Technology advances in spine surgery

Manufacturers, clinicians and others focusing on technology advancement in spine surgery are not developing radical innovations, but are making enough incremental improvements in a number of ways that result in growth in the industry.  Most improvements fall into a number of categories:

Screen Shot 2015-09-14 at 7.29.36 AMNew materials technologies: Historically, spinal fusion instrumentation was fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and fatigue resistance. However, one key drawback of these metallic implants is incompatibility with diagnostic imaging, including MRI and CT scans, which are crucial for visualizing changes to the spinal cord and vital soft tissue structures of the spine. To overcome these issues a variety of new materials such as biocompatible carbon fiber-reinforced (CFR) thermoplastic materials and implantable polyetheretherketone (PEEK) polymers were examined as an alternative to the traditional materials. In addition to biocompatibility, biostability and compatibility with diagnostic imaging, these advanced thermoplastic polymers provide a range of mechanical properties that are well suited to the demanding environment of spinal implants.

Implantable PEEK polymers are available today in an array of formulations, ranging from unfilled grades with varying molecular weight, to image-contrast and carbon fiber-reinforced grades. The first implantable unfilled PEEK polymer–PEEK-OPTIMA was pioneered in 1999 by United Kingdom-based Invibio Biomaterial Solutions. Introduced by Invibio in 2007 to provide controlled visibility through X-ray, CT and MRI technologies, image-contrast grades offer tailored opacity that allows for easier post-operative device placement verification by surgeons and clear assessment of the healing site. Also launched by Invibio in 2007, carbon fiber-reinforced (CFR) grades provide significantly increased strength and stiffness as well as a modulus similar to that of cortical bone.

The CD HORIZON LEGACY PEEK Rod from Medtronic Sofamor Danek and the EXPEDIUM™ PEEK Rod System from DePuy Spine, Inc., are examples, in which these polyetheretherketone (PEEK) polymers are radiolucent and have the ability to reduce scatter and artifact from CT and MRI images. [Picture source: MRI scan via Shutterstock]

Screen Shot 2015-09-14 at 7.24.36 AMComputer aided fixation of spinal implants: A number of proprietary techniques are being developed that provide computer or robotic alignment for the placement of spinal implants. Current research ensures that further developments will occur resulting in more extensive use of computer aided fixation. [Picture source: NIH]

 

percutaneous spineMinimally invasive spine surgery: Manufacturers have development technologies in percutaneous and endoscopic approaches to spine surgery that are having (and will continue to have) a significant impact on patients, clinical practice and the market for spine products.  It is producing all the expected benefits of less invasiveness — less traumatic surgery results in shorter recovery times and better outcomes and opens up spine surgery to more elderly, infirm and other patients for whom traditional spine surgery would be contraindicated. [Image: Handbook of Minimally Invasive and Percutaneous Spine Surgery; allamericanspeakers.com]

 

Screen Shot 2015-09-14 at 7.19.47 AMVariable axis screw systems: A variable axis screw system is a pedicular screw system that features a variable-axis head, which offers a ±25 degrees of angulation. The system also offers a pre-contoured rod. The contoured rod, along with the angulation available in the screw head, alleviates the need for rod contouring. The screw also features a pre-assembled head and double lead thread. The pre-assembled head reduces the steps required for construct assembly and the double lead thread increase the speed of screw insertion and construct assembly so that the overall operative time can be shortened. [Picture source: DePuy Synthes]

Products, technologies, markets, companies and opportunities in the spine surgery industry are the focus of the MedMarket Diligence Report #M540, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” The next five purchasers of this report (any option) will receive a 25% discount off the published price online by entering the coupon code “spinepricectomy”.

 

Global Market For Medical Device Technologies in Spine Surgery, 2014-2021

MedMarket Diligence is completing a global analysis of spine surgery technologies, scheduled for publication in August/September:

Global Market For Medical Device Technologies in Spine Surgery, 2014-2021:
Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” See link.

This report is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery.The report provides a current and forecast to 2021 by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade. The report profiles 75 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development.

See the full description and table of contents at Report #M540.

What is spine surgery?

