Features

Spinal Tap

By Michael Barbella, Managing Editor | September 20, 2016

Minimally invasive procedures, biologics, and patient-centric business models are driving growth in the global spine market.

It was truly an historic moment.

After gently guiding a two-foot putt for par into the bottom of the hole at No. 10, Tiger Woods dropped his putter and raised his arms over his head. His overjoyed parents—mother, Kultida and father, Earl—simultaneously embraced him, their shoulders shaking with sobs.

Woods’ reaction that day was a mixture of relief, satisfaction, and near disbelief in achieving a come-from-behind victory over University of Florida sophomore Steve Scott in the 1996 U.S. Amateur tournament. Augmenting the magnitude of Woods’ win—his third consecutive Amateur title, an unprecedented feat at the time—was his substandard performance for much of the 38-hole competition: Woods trailed Scott through 33 holes, missed multiple burdie putts, and lost his rhythm in the morning, winning just seven of 25 par-5 holes.

Yet Woods fought his way back from five down, regaining his rhythm and confidence through birdies on the third and fourth holes and remaining under par on the 463-yard ninth hole. He answered Scott’s birdie on the 10th with an eagle at the 11th, and followed his opponent’s 15-foot birdie at the 14th with an eight-foot birdie at the 15th. At the tournament’s final hole, Scott’s ball slid about seven feet past the cup. His next putt lipped out.

Woods lightly tapped his ball into the hole, sealing his place in amateur golf history.

“An occasion for the ages,” declared the Aug. 26 1996, edition of the Los Angeles Times.

“In a comeback as dramatic as any in the annals of golf...Tiger Woods, 20, roared into history yesterday,” read a New York Times article from the same day.

Indeed, few would object to such characterizations of Woods’ win 20 years ago. Even Scott was humbled by his challenger’s triumph, telling the Los Angeles Times,  “He caught on fire and did his famous comeback. You know Tiger. He does his thing. He just turns on the afterburners and leaves you in the dust.”

Those afterburners, however, were a significant concern to pro golfer Johnny Miller, the lead golf analyst for NBC Sports. Before Woods played his first event as a professional, Miller expressed his concern with the young prodigy’s swing, predicting it could seriously damage his spine.

“The only thing that bothers me is that Tiger at 20 already has swing-related injuries and signs of a bad back even though he works out and is in buff condition,” Miller wrote in a 1996 Golf World column published shortly after the U.S. Amateur tournament. “The combination of being wiry, strong, and blazing fast puts a lot of stress on his spine. He weighs about 155 pounds and can carry the ball almost twice that far in yards. That’s almost unheard of. If you take a 350 Chevy smallblock engine and it puts out 400 horsepower, no problem. But Tiger puts out about 650. When you do that in a car, it’s easy to throw a rod.”

Woods has thrown numerous rods over the course of his career, although none have impacted his game as much as the spinal injuries he’s suffered over the last six years. An inflamed facet joint in his neck forced Woods to withdraw from the 2010 Players Championship during the final round, and two lower back surgeries (microdiscectomies) have prevented the golf legend from playing competitively for more than a year. Woods’ absence from the 2016 PGA Championship is the 10th major tournament he’s missed since winning the U.S. Open in 2008, according to Golf Digest.

A microdiscectomy or microdecompression spine surgery involves removing a tiny piece of bone over the nerve root, or disc material, to relieve pain caused by a pinched nerve. During the procedure, doctors lift the back muscles off the arch of the spine and remove a membrane over the nerve roots, visible through special glasses. The nerve root is then moved over, giving the surgeon the chance to remove the disc material.

Woods is among the estimated 250,000-300,000 Americans annually who seek relief of pinched nerve pain through a discectomy. Technological advances over the last several decades have enabled surgeons to perform these procedures with minimal trauma to the muscles and surrounding spinal tissue, ensuring less blood loss, quicker recovery times, and shorter hospital stays compared with traditional (open) methods.

The minimally invasive (MIS) and traditional spinal implant markets are expected to reach a combined market value of more than $9 billion by 2020, iData Research Inc. statistics indicate. “The major driving force behind growth in MIS interbody procedures is the perceived physiological benefit to the patient, including reduced trauma, shorter hospital stays, lower postoperative medication use, and earlier return to motion,” explained iData President/CEO Kamran Zamanian, Ph.D.

