Laser Spine Institute, based in Tampa, Fla., has launched two new surgical procedures to meet the needs of patients with back pain: RegenaDISC® and Minimally Invasive Stabilization. The two procedures can be performed at Laser Spine Institute's Accreditation Association for Ambulatory Health Care- accredited ambulatory surgery centers as an outpatient procedure for patients with the appropriate indications.
"We started Laser Spine Institute by doing a lot of laser treatments for the disc and that set us apart from other spine centers with the innovation of using lasers to remove, shrink and seal torn tissue in the disc ring," says Michael Weiss, DO, chairman of surgery at Laser Spine Institute. "Over the year we've seen this works well and helps the disc, but it doesn't regenerate the disc; it slows the degenerative process but doesn't stop or reverse it. We are beginning to have those capabilities now with the RegenaDISC procedure."
The RegenaDISC procedure was pioneered by Mark Flood, DO, chief of surgical innovation at Laser Spine Institute, and combines minimally invasive surgical techniques with stem cell treatment. The procedure uses stem cell tissue transplantation to promote regeneration and healing for patients with discogenic back pain from conditions such as a herniated disc, degenerative disc or annular tear. The procedure also uses a low-level laser to stimulate the cells and encourage regeneration.
"Historically these patients have gone onto physical therapy and then a final fusion," says Dr. Flood. "RegenaDISC brings a biologic answer to back pain. The stem cells reduce inflammation and provide the necessary blocks for the disc to regenerate. This is an alternative for irreversible spinal fusion for patients who fail conservative treatment."
Minimally Invasive Stabilization at Laser Spine Institute includes cervical and lumbar minimally invasive fusion procedures. The technique is a muscle sparing procedure designed to treat a wide range of conditions, including spinal stenosis and instability, myelomalacia and unstable spines.
"We are very excited to expand our offerings as a leader in surgical spine care and we think these new procedures will open up the number of patients we can help who seek our care," says Dotty Bollinger, Chief Operating Officer of Laser Spine Institute. "What we are doing is bringing the business of spine care to the patient and putting the patient first. We are simply giving patients what they are asking for and we believe that's why we have continued to be the leader in spine care."
Here, Dr. Flood, Dr. Weiss, Laser Spine Institute Medical Director Michael Perry, MD, and Ms. Bollinger discuss these new procedures and how they will influence spine surgery in the outpatient setting.
Q: Dr. Flood, what was the process of developing and incorporating the RegenaDISC procedure into your practice?
Dr. Mark Flood: The RegenaDISC procedure has been in the making for a couple of years. I traveled a lot and attended many lectures, talking to scientists around the United States and read articles in journals trying to determine the best way to bring meaningful biologic treatment to patients with disc pain. I traveled to Moscow and Dubai to determine what the best way to treat patients would be. There is a lot of good information about the science of treating back pain, but translating that knowledge to the patient has not been done.
It was a two-year process to put it all together using stem cells, platelet-rich plasma and a low level laser. It took a while to develop the optimum method and bring a meaningful procedure together, but we have done it and are excited by the results.
Q: What are the benefits for the patient in performing the RegenaDISC procedure?
MF: The benefit is that it directly treats the cause of pain, inflammation and degeneration in the disc. These things are typically hard to manage because the disc doesn't have a good blood supply. Getting the cells into the disc where they can be effective is important; this procedure is the direct application of living cells, which can reduce inflammation in the disc. The cells also provide a building block for treating the spine; when we age we have chondrocyte-like cells in the disc and the procedure cells give it a hydrolic mechanism. Stem cells can differentiate into these cells when they are applied to the environment, which gives us an option for regeneration.
Dotty Bollinger: RegenaDISC offers minimally invasive alternatives to patients who don't have the option of fusion. Patients receive their own autologous stem cells placed directly into the disc. We use a low level laser to stimulate those cells, which encourages the regeneration. Stem cell science is emerging and we are closely tracking our outcomes with patients. So far, we are very excited because we are seeing favorable outcomes with that.
