Early-onset scoliosis (EOS) is defined as a spinal deformity occurring before ten years of age.Untreated EOS or early spinal fusion resulting in a short spine is associated with increased mortality and cardiopulmonary compromise.Scoliosis is a curvature of the spine to either side, which is more than 10 degrees 1 , it can also mean an increased kyphosis, which is an over-curvature of the upper portion of the back 2 . 2-3% of the U.S. population has a form of scoliosis. Early onset scoliosis (EOS) is a scoliosis identified or diagnosed by a doctor in patients under the age of 10.There are various devices available to treat EOS, depending on the severity of the curvature and the age of the child.
Here are some of the commonly used EOS devices:
- Bracing: Bracing is the most common non-surgical treatment for EOS. Braces can be custom-made for each patient and are worn for 20-23 hours a day to slow or stop the progression of the curve. There are different types of braces available, including Boston Brace, Providence Brace, and Milwaukee Brace.
- Growth rods: Growth rods are surgically implanted devices that help straighten the spine as the child grows. The rods are attached to the spine and adjusted every six months to accommodate growth.
- Vertical expandable prosthetic titanium rib (VEPTR): VEPTR is a device used for children with severe EOS. It is a titanium rib that is surgically implanted and helps to straighten the spine while allowing for growth of the chest cavity and lungs.
- Mehta casting: Mehta casting is a non-surgical treatment for EOS that involves applying a cast to the child’s torso to straighten the spine. The cast is changed every few months to accommodate growth.
- Halo gravity traction: Halo gravity traction is a non-surgical treatment that involves attaching a halo to the child’s head and using weights to gradually straighten the spine. This treatment is usually used in conjunction with bracing.
It is important to note that the treatment of EOS depends on the severity of the condition and the age of the child. A doctor or spine specialist will recommend the best course of treatment based on the individual needs of each patient.
Patients with more severe curves may require surgical correction of their scoliosis. There are several surgical options that allow the spine to grow while controlling the curve; these options include:Tension-based device (Tether or Staples) Magnetically Controlled Growing Rods (MAGEC™), Vertical Expandable Prosthetic Titanium Rib (VEPTR®), Growth Guided Devices (Shilla® or Luque Trolley) ,Traditional Growing Rods (TGR),or a spinal fusion.
Which are the most Advanced Products for Early Onset Scoliosis (EOS Product Section)?
What is Vertebral Body Tethering? Vertebral body tethering has been proposed as an alternative to bracing in the treatment of scoliosis in children and adolescents. Vertebral body tethering is a technique in which bone screws are anchored to the front of each vertebral bone in the curved area of the spinal column. A flexible cord, or tether, is attached to the screws and tensioned to attain the desired degree of spine straightening.
Some of the benefits to vertebral body tethering include allowing for continued growth and mobility, faster recovery time, spinal motion sparing, and less placement of hardware. However, concerns for vertebral body tethering include the possibility of overcorrection of the curve, potential disc degeneration within the instrumented spine, potential for fixation failure or cord breakage, and infection.
1.-The Tether™ – Vertebral Body Tethering System | ZimVie
Zimmer Biomet’s anterior vertebral body tethering (AVBT) solution, The Tether, uses a strong, flexible cord made of SULENE® PET (polyethylene-terephthalate) , rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow. This growth modulation approach now offers select, well-indicated patients an option to achieve a straighter spine, without the limitations of spinal fusion. Additionally, unlike fusion metallic rods, The Tether is positioned utilizing an endoscopic minimally invasive approach through a few small openings between the ribs.
STATUS: The FDA granted the approval of The Tether – Vertebral Body Tethering System to ZimVie Spine on August, 2019.
Advantages:
- Less invasive
- Less surgical hardware
- Curve reduction dependent on curve flexibility
- Less blood loss and risk of infection
- Can be used pre-skeletal maturity
- Spinal Motion sparing
- Long-term complications unknown
2.-REFLECT™ | Globus Medical
REFLECT™ is an anterior scoliosis correction system that is used to apply fixation on the convexity of the scoliotic vertebrae with a flexible cord to limit growth on the convex side and allow unilateral growth on the concave side.