To further explore the potential of MIS spine technologies, as well as the possibilities in store for the global spine market, Orthopedic Design & Technology spoke with various manufacturing professionals and company executives over the last several weeks. Participants included:

Dean Poulos, sales and marketing manager for Gauthier Biomedical Inc., a Grafton, Wis.-based instrument manufacturer for spine, trauma, hip, shoulder, knee, ankle, and small bone surgical procedures.

Peter J. Randall, sales manager for Tracer Orthopedics/OrthoLynx, an Oakland, N.J.-based orthopedic product supplier offering a range of instruments including silicone handles, ratcheting and coupling systems, and torque limiting devices.

Jeffrey R. Schell, president and CEO of TranS1, a Denver, Colo.-based spinal device firm and developer of the minimally invasive AxiaLIF+ vertebral fusion product. The internal distraction rod in AxiaLIF+ allows surgeons to individualize distraction in situ based on each patient’s needs, according to the company.

James Schultz, executive vice president of ECA Medical Instruments, a designer and manufacturer of single-use torque-limiting surgical instruments, fixed drivers, and customized implant fixation kits to the medical device industry. The company is located in Thousand Oaks, Calif.

Michael Barbella: What trends are you seeing in the spine market? What factor(s) are driving these trends?
Dean Poulos:
Medical device OEMs are trying to shorten the time it takes to launch new surgical systems. It’s cliché but it’s certainly true that time is money and so customers are pushing hard to launch quickly and efficiently. This requires them to gather all the necessary field inputs, design and develop surgical techniques with state-of-the-art implants and instrumentation, and then bring to market these proprietary solutions all under the shortest of timelines. From developing safe and adequate testing protocols to preparing design history files and FDA submissions, Gauthier engineers assist customers to help shorten the time it takes to go market. We’re able to help customers achieve success through assisting them as they navigate through the instrument development process. As an engineering resource as well as a manufacturer, we have extensive experience with DFM [design for manufacturability] as well as cleaning and sterilization validations, so we know what works and what doesn’t. When a customer comes to us early in the design phase, we’re able to help them not only find ways to improve instruments and how they’re made, but also ensure they are going to get processed effectively and efficiently in the field. So whether it’s delivering instruments that are able to be cleaned and sterilized better, or simply having test samples at the ready so that nothing is holding up the show, we are constantly trying to help our customers streamline the launch cycle. It’s important to not only ensure they are getting safe and dependable instrumentation, but also make sure schedules and launch dates are hit.

I think it’s a trend that has been building momentum for years. It’s based on the narrowing of profit margins caused by healthcare pricing pressures and it has really put the burden on new product development teams to do things not only better but quicker and often with less resources. So they are not only working harder to ensure supplier readiness, they are also teaming up with partners who have the experience in doing things better, faster, cheaper. As a valued partner we are able to not only have designers and engineers at the ready but also provide better ways of doing things because we have a rich history in instrumentation design. From DFM exercises that help lower the costs of instruments to offering design input that helps our customer with their cleaning and validation process, we’re constantly looking at ways to not only maximize productivity in the OR but also upstream and downstream as well. We’re doing this by finding what efficiencies our customers can take advantage of and then offering better ways to design instruments to realize those advantages. One example of this is that we’re designing instruments that can be reprocessed quicker and easier. At the end of the day, time is money.

Peter J. Randall: 1. A definite push towards MIS (minimally invasive surgery) and less invasive procedures. Studies are showing the short-term benefits associated with smaller incisions and muscle/tissue sparing procedures. Patients are returning to daily routines and work in a shorter period of time with less tissue scaring.  However, MIS procedures require more complex and costly instrumentation to manufacture.

2. More complex instrumentation means there are fewer instruments in tray sets. The drive towards more functional instrumentation combines the functionality of several older instruments into one. This means suppliers of today must invest in newer technology and equipment to stay competitive. 

3. DLIF (Direct Lateral Interbody Fusion) — Here a patient is placed on their side and the spine is accessed this way instead of the conventional TLIF (Transforaminal Lumbar Interbody Fusion) or PLIF (Posterior Lumbar Interbody Fusion) type surgeries, where the patient is placed faced down and the spine is accessed through the back (posterior side), or ALIF (Anterior Lumbar Interbody Fusion), where surgery is performed through the front of the patient. The reason this is gaining popularity is due to the ability to protect the psoas muscle.  This muscle connects the lumber vertebrae all the way to the femur and is a key muscle to maintaining spinal stability.  