Dr. Michael Perry: A lot of people were once precluded from surgery at our centers and we had to source them out for spine surgery or fusion. Recently we decided to do these procedures ourselves. RegenaDISC is stem cell injections into the disc that can help people who are suffering from discogenic back pain. We are really excited about it because we will be able to help patients who we wouldn't have been able to treat otherwise.
Dr. Michael Weiss: RegenaDISC is a new form of stem cell therapy where we still use the laser but we have introduced stem cells and health disc tissue to the bad disc in the hopes that we can now stop the degeneration process and then regenerate the disc tissue. This is the first change in the past 15 years to come along where we have been able to use the laser on different settings that allows for stimulation on the disc material and adding something to support that stimulation.
We can take the stem cells and put them in an environment where they can co-mingle with stimulated disc cells in the bad disc and maybe even add some better normal disc cells, which will tip the scale in favor of the patient by allowing the undifferentiated stem cells to be presupposed to turn into new disc cells in the process.
Q: What are the benefits of the Minimally Invasive Stabilization procedure?
MF: MIS is a stabilization procedure and traditionally was performed through an open back procedure, which can result in significant damage to the muscles surrounding the spine. With the minimally invasive approach, there is less scarring and a quicker recovery. The procedures are now done through a smaller incision and at an outpatient surgery center, which has a lower infection rate and lower costs when compared to the traditional open procedure at a hospital. The goal is still to remove the source of the patient's pain without disrupting the muscles to the spine.
Some of the devices now are being designed for MIS stabilization, but the goal of the procedure is still the same. At Laser Spine Institute, we do a true outpatient surgery; no one stays here overnight for 23 hours. We can manage the postoperative pain so patients don't have to stay — they are all discharged the same day.
MW: Minimally Invasive Stabilizations are procedures that have been revised over the years. In the hospital, it was a big open procedure where muscles were split and rods and screws where placed in the back for a traditional fusion. There was more bleeding, increased scarring and more pain that couldn't be controlled with just oral medications. With MIS, we've taken the techniques that have been perfected over the past eight years at Laser Spine Institute and applied them to what has been done as an open fusion procedure.
The incisions are smaller and we are able to put instrumentation in, such as a cage, in the spaces between the ones of the spine. Fixation is placed posterially to allow for a solid front and back stabilization for the patient. There is little blood loss, pain is managed during surgery and the postoperative period and patients are able to go home with oral pain medications. Their recovery time is quicker and the procedure is also faster, which is one of the major advantages of this technique. The patient's ability to keep their muscles intact and maintain stabilization has been huge for patients who aren't candidates for the endoscopic laser spine surgeries we do.
MP: We felt with the way technology is now, we could safely perform this procedure in an outpatient setting. It was something we had talked about in the past but didn't have the technology or instrumentation, but now we can take them on. It's beneficial because there are fewer infections at outpatient surgery centers and the complications are minimal when the procedure isn't an open technique. Typically, people undergoing multi-level fusions could be out of work for weeks or months; after MIS, they can return to work in a few weeks.
Q: What does it take to bring these procedures into an outpatient surgery center?
MF: It takes quite a bit of effort on the behalf of all of the staff including the preoperative and postoperative nurses, surgeons, scrub techs and nursing staff. All of the staff members need to be educated and trained on the newer methods. There is a lot to learn from for all of the staff members, so it's truly a group effort from the moment surgeons walk in the door. The postoperative effort and X-ray technicians also have a big role to play in developing the MIS stabilization program.
Each procedure has its own set of challenges, and so far we have been very good at managing all of them. We have introduced one procedure at a time and so far we have been pleased with all of the outcomes.
DB: We brought Dr. Flood on board as an expert earlier this year. We had to secure capital equipment to process the stem cells and other equipment for the operating rooms to do these procedures. We had to train others to help during the procedure. There was a capital outlay for it, but the procedures can be negotiated with insurance companies. Even RegenaDISC can be negotiated because the procedure is done in conjunction with stem cell therapy.
We operate under an environment that supports change. We are always looking to advance, so surgical innovation is our wheel house. We had to bring in new equipment and do staff training, but we are very fortunate to have employees who come in every day looking for the next best thing to help our patients and put our patients first.
