Executive Vice President Global Marketing of spine device company LDR Joe Ross discusses the non-fusion cervical spine surgery market and where technology is headed in the future.
Q: What alternatives to cervical spinal fusion exist in the spine surgery market?
Joe Ross: There are a few procedures to treat cervical pathologies that do not include fusion. These include cervical disc replacement, foraminotomy and laminoplasty, as examples. For patients with degenerative disc disease with radicular symptoms for which surgery is indicated, the primary alternative to fusion for the foreseeable future is artificial disc replacement. There are several ongoing device trials for cervical disc replacements, including the Mobi-C from LDR.
Q: How will surgeons be able to differentiate the new discs coming on the market?
JR: While there are some similarities to a few devices, either available or anticipated to be available in the U.S., there are some distinct design differences. These differences include materials, fixation features and the way in which motion is provided by the device. Regardless of the specific design features however, another very important consideration when evaluating the devices will be the clinical evidence to support safety and efficacy of the individual device as it relates to its approved indication. Physicians will need to absorb this evidence, along with the approved indications, in order to make a personal determination of what is best for their patient population.
Q: How can motion preservation technology benefit the patient?
JR: When a patient receives a fusion today, normal motion is of course largely eliminated at the operative levels. And in addition to that segmental loss of motion, it is theorized that fusion may transmit increased stress to levels above or below the fused segment(s), and thereby accelerate, or fail to slow further spine degeneration. Potential benefits of disc replacement or motion preservation techniques include more normal motion maintained at the surgical levels, less adjacent level degeneration and fewer additional surgeries in the future. If these potential benefits are proven to be real, then cervical disc replacement could be as revolutionary to cervical spine surgery as hip and knee replacements have been to large joint replacement.
From my personal view, the positive evidence for disc replacements is becoming increasingly clear. With initial studies we saw some trend that appeared to favor cervical disc replacement when compared to ACDF, and now subsequent studies and long-term data is being presented at meetings and published in journals that further supports the safety and efficacy of cervical disc replacements, including potential advantages of lower reoperation rates and lower rates of adjacent segment degeneration. It is important of course to continue to monitor the objective, peer-reviewed clinical evidence. However, I am encouraged that the long-term studies of certain discs being reported seem to be painting an increasingly positive picture.
Q: How big is the field for disc replacement surgery today? Do you see it growing in the future?
JR: Cervical disc replacement is an established, but still emerging market in the United States. Reimbursement coverage is becoming more widespread, and there are an increasing number of choices for physicians when it comes to the cervical disc, as evidenced by two recent approvals of new devices. There are currently five discs approved in the United States for cervical disc replacement, and a few others are expected over the next couple of years, including the Mobi-C from LDR. At that point, there will be a number of options for surgeons. Beyond that though, there is not a great deal on the horizon, and any future products not already undergoing clinical trials will of course be subject to the rigorous, multi-year, study requirements for new technologies.
Q: How can spine surgeons incorporate non-fusion technologies into their practice?
JR: Surgeons must first look at the available evidence and decide whether non-fusion technologies can benefit the patients they treat. If they then decide to incorporate cervical disc replacement into their practices, they can take advantage of the numerous training courses offered around the country. Each manufacturer provides training at various locations for surgeons to familiarize themselves with the techniques and indications for use specific to their device.
Q: What is reimbursement like for cervical disc replacement? Are there any hurdles?
JR: The reimbursement environment for cervical disc replacement is improving but can still be variable by geography. It is always very helpful to be knowledgeable regarding the local payor mix and their individual coverage policies. It is interesting to note that recent coverage policies have been very specific to approved indications and approved devices, which may make it important for physicians to match their patient's surgical need to a device having that approved indication. Overall, I see the trend as being very positive for cervical disc coverage.
Q: What non-fusion technology should spine surgeons look for in the future? Where is the field heading?
JR: The primary new, non-fusion technology for the cervical spine for the foreseeable future remains the cervical disc. The clinical trial requirements in the United States can take six to eight years or more, therefore a next generation of solutions seems quite far out on the horizon.
That said, one significant development may be the expansion of indications to include two level disc replacement via the anticipated two level approval of LDR's Mobi-C Cervical Disc. This will be a important event given the prevalence of two level pathology, and may significantly increase the number of patients eligible to be treated on-label with cervical disc replacement.
Overall, when you consider the growing library of supportive short and long term evidence for cervical disc replacement, new device approvals, the potential for expanded indications and an improving reimbursement environment, the field of non-fusion surgery for the cervical spine is very exciting both for patients and physicians.