What is spine surgery? Specifically it’s:

  • Anterior Lumbar Interbody Fusion (ALIF)
  • Anterior Cervical Corpectomy
  • Anterior Cervical Discectomy and Fusion (ACDF)
  • Axial Lumbar Interbody Fusion (AXiaLIF)
  • Cervical Laminaplasty
  • Cervical Posterior Foraminotomy
  • Direct Lateral Interbody Fusion (DLIF)
  • Discectomy
  • Endoscopic Surgery
  • eXtreme Lateral Interbody Fusion (XLIF)
  • Foraminotomy and Foraminectomy
  • Intradiscal Electrothermal Therapy (IDET)
  • Kyphoplasty
  • Laminectomy
  • Laminoplasty
  • Laminotomy
  • LASER Surgery
  • Microdiscectomy (Minimally Invasive Technique)
  • Oblique Lumbar Interbody Fusion (PLIF)
  • Posterior Lumbar Interbody Fusion (PLIF)
  • Scoliosis Correction
  • Spinal Decompression
  • Spinal Fusion
  • Spinal Instrumentation
  • Spinal Osteotomy
  • Thoracoscopic Release
  • Transforamenal Lumbar Interbody Fusion (TLIF)

These represent the range of options to address diseases and trauma of the spine. To varying degrees, these procedures can require multiple instruments and/or implants and other products, which encompass the following:

  • Cervical interbody cages or spacers
  • Anterior cervical plates
  • Artificial cervical discs
  • Thoracolumbar plate systems
  • Interbody fusion devices
  • Thoracolumbar screw/rod systems
  • Minimally invasive implants
  • Artificial disc replacement implants
  • Interspinous implants
  • Demineralized bone matrix
  • Synthetic bone graft substitutes

See pending Report #M540.

The Staying Power of Spine Surgery Markets

While medtech over the past five years has seen continued pressure on prices, increased oversight on physician-manufacturer relationships, reduced med/surg procedure volumes, continued regulatory challenges and the real or perceived negative impacts of the Affordable Care Act, the business of spine surgical technologies remains one of the most steadfast oases of innovation and price stability.

The continued growth of spine surgery owes itself to a number of key drivers:

  • The ageing population worldwide
  • Increasing incidence of obesity
  • A growing middle class in developing countries, with the ability to pay out of pocket for spine surgery
  • Improving worldwide economy
  • Technological device enhancements, leading to improved surgical results
  • Developments in minimally invasive spine surgery (MISS) devices driving a strong increase in MISS, with its numerous advantages
  • In the US, improvements in reimbursement as clinical trials demonstrate the efficacy of treatments using the devices
  • US healthcare reform leading to medical insurance coverage for more people, allowing those suffering from intractable back pain to receive surgical treatment

(The last, of course, is debatable, since medical device manufacturers are not yet convinced that a 3.2% excise tax is supported by the anticipated boost in patient population. The jury is still out on this and, in any case, prospects for the 3.2% tax being repealed are slim, despite repeated efforts.)

Consequently, the worldwide aggregate spine surgery market has a 2012 to 2020 compound growth rate of 7.7%, with individual segments within it growing at a low of 2.3% to a high of 35.0%.

It is also worth noting that we have identified seven (7) new medtech startups (McGinley Orthopaedic Innovations, KB Medical, Trice Orthopedics, Tyber Medical, Direct Spinal Therapeutics, NLT Spine, Osseus Fusion Systems) in spine surgery that have been founded in the past three years alone.

Below is illustrated the spine surgery markets in the Americas and Europe for 2012-2020.

Screen Shot 2014-05-28 at 10.33.52 AMScreen Shot 2014-05-28 at 10.34.10 AM

Source: MedMarket Diligence, LLC; Report #M520, “Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020”.

Pedicle Screw Fusion Faces Maturing Market… But Still Growing

For markets approaching a phase of maturity — facing the introduction of competing new technologies taking away market share — price reductions are an effort to counterbalance the forces for declining demand.  However, in the case of pedicle screw fusion systems in spine surgery, price pressures are acting independently of demand.  In essence, there is such demand for spine surgery treatments that, even in the face of new device treatments competitive with pedicle screw fusion, there is growth in procedure and unit volumes such that even a nominal -0.7% CAGR decrease in prices from 2011 to 2020 is associated with a 9% CAGR in the pedicle screw fusion systems market.  