Q: What were the challenges of bringing these procedures into the surgery center?
MW: We are one of the largest outpatient spine centers in the country with respect to the number of patients we treat every month, and with our centers we have become adept to caring for spinal conditions in the ASC, so this was a natural progression for us. We have the ability to do the procedure under sedation and do it within a 30 minute window. The patients don't need any specialized prep work or inpatient-type procedures to take advantage of this technology.
For RegenaDISC, the cells are readily available and implantable in the bone marrow, accessible by needle. The whole procedure from harvesting the stem cells to the surgery takes more than an hour, but as we start to do more we will get those times down.
MP: We had to make several adjustments in OR times. The procedure takes slightly longer than our other endoscopic procedures. We also had to bring in special equipment and train personnel to use that equipment for these unique procedures. Anyone undergoing the MIS procedure must be under general anesthesia, so we had to adjust the procedure timing for that as well.
Q: How does bringing these procedures to the outpatient setting impact Laser Spine Institute?
DB: These procedures really expand our offerings to a wider audience. The primary patients for the RegenaDISC procedure are those with annular tears or low back pain but no radicular pain. Before RegenaDISC, these patients only had a few options. Dr. Flood brought this proprietary procedure to Laser Spine Institute and we are proud to offer it here.
Providing the MIS procedure also expands our audience. We've helped more than 25,000 surgical patients and now we can reach an even wider patient base. Patients are researching on the internet and often come to surgeons with a lot of information; they are looking for the least invasive procedure so they can return to work and daily living in a pain free environment as soon as possible.
MF: These procedures offer the opportunity to treat patients we weren't able to help before. If you fail physical therapy, the only other option before was fusion. Now we have the opportunity to perform these procedures that can help a lot of patients. Laser Spine Institute has been meeting the needs of patients before they need a spinal fusion, and the MIS procedure allows us to provide them with the continuity of care.
We also use an endoscope rather than a microscope or loops and that provides us with the ability to use an even smaller incision than would traditionally be used in even minimally invasive surgery. We are doing 360 fusions and TLIFs with a technique that nobody else in the world is using today.
Q: Where do you see these procedures heading in the future?
MW: From an evolution standpoint, for us in particular, these procedures allow us to provide care for a larger spectrum of spine patients. We see patients with bone on bone pain that need something to stabilize the disc space and patients with instabilities who could benefit from our procedures. Most of the time, these patients were sent to a hospital for a costly surgery and hospital stay.
The natural evolution will allow more patients to take advantage of minimally invasive procedures so they can get back to work sooner, back to their lives quicker and have a shorter rehabilitation period. All these things will be available to more patients going forward. The evolution will move toward more technology, smaller incisions and more effective implants. These procedures will become smaller and more efficient with time.
MP: Looking into the future, I compare spine surgery to knee surgeries. Years ago, knee surgeries were done as open procedures with a large incision in the front of the knee; now surgeons are doing most of these procedures arthroscopically. I think the endoscopic procedures in spine surgery are eventually going to be the standard of care. I also think in the near future you are going to be doing an endoscopic fusion procedure. I see it becoming less invasive and treating patients with a wider variety of spinal conditions.
For stem cells, we have only scratched the surface of what they can offer for regeneration of certain tissues. We want to understand it and the science behind it better to treat spinal conditions. We could treat conditions we wouldn't have considered in the past using stem cells. I think that the future for any spine center 40 to 50 years down the road is biologics. It's amazing how science has progressed and eventually we might be able to do surgery without cutting the surface of the skin and just using laser technology. That's where I see spine surgery going.
MF: One of our challenges so far is that we only do single-level lumbar patients and there is the possibility to advance this to two level lumbar patients where there is more than one level pathology, and that would certainly be a milestone. It requires better postoperative pain management and likely an even smaller incision.
We can currently do minimally invasive stabilization cervical cases through a very small incision for the ACDF. This procedure uses newer implants with a complete decompression of the spinal cord, which is done on an outpatient basis.