4. The larger OEMs have been buying up manufacturing companies and bringing key services inside. Many have found it very costly to develop and implement vendor quality systems and controls, so we see consolidations of vendors and processes. Not only does this help them manage costs better, it gives them more control over lead times of key product(s). 

5. DMLS (Direct Metal Laser Sintering)—The equipment and processes have been coming down in manufacturing costs. A number of spinal implant companies have developed, tested, and have received FDA approvals for both cervical and lumbar cages to be manufactured by this process and implanted in patients. These same companies can now build intricate implantable cages very quickly with surfaces designed to promote faster boney in-growth. This creates quicker spinal stability and healing for positive patient outcomes.

Trauma-Taming Tech
Since debuting in hospitals during the 1980s, minimally invasive spine surgery has undergone rapid advances in equipment, techniques, and safety. The procedure was developed by surgeons to access the spinal column with minimal disruption to the muscles and surrounding tissue, enabling quicker recovery times, smaller incisions, and significantly less postoperative pain.

The number of these types of procedures is expected to grow substantially over the next decade, driven mostly by the planet’s aging population, an increasing number of insured patients, and new product launches. Decision Resources Group estimates the U.S. minimally invasive spine technology market to grow roughly 6 percent annually through 2023, much faster than the traditional open spinal implant sector. “There is significant innovation happening in complementary markets to minimally invasive spine technologies that could have a positive impact in the long term,” Decision Resources Group Senior Analyst Rene Azeez noted. “For example, there is growing interest in robotic guidance, which can increase the accuracy of minimally invasive spine procedures. Companies are also launching bone graft substitutes designed specifically for minimally invasive procedures. In particular, companies are focusing on the large minimally invasive spinal fusion space and the fast-growing facet fixation market.”

Many of the market’s major players have developed minimally invasive spinal surgery technology. Some of the options available to clinicians include:

The METRx MicroDiscectomy System developed by Medtronic plc allows surgeons to precisely locate, view, and remove herniated spinal discs through tunnels created by tubes that split back muscle, much like a sewing needle splits the weave of fabric, along natural divisions. Muscle fiber is separated rather than cut, enabling doctors to access the spine through a posterior approach. The METRx system separates muscle through specially designed metal tubes (dilators) that progressively increase in diameter and are inserted sequentially (small to large).

The ARIA Spinal System, part of Stryker Corp.’s LITe (Less Invasive Technologies) platform, is designed to provide access and treatment to the lumbar spine through a lateral or anterolateral approach, including anterior retroperitoneal exposure via a small incision. This surgical technique allows the placement of an AVS ARIA PEEK (polyetheretherketone) Spacer across the disc space while avoiding the anterior vessels and posterior neural and bony elements.

Globus Medical’s REVOLVE system features highly refined instruments for streamlining each step of lumbar pedicle screw delivery. The posterior stabilization system’s integrated rod reduction and non-threaded locking cap implant enables surgeons to treat tumor, trauma, and spinal deformities using one instrument with the cap pre-loaded.

The iFuse Implant System from SI-BONE Inc. has been used in more than 20,000 procedures to treat certain sacroiliac joint disorders. The triangular implants provide 31 times the rotational resistance of a screw; the devices are composed of titanium and are coated with a porous, titanium plasma spray that helps decrease implant motion and allow for biological fixation to support long-term fusion. The company claims iFuse is the only commercially available SI joint fusion device with published clinical evidence, including three large multicenter prospective studies, that demonstrate safety and effectiveness.   
  
Earlier this year, Premia Spine launched its ProMIS fixation system with Advanced MIS screw placement, a device that offers surgeons a choice of four screw placement techniques in one instrument kit: a k-wireless method, a direct skin-to-screw placement, a tap-Shidi approach, and a traditional reusable Jamshidi technique. ProMIS also offers a pedicle screw (supplied in an individual sterile pack) that has a patented surface treatment designed to promote bony ingrowth. The proprietary implant surface technology consists of a roughened topography that creates an optimal screw-bone response and promotes bone growth into the micro-crevices of the screw surface. A peer-reviewed study published in the Journal of Bone and Joint Surgery demonstrated significant resistance to pullout forces with the Premia Spine pedicle screw. In the study, 2.3 times the force was required to remove the screw with the surface treatment vs. a non-treated screw.

