Instability
- Youtube.Vertiflex Superion Product Animation
- Vertiflex.Superion.Surgical Technique.PDF
• One piece, expandable implant
• Minimally invasive midline approach
• Motion preserving
• Tissue sparing and fully reversible
The Superion ISS system is designed to deliver the implant through a single small incision in the patient's back, utilizing VertiFlex’ proprietary interspinous access platform. The procedure can be performed under local anesthesia on an outpatient basis and closed with a single suture. Once in place, it may reduce pressure on the nerves that cause pain and allow the return to a more active lifestyle.Superion has been CE marked since 2007 and is currently an investigational device in the U.S. Enrollment completed in the Superion pivotal IDE trial with 470 patients in December, 2011. It has been implanted in over 2000 patients worldwide.
To date, VertiFlex has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.
- Preserve Anatomy, Keep Options Open:Resulting in the preservation of anatomy, Wallis System keeps all options open in terms of potential future operations for low back disorders.
- Design and Materials:The design and materials minimize need for bony resection and permit an even distribution of stresses on the bone: Anatomical design: grooves that fit the physiological shape of the spinous processes, optimization of the surface of contact: flat polyester band for improved stress pattern on the bone, elasticity: spacer and clips made of PEEK for mechanical properties close to those of bone and openings in the spacer for maximum reduction of the implant rigidity.
- Flexion and Extension:The Wallis Implant limits the amplitude of movement in flexion and extension1Reduction of 35% of the flexion-extension mobility when implanted in a damaged segment (study performed on 6 cadaveric specimens). The Wallis Implant increases the rigidity of the segment in flexion and extension Inflexion and extension the implantation of a Wallis System increases the rigidity by a factor of 1.9 and 1.5 times, respectively.
- Intradiscal Pressure:The Wallis Implant reduces the intradiscal pressure.In an in vitro Finite Element model, the Wallis Implant reduces the intradiscal stresses in a damaged disc both in flexion and extension. The Wallis Implant does not alter the mechanical behavior of the adjacent segment.
Wellex (Eden Spine)
A WELLEX™ surgery is minimally invasive, with reduced operative time and no removal of bony and soft tissue. In addition, implants are customized pre-operatively to adapt to patient morphology and provide the best possible results. Biomechanically, the Wellex maintains flexion, axial rotation and lateral bending but more importantly, it is not an extension blocker! It controls extension dynamically, positively impacting the neutral zone and reducing disc and facet loading. Multi–level implantations are possible.
- Restores and maintains intervertebral dimensions
- Reduces abnormal posterior loading
- Increases the segmental stiffness
- Restores facet congruence
- Maintain physiologic kinematics of the FSU
- Allows movement in flexion, extension, lateral bending
- Limits motion, especially in the neutral zone
- Fills the gap between conservative less effective care & riskier fusion
By enlarging the space between the bones in your back, the X-Stop Spacer reduces pressure on the spinal nerves, thereby alleviating the symptoms of lumbar spinal stenosis, including:
Leg pain, cramping,Numbness or tingling in the lower back, buttocks and legs
The X-Stop Spacer has undergone clinical studies and is the only interspinous spacer approved in the United States to treat the symptoms of LSS. The X-Stop Spacer offers superior relief of LSS symptoms and overall treatment success when compared with non-surgical treatment.
The X-Stop Spacer is designed to remain safely and permanently in place without attaching screws or hardware to the bone or ligaments in your back. In addition, the bone and tissue removal typically associated with traditional back surgery is not necessary with this device, thus, the natural anatomy of the spine is preserved.