More Articles on Spine Surgery:
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"We started Laser Spine Institute by doing a lot of laser treatments for the disc and that set us apart from other spine centers with the innovation of using lasers to remove, shrink and seal torn tissue in the disc ring," says Michael Weiss, DO, chairman of surgery at Laser Spine Institute. "Over the year we've seen this works well and helps the disc, but it doesn't regenerate the disc; it slows the degenerative process but doesn't stop or reverse it. We are beginning to have those capabilities now with the RegenaDISC procedure."
The RegenaDISC procedure was pioneered by Mark Flood, DO, chief of surgical innovation at Laser Spine Institute, and combines minimally invasive surgical techniques with stem cell treatment. The procedure uses stem cell tissue transplantation to promote regeneration and healing for patients with discogenic back pain from conditions such as a herniated disc, degenerative disc or annular tear. The procedure also uses a low-level laser to stimulate the cells and encourage regeneration.
"Historically these patients have gone onto physical therapy and then a final fusion," says Dr. Flood. "RegenaDISC brings a biologic answer to back pain. The stem cells reduce inflammation and provide the necessary blocks for the disc to regenerate. This is an alternative for irreversible spinal fusion for patients who fail conservative treatment."
Minimally Invasive Stabilization at Laser Spine Institute includes cervical and lumbar minimally invasive fusion procedures. The technique is a muscle sparing procedure designed to treat a wide range of conditions, including spinal stenosis and instability, myelomalacia and unstable spines.
"We are very excited to expand our offerings as a leader in surgical spine care and we think these new procedures will open up the number of patients we can help who seek our care," says Dotty Bollinger, Chief Operating Officer of Laser Spine Institute. "What we are doing is bringing the business of spine care to the patient and putting the patient first. We are simply giving patients what they are asking for and we believe that's why we have continued to be the leader in spine care."
Here, Dr. Flood, Dr. Weiss, Laser Spine Institute Medical Director Michael Perry, MD, and Ms. Bollinger discuss these new procedures and how they will influence spine surgery in the outpatient setting.
Q: Dr. Flood, what was the process of developing and incorporating the RegenaDISC procedure into your practice?
Dr. Mark Flood: The RegenaDISC procedure has been in the making for a couple of years. I traveled a lot and attended many lectures, talking to scientists around the United States and read articles in journals trying to determine the best way to bring meaningful biologic treatment to patients with disc pain. I traveled to Moscow and Dubai to determine what the best way to treat patients would be. There is a lot of good information about the science of treating back pain, but translating that knowledge to the patient has not been done.
It was a two-year process to put it all together using stem cells, platelet-rich plasma and a low level laser. It took a while to develop the optimum method and bring a meaningful procedure together, but we have done it and are excited by the results.
Q: What are the benefits for the patient in performing the RegenaDISC procedure?
MF: The benefit is that it directly treats the cause of pain, inflammation and degeneration in the disc. These things are typically hard to manage because the disc doesn't have a good blood supply. Getting the cells into the disc where they can be effective is important; this procedure is the direct application of living cells, which can reduce inflammation in the disc. The cells also provide a building block for treating the spine; when we age we have chondrocyte-like cells in the disc and the procedure cells give it a hydrolic mechanism. Stem cells can differentiate into these cells when they are applied to the environment, which gives us an option for regeneration.
Dotty Bollinger: RegenaDISC offers minimally invasive alternatives to patients who don't have the option of fusion. Patients receive their own autologous stem cells placed directly into the disc. We use a low level laser to stimulate those cells, which encourages the regeneration. Stem cell science is emerging and we are closely tracking our outcomes with patients. So far, we are very excited because we are seeing favorable outcomes with that.
Dr. Michael Perry: A lot of people were once precluded from surgery at our centers and we had to source them out for spine surgery or fusion. Recently we decided to do these procedures ourselves. RegenaDISC is stem cell injections into the disc that can help people who are suffering from discogenic back pain. We are really excited about it because we will be able to help patients who we wouldn't have been able to treat otherwise.