STATUS: (May 15, 2023) — Globus Medical, Inc. (NYSE: GMED), announces the REFLECT™ Scoliosis Correction System has been granted approval from the US Food and Drug Administration (FDA), as the company’s first humanitarian device.
Advantages:
- Minimally Invasive: Multi-functional instruments facilitate REFLECT™ cord insertion and tensioning using a mini-open anterior or posterior approach. REFLECT™ is designed to be implanted through a thorascopic approach to help minimize tissue disruption and scar tissue formation.
- Optimized Implant Offering: Low profile screws with a non-threaded locking mechanism and diameter-specific staples, used in conjunction with the REFLECT™ cord, create an optimized construct for spinal alignment to maintain stability while allowing growth in skeletally immature patients.
- Intraoperative Deformity Correction: Tensioning instruments allow for controlled curve correction with exceptional ease of use.
3.- MIScoli™ | Spinologics
The MIScoli™ system is one of a few VBT devices that are under investigation, or limited market release, in many countries. Various medical device developers have committed to developing VBT solutions to serve an unmet need in the scoliosis surgical treatment market.
The MIScoli System was honored to have been designated as a Breakthrough Device by the US Food & Drug Administration (FDA).
VBT is a promising and lesser invasive alternative to spine fusion, today’s standard of care when adolescents need a surgical intervention to correct a curvature of the spine. Patients, and their parents, are looking for treatment options that are less traumatic than fusion, which is associated with long in hospital and at-home recovery times, growth and mobility restrictions, longer term pain and narcotics requirements and significant surgical scars.
4.- Auctus Dynamic Tethering System | Auctus Surgical
Auctus Surgical, a company devoted to non-fusion options for scoliosis patients, is developing a one-of-a-kind vertebral body tethering (VBT) system to treat pediatric scoliosis with a non-fusion, dynamic approach. The company is announcing the recent Breakthrough Device Designation by the FDA, a recognition that the Auctus dynamic vertebral body tethering system is unique and will meet a clear clinical need.
Benefits:
- Dynamic tension
- Complete non-surgical adjustment
- Most effective in making gradual non-surgical adjustments over time
- Prevents over-correction and can act as internal brace
5.- MAGEC® | NUVASIVE
MAGECTM is a magnetically controlled growing rod that after the first surgery can be lengthened with an external set of strong magnets without surgery. The system has been approved by the FDA and examined in both animals and humans and shown to be safe and effective.NuVasive Inc. purchased Ellipse Technologies Inc. in 2016. Ellipse was the developer and marketer of a novel platform of magnetically adjustable implant systems based on its MAGnetic External Control, or MAGEC®, technology.
STATUS: FDA Approved
MAGEC technology implants are adjustable at the time of implantation and are distracted non−invasively over the course of treatment to accommodate the changing clinical needs of patients as they heal, grow or age. It enables physicians to customize therapy for patients in a non-invasive manner, reducing the need for further repeat surgical procedures, and providing meaningful improvements in patient clinical outcomes and quality of life while generating cost savings to the healthcare system.
MAGEC is the only noninvasive solution for growth modulation in pediatric spinal deformity currently cleared by the FDA. The system’s proprietary magnetic technology allows distraction of a growing rod construct in a clinical setting, helping reduce the number of surgeries required to treat patients with early onset scoliosis (EOS).
6.-FLYTE | AMB SURGICAL II
Comprising a team of elite engineers and orthopedic industry experts, AMB Surgical is devoted to the development and commercialization of its FLYTE™ smart automated growing rod technology which holds promise to reduce anxiety and trauma from juvenile and adolescent surgeries. Device is not cleared by the FDA yet
FLYTE is the next generation growing rod implant for the treatment of complex pediatric spine deformities. FLYTE is a sophisticated electro-mechanical, software activated device to provide real-time biomechanical feedback to guide treatment allowing surgeons to perform accurate, non-surgical skeletal adjustments. The results in are expected to reduce costs, surgical risks and improved patient outcomes.