The EVEREST Minimally Invasive Spinal System from K2M Inc. features a cannulated top-loading polyaxial pedicle screw system that can accommodate titanium and cobalt-chromium rods of two different diameters. The lead thread pattern allows for faster insertion and demonstrates increased pullout strength, while the mixed metal tulip minimizes head splay and improves mechanical performance. — M.B.
Jeffrey R. Schell: Minimally-invasive techniques continue to rapidly progress and advance. These techniques enable efficiency for surgeons and favorable outcomes for patients. Increasingly, the reduced cost of such techniques relative to open techniques that require longer hospital stays seems to play a larger role in the adoption of MIS techniques, especially at outpatient surgery centers. Patients generally enjoy a reduced recovery time following MIS procedures, and recent innovations including AxiaLIF+ have demonstrated a surgical success rate similar or better to rates associated with open procedures. Another trend we continue to observe and combat is the reduction in the pace of innovation. We regularly hear from our spine surgeon stakeholders that they are frustrated with lack of ability to develop new treatments and work with companies to bring them to market. Part of this may stem from the increased merger activity—larger companies are looking for completed products instead of developing new products that cannibalize their existing portfolios. TranS1’s approach—that of placing surgeons in a position to innovate—is different because as a smaller company we can be more nimble.

We also have taken great care to focus on developing a strong in-house R&D team and partnerships with groups like Rocky Mountain Patent and R&D support groups—those who can advance new concepts. TranS1 has focused on bucking the trend of slowing innovation in spine.

James Schultz: The trend is toward improving outcomes, lowering costs, outpatient surgeries, minimally invasive surgeries and robotics. The market is also consolidating with recent acquisitions by the major OEMs to secure advanced technology and in other cases add market share. This will continue for next few years such that four or five OEM implant firms remain who can provide full service implant solutions from cervical to sacral joint repair, scoliosis correction and a wide range of cages or interbodies, pedicle, polyaxial and facet screws, plates, and fusion devices. Patients want to avoid spine surgery where possible and neurostimulation devices for pain relief will continue to grow in demand as CMS and private payers are questioning fusion outcomes and are more circumspect about approving reimbursements.  The market is getting quite competitive and hence OEM margins will be challenged.

Barbella: Please discuss the potential for growth in the spine market over the next five to 10 years. What is driving this growth?
Poulos:
Certainly the market has cooled down from the double digit years of the past. Though things have steadily moved at a more modest pace, growth is achievable. One market driver that sticks out to me is that advancements are improving patient outcomes. With improved patient outcomes, a wider population of people are being exposed the possibility of finding a fix for what ails them, whether it’s an uncle who had a good experience with his new hip or a neighbor who just had a major quality of life improvement after a spinal fusion. We live in an era where advances in medicine are sometimes unbelievable and through information exchanges like orthopedic seminars, congresses and symposiums, the wealth of knowledge sharing is incredible too. I believe that through steady advancements growth is not only achievable but inevitable.

Randall: Biologics will continue to be a driving force. The key is to focus on using a patient’s own cell structure to stop and heal diseases and spinal instability. This spares the patient from costly surgeries that cannot be reversed and any related trade-offs that may accompany any surgery. Autografts (using a patient’s own cell/tissue) minimizes rejection of foreign substances and promotes better healing outcomes over the long term.   

Single-use products provide a simple solution to highly expensive inventories of bulky instrumentation, reducing the number and weight of each instrument tray. It also benefits the patient with a clean and sterile product which may lead to lower surgical infection rates.  

Simply put, less invasive procedures means less pain and we can return to a more functional daily routine quicker than traditional procedures that can be very invasive and extensive.

Schell: Spine is moving into an outpatient environment. With fewer days in the hospital comes lower costs and better patient satisfaction. Surgeons can often safely perform minimally invasive techniques in smaller hospitals or ambulatory surgery centers. Less invasive, yet highly effective technologies such as AxiaLIF+ enable surgeons to operate such that minimal tissue trauma is incurred during the surgical approach, dramatically reducing recovery time and need for inpatient stay. Surgeons have increasingly accepted the benefits to patients associated with less traumatic surgical approaches, leading to a higher share of surgeons performing MIS procedures. The growth opportunities in the spinal market will relate to the ambulatory and outpatient model as a result of disruptive innovation in surgical techniques that have happened, especially in the past 10 years.