Dr. Michael Weiss: RegenaDISC is a new form of stem cell therapy where we still use the laser but we have introduced stem cells and health disc tissue to the bad disc in the hopes that we can now stop the degeneration process and then regenerate the disc tissue. This is the first change in the past 15 years to come along where we have been able to use the laser on different settings that allows for stimulation on the disc material and adding something to support that stimulation.
We can take the stem cells and put them in an environment where they can co-mingle with stimulated disc cells in the bad disc and maybe even add some better normal disc cells, which will tip the scale in favor of the patient by allowing the undifferentiated stem cells to be presupposed to turn into new disc cells in the process.
Q: What are the benefits of the Minimally Invasive Stabilization procedure?
MF: MIS is a stabilization procedure and traditionally was performed through an open back procedure, which can result in significant damage to the muscles surrounding the spine. With the minimally invasive approach, there is less scarring and a quicker recovery. The procedures are now done through a smaller incision and at an outpatient surgery center, which has a lower infection rate and lower costs when compared to the traditional open procedure at a hospital. The goal is still to remove the source of the patient's pain without disrupting the muscles to the spine.
Some of the devices now are being designed for MIS stabilization, but the goal of the procedure is still the same. At Laser Spine Institute, we do a true outpatient surgery; no one stays here overnight for 23 hours. We can manage the postoperative pain so patients don't have to stay — they are all discharged the same day.
MW: Minimally Invasive Stabilizations are procedures that have been revised over the years. In the hospital, it was a big open procedure where muscles were split and rods and screws where placed in the back for a traditional fusion. There was more bleeding, increased scarring and more pain that couldn't be controlled with just oral medications. With MIS, we've taken the techniques that have been perfected over the past eight years at Laser Spine Institute and applied them to what has been done as an open fusion procedure.
The incisions are smaller and we are able to put instrumentation in, such as a cage, in the spaces between the ones of the spine. Fixation is placed posterially to allow for a solid front and back stabilization for the patient. There is little blood loss, pain is managed during surgery and the postoperative period and patients are able to go home with oral pain medications. Their recovery time is quicker and the procedure is also faster, which is one of the major advantages of this technique. The patient's ability to keep their muscles intact and maintain stabilization has been huge for patients who aren't candidates for the endoscopic laser spine surgeries we do.
MP: We felt with the way technology is now, we could safely perform this procedure in an outpatient setting. It was something we had talked about in the past but didn't have the technology or instrumentation, but now we can take them on. It's beneficial because there are fewer infections at outpatient surgery centers and the complications are minimal when the procedure isn't an open technique. Typically, people undergoing multi-level fusions could be out of work for weeks or months; after MIS, they can return to work in a few weeks.
Q: What does it take to bring these procedures into an outpatient surgery center?
MF: It takes quite a bit of effort on the behalf of all of the staff including the preoperative and postoperative nurses, surgeons, scrub techs and nursing staff. All of the staff members need to be educated and trained on the newer methods. There is a lot to learn from for all of the staff members, so it's truly a group effort from the moment surgeons walk in the door. The postoperative effort and X-ray technicians also have a big role to play in developing the MIS stabilization program.
Each procedure has its own set of challenges, and so far we have been very good at managing all of them. We have introduced one procedure at a time and so far we have been pleased with all of the outcomes.
DB: We brought Dr. Flood on board as an expert earlier this year. We had to secure capital equipment to process the stem cells and other equipment for the operating rooms to do these procedures. We had to train others to help during the procedure. There was a capital outlay for it, but the procedures can be negotiated with insurance companies. Even RegenaDISC can be negotiated because the procedure is done in conjunction with stem cell therapy.
We operate under an environment that supports change. We are always looking to advance, so surgical innovation is our wheel house. We had to bring in new equipment and do staff training, but we are very fortunate to have employees who come in every day looking for the next best thing to help our patients and put our patients first.
Q: What were the challenges of bringing these procedures into the surgery center?