In the "short" run (i.e., 5-10 years), this can be sustained, but demand for alternative spine surgery devices will continue to accelerate and prices for pedicle screw systems will be forced to drop more steeply in response.

Below is a graph of pedicle screw fusion system unit volumes against average selling price during the 2010 to 2020 forecast period.

Source: MedMarket Diligence Report #M520: Worldwide Spine Surgery 2010-2020.

 

Unit volume growth in pedicle screw systems in the face of declining prices and increasing markets for competitive technologies is testimony to the enormous demand for spine surgery solutions to chronic back pain and the other adverse sequellae of spine trauma and disease.

Spine Surgery Map

Spine surgery is a broad area of clinical practice encompassing treatments for many different conditions encompassing degenerative disc and other spinal diseases, congenital and adult spinal deformities, autoimmune diseases of the spine, and the many different conditions of spinal trauma.

Therefore, the range of approaches to addressing spine disease and trauma is equally broad.

Below is a rough outline of spine surgery treatments, drawn from our 2011 Worldwide Spine Surgery report:

Source: MedMarket Diligence Report #M520.

Spine surgery technologies: changes in market composition

 

Markets for products in spine surgery show a decline in spine fusion and total disc replacement, but an increase in intraspinous process spacers and nucleus replacement.  Although the exhibit below displays this only for Asia/Pacific markets, the trend is true globally.

asia-pacific-spine-fusion

Source:  Exhibit 3-107 is taken from MedMarket Diligence report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

 

Despite the recent challenge to vertebroplasty, indicating that its results are equivalent to controls, kyphoplasty offers a more progressive approach, via balloon expansion, to disc compression.

Minimally invasive spine surgery becoming technology-enabled

While patient concerns remain a significant driver in the development of minimally invasive techniques, technological advances in surgical instrumentation have transformed the theoretical to the practical. Advanced fluoroscopy, or x-ray imaging during surgery, has markedly improved the accuracy of incisions made and hardware placed. A variety of endoscopes, camera-tipped wands, can be inserted through small incisions and provide the surgeon with excellent visualization of the operative site. New surgical instruments were developed to work in tandem with endoscopes. The past several years have brought numerous innovations to spine surgery. These innovations include the development of imaging systems that interpret anatomical data for three-dimensional display; the use of lasers, ultrasonic frequencies, and high-pressure water jets remove tissue; and new monitoring devices that help the surgeon to optimally position instrumentation as well as to warn of potentially damaging neural contact during a procedure. Spine operations that lend themselves particularly well to minimally invasive approaches are intervertebral disc decompressions and discectomies. Progress has been made in adapting certain kinds of spinal fusion procedures to a minimally invasive approach, and certain forms of scoliosis of the thoracic spine have been treated with minimally invasive surgery.

mis-spine

Source:  MedMarket Diligence, LLC; Report #M510, "Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017."

MIS has many enthusiastic supporters. However, caution needs to be exercised, as even though a technique is less traumatic, if the rate of successful spinal fusion is much lower, then there is really not an advantage. Also, it has yet to be demonstrated that minimally invasive spine fusion systems actually cause better outcomes than some other surgical techniques used in the traditional open approach.

Increasingly, minimally invasive techniques are becoming the preferred method for autologous bone graft procedures. Traditional procedures involve the surgeon making a 3- to 5-inch incision to harvest bone from the patient’s hip area, and some studies have shown that complications arise in nearly a third (31%) of these patients. These studies also show that about 27% of patients still feel pain in the hip area up to two years after the surgery.
 

 

New Surgical Techniques Drive Market Opportunity for Advanced Surgical Closure and Securement

In cardiovascular and spine surgery, multi-billion dollar markets were created from entirely new procedures between 1980 and 2000, with subsequent segmentation in later years particularly as new minimally invasive procedures were developed towards the end of the 20th century. In the cardiovascular arena, the development of new procedures for angioplasty and bypasses in the late 1980s led to these procedures being performed in increasing numbers. This increase was driven by lowered risk associated with the new procedures, new product availability, and surgeon capability coupled with substantial changes in demographics caused by aging, lifestyle and economics. For example, it is estimated that approximately 20% of the over 80-year-old population suffers from some form of coronary heart disease in the United States, and the development of angioplasty procedures created a new preferable (to open heart surgery) treatment for this population.