Schultz: There are about 2 million spine implants per year worldwide. The majority of these are for single- or two-level fusion for trauma or degeneration repair. Market growth is forecasted to be in range of 4 percent to 6 percent year over year for fusion procedures. In the U.S. there are about 700,000 fusion implants per year with over 57 percent for thoracolumbar procedures and 43 percent for cervical. New markets such as China and India are growth opportunities as price points drop and surgeon skill levels increase. Global human weight gain in general from wheat-based diets and trauma has increased lumbar surgeries to repair discs and spine degeneration. 

Barbella: Please discuss the biggest challenges your company is facing right now in the spine sector and how the firm is overcoming these challenges.
Poulos:
The growth in the spine sector has been modest, so we’re seeing many of the spine players trying to out maneuverer or outflank each other with enhanced quality, innovation and speed. We’re constantly being asked to help them in that initiative one way or another. The OEMs are seeking to increase market share and we believe we have the resources and means to help our customers increase their market share.

Randall: Tracer Orthopedics/OrthoLynx is a manufacturer and distributor of hand instrumentation. From our perspective, we believe the market is flooded with competition. Our challenge is in creating an image that distinguishes us from the rest of the pack so to speak with better customer focus and service, and a wider range of product offerings.

Schell: A challenge that every spinal device company currently faces is the tendency for insurance companies to create barriers, sometimes unnecessarily, for patients and surgeons seeking surgical intervention to address spinal pathology. We have observed an increasing number of cases where a patient has been suffering for several months and needs spine surgery to address debilitating pain, but cannot receive care because of the burdensome and overbearing requirements some insurance companies have created prior to receiving needed surgical care. TranS1 is not immune to this challenge. We have worked hand-in-hand with spine societies to make care available to patients who need it most. 

Also, consolidation in the industry has slowed the pace of innovation. Many surgeon needs remain unmet. TranS1 has a unique advantage in that we are product development company. As a product development company we remain nimble; we can rapidly develop technologies to respond to surgeon needs and cost constraints. We value our opportunity to work with surgeons to drive innovation that dramatically improves patient outcomes. By working closely with our partners at Rocky Mountain Patent and The Quandary Group, we can efficiently develop new solutions to pressing surgical needs while simultaneously protecting surgeon innovations with patents on new, disruptive technologies, quickly reacting to market opportunities and industry-specific needs.

Schultz: At ECA Medical Instruments, we are working with the major OEMs to develop optimized single-use torque limiters and procedural kits for the full range of implants. Many of our precision disposable torque-limiters are in the market today providing surgeons and patients with accurate fixation of implants across cervical and thoracolumbar applications. They are replacing reusable instruments, which are hard to clean, out of calibration or at risk due to excessive wear and tear. Probably the most recognizable spine kit we produce today is the single- and two-level fusion instrument kit we developed with Intelligent Implant Systems (Charlotte, NC). This kit has seen scores of successful implants and outcomes for patients and is the pioneering disposable kit in the marketplace. In the near future you will see more disposable instrument spine kits on the market including both posterior and anterior cervical fusion kits that hold torque limiters, fixed drivers, drill guides, sounders/depth gauges and other instruments needed to complete the surgery. The cost savings to OEMs, hospitals, and outpatient surgical centers is significant and a sterile packed instrument set helps eliminate risk of surgical site infection and assures exact fixation of spine plates, screws and fasteners.

Barbella: What specific areas of spine are companies investing R&D time and dollars in (surgical, minimally invasive implants, spinal fusion, artificial discs, etc.)? Why are companies investing in these areas?
Randall:
Tracer Orthopedics/OrthoLynx is focusing on two key areas: a) more complex and unique instrumentation, and b) complimentary “single-use” devices that fit with our current hand instrumentation offered. These will help set us apart from just being a contract medical device manufacturer and supplier that looks like all the rest. Marketing and purchasing people are much better informed today than they ever were in the past. By providing better access to information, we can build a stronger brand awareness of our company.