MW: We are one of the largest outpatient spine centers in the country with respect to the number of patients we treat every month, and with our centers we have become adept to caring for spinal conditions in the ASC, so this was a natural progression for us. We have the ability to do the procedure under sedation and do it within a 30 minute window. The patients don't need any specialized prep work or inpatient-type procedures to take advantage of this technology.
For RegenaDISC, the cells are readily available and implantable in the bone marrow, accessible by needle. The whole procedure from harvesting the stem cells to the surgery takes more than an hour, but as we start to do more we will get those times down.
MP: We had to make several adjustments in OR times. The procedure takes slightly longer than our other endoscopic procedures. We also had to bring in special equipment and train personnel to use that equipment for these unique procedures. Anyone undergoing the MIS procedure must be under general anesthesia, so we had to adjust the procedure timing for that as well.
Q: How does bringing these procedures to the outpatient setting impact Laser Spine Institute?
DB: These procedures really expand our offerings to a wider audience. The primary patients for the RegenaDISC procedure are those with annular tears or low back pain but no radicular pain. Before RegenaDISC, these patients only had a few options. Dr. Flood brought this proprietary procedure to Laser Spine Institute and we are proud to offer it here.
Providing the MIS procedure also expands our audience. We've helped more than 25,000 surgical patients and now we can reach an even wider patient base. Patients are researching on the internet and often come to surgeons with a lot of information; they are looking for the least invasive procedure so they can return to work and daily living in a pain free environment as soon as possible.
MF: These procedures offer the opportunity to treat patients we weren't able to help before. If you fail physical therapy, the only other option before was fusion. Now we have the opportunity to perform these procedures that can help a lot of patients. Laser Spine Institute has been meeting the needs of patients before they need a spinal fusion, and the MIS procedure allows us to provide them with the continuity of care.
We also use an endoscope rather than a microscope or loops and that provides us with the ability to use an even smaller incision than would traditionally be used in even minimally invasive surgery. We are doing 360 fusions and TLIFs with a technique that nobody else in the world is using today.
Q: Where do you see these procedures heading in the future?
MW: From an evolution standpoint, for us in particular, these procedures allow us to provide care for a larger spectrum of spine patients. We see patients with bone on bone pain that need something to stabilize the disc space and patients with instabilities who could benefit from our procedures. Most of the time, these patients were sent to a hospital for a costly surgery and hospital stay.
The natural evolution will allow more patients to take advantage of minimally invasive procedures so they can get back to work sooner, back to their lives quicker and have a shorter rehabilitation period. All these things will be available to more patients going forward. The evolution will move toward more technology, smaller incisions and more effective implants. These procedures will become smaller and more efficient with time.
MP: Looking into the future, I compare spine surgery to knee surgeries. Years ago, knee surgeries were done as open procedures with a large incision in the front of the knee; now surgeons are doing most of these procedures arthroscopically. I think the endoscopic procedures in spine surgery are eventually going to be the standard of care. I also think in the near future you are going to be doing an endoscopic fusion procedure. I see it becoming less invasive and treating patients with a wider variety of spinal conditions.
For stem cells, we have only scratched the surface of what they can offer for regeneration of certain tissues. We want to understand it and the science behind it better to treat spinal conditions. We could treat conditions we wouldn't have considered in the past using stem cells. I think that the future for any spine center 40 to 50 years down the road is biologics. It's amazing how science has progressed and eventually we might be able to do surgery without cutting the surface of the skin and just using laser technology. That's where I see spine surgery going.
MF: One of our challenges so far is that we only do single-level lumbar patients and there is the possibility to advance this to two level lumbar patients where there is more than one level pathology, and that would certainly be a milestone. It requires better postoperative pain management and likely an even smaller incision.
We can currently do minimally invasive stabilization cervical cases through a very small incision for the ACDF. This procedure uses newer implants with a complete decompression of the spinal cord, which is done on an outpatient basis.
More Articles on Spine Surgery:
10 Top Issues for Spine Surgeons After the Supreme Court Upheld Healthcare Reform
The Most Important Issues Facing Spine Surgeons: Q&A With ISASS President Dr. Steven Garfin
20 Spine Devices Receive FDA 510(k) Clearance in June