The key to FLYTE is the innovative combination of miniature gearing, power, sensors and wireless communication technology located inside the device. FLYTE is controlled remotely by a software application that programs the device, makes surgeon-programmed adjustments, records and monitors real-time biomechanical information over the course of treatment. FLYTE has the promise to significantly reduce the number of surgeries and cost while improving patient outcomes.
7.-Spring Distraction System (SDSTM) | Cresco Spine
Cresco Spine, a new player in the spinal arena and a spin-off of the University Medical Center Utrecht (the Netherlands), today announced that it raised seed investments from InSpine and Utrecht Health Seed Fund (UHSF) to continue its development of their unique surgical spinal correction platform “Dynamic Implant SolutionsTM” (DISTM), initially focused on early onset scoliosis.
Within its “Dynamic Implant SolutionsTM“ platform, Cresco Spine is finalizing the Spring Distraction System (SDSTM) for market introduction. The SDSTM is a unique, spring based dynamic distraction system that works with standard of care posterior pedicle screw fixation. The system has the potential to guide the growth three-dimensionally without the need for invasive lengthening interventions. This will improve outcomes, whilst minimizing re-operations and surgical and anesthetic burden in this vulnerable patient group. Several follow-on opportunities for Cresco Spine’s technology have been identified and will be next in line within the DISTM platform.
8.- KYRA® Correction Cord System | Tria Spine
KYRA® Correction Cord System is a fixing system which includes various types and sizes of pedicle screws, cord and nut.KYRA® Correction Cord System is the medical device which treats scoliosis while a person is actively growing and uses their own growths to repair their curves.KYRA® Correction Cord System is a spine device which has been designed for the treatment of idiopathic scoliosis.The KYRA® Correction Cord System is different than typical scoliosis surgery which is called “spine fusion”, which involves placing rigid metal bars on both sides of the spine to correct undesirable curves.
KYRA® Correction Cord System uses a strong, flexible cable to apply pulls outside a scoliosis curve to straighten of the spine instead of metal rods. The system uses the growth process to permanently straighten the spine.Fixation systems are indicated for skeletally immature patients who require surgical treatment to achieve and maintain the correction of progressive idiopathic scoliosis. It is not suitable for use by adults.
INDICATIONS
KYRA® Correction Cord System which it is with a large Cobb angle of 30 to 65 degrees, as determined by radiographic imaging, the bony structure is dimensionally sufficient for screw fixation, it is indicated for skeletally immature patients who require surgical treatment to achieve and maintain progressive idiopathic scoliosis.It is not suitable for use by adults.
Benefits:
- Suitable for MIS
- Cord: Polyethylene-Terephthalate
- Titanium:(Ti6Al4V ELI) Alloy
- Cannulated Body Design
- Better Stability
- Biocompatibility
- Reliable Solution for Idiopathic Scoliosis
9.- Braive | Medtronic
In September, 2021 Medtronic announced that it has enrolled its first patient and completed the first surgical procedure in its BRAIVE™ IDE study, which will evaluate the safety and effectiveness of the Braive™ growth modulation system for treatment of progressive juvenile (JIS) or adolescent (AIS) idiopathic scoliosis. The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
The Braive growth modulation system uses a braid secured to the spine with screws to slow growth on the curved side of the spine, while allowing growth to continue on the other side. The BRAIVE IDE study will evaluate whether the system is safe and effective in correcting the spine’s curve in patients with juvenile or adolescent idiopathic scoliosis. The prospective, multi-center study will enroll patients in the United States, Canada, and the United Kingdom.
The device is Medtronic’s latest innovation in the pediatric spine category, and the study’s initiation reaffirms the company’s commitment to continued innovation for pediatric patients.