Whereas in the United States there were 50,000 open heart surgery treatments in 1980, towards the end of the twentieth century there were 150,000 open heart bypass operations per year. There are approximately 375,000 cardiac vascular reconstruction procedures per year. In cost terms, each angioplasty in the United States costs approximately $8,000 and bypass operations cost approximately $25,000. Surgical closure and securement products are routinely used in these procedures, and new techniques like this cardiovascular example, with associated new technologies, are likely to arise in the next decade to create new market opportunities. 

During this same time frame, spine surgery has also seen tremendous growth, spurred by the combined catalyst of new technology development and an increasingly active and growing senior population.  Until the 1980s spinal surgery focused on multi-level segmental fusion procedures to fuse together several vertebrae to decrease the chance of failure at the bone metal interface. Fixation methods using Harrington hook and rod systems, Luque rods, and wires were used to achieve fusion. These procedures are notable by their invasive nature; they are associated with significant trauma and require substantial rehabilitation care for successful outcome. They were therefore initially used only in extreme cases of congenital deformity and cases of extreme trauma and pain.  In the mid- to late 1980s, a number of manufacturers developed bone screws for use in combination with these hooks and rods, which improved the achievement of stability without requiring multi-level fusion, and the emergence of threaded fusion cages in the mid-1990s added to the surgeon’s treatment options, with resultant increase in fusion success rates. The market for these products grew from tens of millions in 1980 to a $2.4 billion world-wide market in 2000. Use of adjunctive products for surgical closure and securement have already gained foothold in these procedures, which continue to grow.

Less invasive approaches to spine surgery and concomitant technology development have expanded the patient population for spine fusion procedures.   Simultaneously, a persistent demand has existed among a high caseload of patients with spine trauma and disease seeking solutions that diminish or eliminate pain, and yield lasting high quality outcomes including spine flexibility, strength and the opportunity for a more active lifestyle.  These include systems for dynamic stabilization, interspinous process spacers, artificial discs and other products.  The performance of procedures involving these products, while improving broadening the applicable caseload and improving the clinical outcomes of patients, will no less demand the use of advanced surgical closure and securement products to facilitate procedures, reduce complications and optimize results.  Fibrin sealants and glues, high strength glues and hemostasis products have established their current and future places in these fields.

Cardiovascular and spine surgery are two among many surgical fields continuing to grow, driven by patient demand and facilitated by technologies that improve outcomes.  Bariatrics, gynecologics, orthopedics, gastrointestinal and other surgeries are witnessing similar increases in procedure volume.   


See the MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Dynamic stabilization (posterior): interspinous process spacers in spine surgery

Posterior dynamic stabilization systems for use in spine surgery can be roughly divided into interspinous fixation devices and transpedicular fixation devices. Both categories include some devices that have been on the market (sometimes only in the EU) for some time, as well as new devices either still under development or under clinical testing in the US.

Interspinous fixation devices include the X-Stop (Kyphon, now owned by Medtronic), the Wallis (second generation), the DIAM Spinal Stabilization System (Medtronic Sofamor Danek), the coflex (from Paradigm Spine, not yet FDA approved), and the ExtenSure and CoRoent devices (NuVasive).

Interspinous process spacers fall under this category. These devices relieve stress and loading on the intervertebral disc and thus hopefully relieve pain. The spinous processes are the small prominences that are on the very back edge of the spinal column, just under the skin. Because the spinous processes are so close to the skin, interspinous process spacers may be inserted with `minimal cutting and dissection of tissues. The spacers are designed to distract (open up) the foramen, thus giving the nerves more room and relieving painful pinching of the nerves.

Developers of Interspinous Process Spacers

 interspinous-process-spacers

(note: see report #M510 for product status.)

Source: MedMarket Diligence, LLC; Report #M510, "Worldwide Spine Surgery."

These spacers may be inserted under only a mild sedative and local anesthesia, with the patient returning home the same day. The same-day surgery procedure makes this especially attractive to elderly patients, who may not be able to tolerate a longer, more extensive surgery performed under general anesthesia.