More Articles on Spine Surgery:
5 Tips to Get Started With Outpatient Spine Surgery
5 Thoughts on Managing the Online Presence of Spine Surgeons
5 Spine Surgeons on Enduring EMR Adoption
Q: What alternatives to cervical spinal fusion exist in the spine surgery market?
Joe Ross: There are a few procedures to treat cervical pathologies that do not include fusion. These include cervical disc replacement, foraminotomy and laminoplasty, as examples. For patients with degenerative disc disease with radicular symptoms for which surgery is indicated, the primary alternative to fusion for the foreseeable future is artificial disc replacement. There are several ongoing device trials for cervical disc replacements, including the Mobi-C from LDR.
Q: How will surgeons be able to differentiate the new discs coming on the market?
JR: While there are some similarities to a few devices, either available or anticipated to be available in the U.S., there are some distinct design differences. These differences include materials, fixation features and the way in which motion is provided by the device. Regardless of the specific design features however, another very important consideration when evaluating the devices will be the clinical evidence to support safety and efficacy of the individual device as it relates to its approved indication. Physicians will need to absorb this evidence, along with the approved indications, in order to make a personal determination of what is best for their patient population.
Q: How can motion preservation technology benefit the patient?
JR: When a patient receives a fusion today, normal motion is of course largely eliminated at the operative levels. And in addition to that segmental loss of motion, it is theorized that fusion may transmit increased stress to levels above or below the fused segment(s), and thereby accelerate, or fail to slow further spine degeneration. Potential benefits of disc replacement or motion preservation techniques include more normal motion maintained at the surgical levels, less adjacent level degeneration and fewer additional surgeries in the future. If these potential benefits are proven to be real, then cervical disc replacement could be as revolutionary to cervical spine surgery as hip and knee replacements have been to large joint replacement.
From my personal view, the positive evidence for disc replacements is becoming increasingly clear. With initial studies we saw some trend that appeared to favor cervical disc replacement when compared to ACDF, and now subsequent studies and long-term data is being presented at meetings and published in journals that further supports the safety and efficacy of cervical disc replacements, including potential advantages of lower reoperation rates and lower rates of adjacent segment degeneration. It is important of course to continue to monitor the objective, peer-reviewed clinical evidence. However, I am encouraged that the long-term studies of certain discs being reported seem to be painting an increasingly positive picture.
Q: How big is the field for disc replacement surgery today? Do you see it growing in the future?
JR: Cervical disc replacement is an established, but still emerging market in the United States. Reimbursement coverage is becoming more widespread, and there are an increasing number of choices for physicians when it comes to the cervical disc, as evidenced by two recent approvals of new devices. There are currently five discs approved in the United States for cervical disc replacement, and a few others are expected over the next couple of years, including the Mobi-C from LDR. At that point, there will be a number of options for surgeons. Beyond that though, there is not a great deal on the horizon, and any future products not already undergoing clinical trials will of course be subject to the rigorous, multi-year, study requirements for new technologies.
Q: How can spine surgeons incorporate non-fusion technologies into their practice?
JR: Surgeons must first look at the available evidence and decide whether non-fusion technologies can benefit the patients they treat. If they then decide to incorporate cervical disc replacement into their practices, they can take advantage of the numerous training courses offered around the country. Each manufacturer provides training at various locations for surgeons to familiarize themselves with the techniques and indications for use specific to their device.
Q: What is reimbursement like for cervical disc replacement? Are there any hurdles?
JR: The reimbursement environment for cervical disc replacement is improving but can still be variable by geography. It is always very helpful to be knowledgeable regarding the local payor mix and their individual coverage policies. It is interesting to note that recent coverage policies have been very specific to approved indications and approved devices, which may make it important for physicians to match their patient's surgical need to a device having that approved indication. Overall, I see the trend as being very positive for cervical disc coverage.
Q: What non-fusion technology should spine surgeons look for in the future? Where is the field heading?
JR: The primary new, non-fusion technology for the cervical spine for the foreseeable future remains the cervical disc. The clinical trial requirements in the United States can take six to eight years or more, therefore a next generation of solutions seems quite far out on the horizon.
That said, one significant development may be the expansion of indications to include two level disc replacement via the anticipated two level approval of LDR's Mobi-C Cervical Disc. This will be a important event given the prevalence of two level pathology, and may significantly increase the number of patients eligible to be treated on-label with cervical disc replacement.
Overall, when you consider the growing library of supportive short and long term evidence for cervical disc replacement, new device approvals, the potential for expanded indications and an improving reimbursement environment, the field of non-fusion surgery for the cervical spine is very exciting both for patients and physicians.
More Articles on Spine Surgery:
5 Tips to Get Started With Outpatient Spine Surgery
5 Thoughts on Managing the Online Presence of Spine Surgeons
5 Spine Surgeons on Enduring EMR Adoption