About 4% of children globally have scoliosis, making it one of the most common pediatric orthopedic deformities.1 It occurs when the vertebrae twist or rotate, causing the spine to curve into a “C” or “S” shape, rather than a straight line. It typically occurs in children and impacts girls more often than boys. Standard treatment options may include braces or spinal fusion surgery. According to the National Scoliosis Foundation, an estimated 30,000 children a year receive a brace to treat their condition, while 38,000 patients are treated with spinal fusion.2 While successful in correcting the spine’s curve, spinal fusion causes vertebrae to fuse together into a single bone, which stops growth in that area of the spine.
10.- CurvRITE | SpineGuide Technologies
CurvRITE, a 3D multi-segment growth guidance rod, to treat children suffering from scoliosis especially early onset scoliosis (EOS) and Early Adolescent Scoliosis (AIS).
More than 30000 patients accept scoliosis correction surgeries each year in the US alone. Such surgeries are highly invasive and require multiple efforts to keep the spinal growth. There is a highly unmet clinical need for treatment that provides both good correction and spine growth with fewer surgeries and less trauma.
Our device CurvRITE, invented by an orthopedic surgeon, is a game changing implant system that corrects the curved spine in just a single surgery and allows spine to grow noninvasively under the guidance of our device.
First in Human Trial:
- 5 enrollments started in Q2 2021
- 2 cases for EOS and 3 cases for AIS
- 83% improvement in correction comparing to other leading products
- 96% Improvement inthoracic spine height after initial surgery comparing to traditional growing rod
- 90% less trauma comparing to low-implant density product
How Does CurvRITE Work:
Step 1: CurvRITE Initial Surgical Implantation
CurvRITE corrects curvature during initial surgical implantation through 3D correction
Step 2: Spine grows along CurvRITE’s Guidance Rod
CurvRITE enables spine growth noninvasively through socket structures with an anti-rotation mechanism. Spine grows along CurvRITE’s guidance rod.
CurvRITE Advantages
- Significant correction improvement: Correction efficacy in one surgery is better than multiple surgeries with existing devices.
- No adjustment surgeries/treatments needed: Potentially completely eliminate the most invasive and riskiest spinal surgery – the final correction and fusion surgery
1 minute introduction video from the founder Dr. Li.
11.- MARVEL™ Growing Rod System | Globus Medical
The MARVEL™ Growing Rod System is designed for patients under the age of 10 with early onset scoliosis to obtain and maintain correction while allowing continued growth through minimally invasive distraction. The expansion mechanism provides a large distraction range and tactile feedback during expansion.
Features and Benefits:
- Reliable Expansion: Geared mechanism provides powerful distraction, direct tactile feedback, and automatic locking
- Efficient Lengthening: Novel expansion mechanism designed to accommodate growth patterns and minimize implant wear
- Minimally Invasive: Expansion requires only a small incision for driver access, minimizing soft tissue disruption
12.- Luque Trolley | Depuy Synthes
The Modern Luque Trolley technique was implemented in 2011, updating the technique invented by Eduardo Luque forty years back. The Modern Luque Trolley is performed by fixing one pair of rods proximally and the other pair of rods distally with the help of apical gliding anchors. The proximal and distal rods grow with the spine while the apical gliding anchored still.
13.-NEMOST | EUROS
The NEMOST implant is a sterile, single-use device, intended to be surgically implanted via a posterior approach.It is a growth implant intended for pediatric use in children with RISSER 0 and as first intention surgery.The desired effect is a regular lengthening of the device to obtain a gradual correction of the spinal deformity over time while allowing the continued growth of the child.The NEMOST implant should make it possible to reduce or even eliminate iterative lengthening surgeries of conventional growth constructs.
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According to EFORT, EOS surgery can also be performed with:
- Traditional ‘growing’ rods (TGR) requiring repeated surgical distractions typically performed every six months,
- With Shilla (Medtronic) and other growth guidance systems:
- With a vertical expandable prosthetic titanium rib (VEPTR),
SOURCE: EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.170051