Schell: Certainly minimally invasive techniques will continue to be developed. With AxiaLIF+ as our main product, TranS1 continues to lead the development of the minimally invasive pre-sacral approach for fusion at L5-S1. The pre-sacral approach enables surgeons to maintain the annulus intact and avoid the damage that the anterior, transforaminal, posterior and lateral approaches cause to the bony, muscular, nervous and ligamentous tissues surrounding the spine. We also see enhanced opportunities for innovation in approaches at the higher levels, including tweaks to direct and oblique lateral approaches to spinal fusion. Moving away from the status quo technologies at these areas, which often result in unnecessary damage to the surrounding structures like the psoas muscle and nerve clusters, will enable surgeons to achieve much less damage to the patient during spinal fusion procedures.

Schultz: Market demand for single- and two-level plating is steady. Fusion represents over 80 percent of the marketplace. Many markets are underserved because of price points or lack of surgical expertise. The big OEMs are investing in training surgeons in these countries and providing essentially the same implants that are available today in the U.S. and Europe under different brand names so they can reduce the sales price and attract a larger customer base. ECA is helping these implant firms by providing disposable instrument sets that are pristine and always ready for surgery and in perfect torque. OEMs are trying to increase sales and market share in all countries. They need cost and packaging differentiators that separate them from their competitors. In this area we provide significant, measurable and sustained value. 

Barbella: How has your company been able to succeed in the competitive and volatile spine care market over the past decade or so?
Poulos: Simple, we’ve succeeding by listening to our customers and offering them solutions that help drive their business forward.

Randall: Tracer Orthopedics/OrthoLynx is very successful because of one key ingredient, total customer satisfaction. By remaining flexible to our customer’s needs and anticipating their direction, be continue to grow consistently with them. We are an extension of their core needs. So if we can help them to be successful, then so are we.  

Schell: Simply put, our product offering offers advantages that our competitors cannot. TranS1's AxiaLIF+ technology uses our patented pre-sacral approach to accomplish fusion at the L5-S1 junction, and as the company celebrates its ten year anniversary, there is still nothing on the market that is:
•   as minimally invasive
•   as cost effective with the estimated $3,500 savings that AxiaLIF+ provides, or
•   less traumatic to surrounding tissues 
Many patients who have undergone the AxiaLIF+ procedure report life-changing, long-lasting results including advanced physical activity, diminished or eliminated back pain and other benefits. The procedure was also recently described in the 2016 version Benzel’s Spine Surgery, 4e (Steinmetz & Benzel-ISBN: 978-0-323-40030-5), a go-to resource for spine surgeons around the world. TranS1 has also gained significant recognition and support from surgeons across the U.S.

Barbella: Where do you see the spine market heading in the next 5-10 years, and how has your company positioned itself for growth? 
Poulos: We see tremendous growth opportunities ahead. We’ve got a good recipe for success and we’re confident that we can continue to keep doing what has gotten us here today. We’ve had tremendous growth over the past 16 years and with a constant eye towards what’s important to our customer, both today and in the future, we feel we have what it takes to continue to be a leader in the instrumentation industry. 

Randall: Tracer Orthopedics/OrthoLynx builds solid customer focused relationships strengthened with integrity and honesty. We don’t promise what we can’t deliver. We build on the core strengths of the people and resources we have. 

Schell: The market will continue to grow where minimally invasive technologies advance. Widely considered as the most minimally invasive technology for fusion of L5-S1, AxiaLIF+ provides TranS1 with a key advantage in this market segment. AxiaLIF+ often is the only option for surgeons seeking a minimally invasive solution to fuse L5-S1 without destroying the bony supportive structure of the spine (as often occurs during TLIF, which typically requires the removal of a facet). The approach trajectory of AxiaLIF+ for L5-S1 fusion also removes some of the risks associated with the anterior approach, which requires careful navigation around major vascular structures. I have also noticed more surgeons shying away from ALIF procedures in outpatient environments in general. With AxiaLIF+ as its core product offering, TranS1 is very well positioned to succeed in a marketplace shifting toward MIS procedures.

Schultz: Disposable instruments and procedural kits for specific implant procedures are the way of the future. The cost savings, potential to increase sales, maintain or increase margins and tap into new customers in new markets offers compelling business models. We are poised to support all the spine OEMs as they move to capture more business in U.S. and Europe and globally.


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