Jeffrey C. Felt, MD, CEO of Vertebral Technologies, Inc., discusses the company's InterFuseLTM technology and where the spine device field is headed in the future.
Q: What is unique about the InterFuse L? How does it currently fit into the spine device market?
Dr. Jeffrey Felt: There are currently six to eight lateral systems available on the market from different companies. What makes InterFuse L unique is its modularity. It comes in two parts, allowing surgeons to decrease the access channel and size of the annulotomy while still producing one of the largest footprints available with any implant.
The large implant supports the end plates, reduces the amount of subsidence patients are subjected to and lowers the chance of implant migration. Our modular implant system includes instruments to simplify the insertion and placement of the interlocking modules, creating the large footprint coverage from a minimally invasive access channel.
The other positive aspect of the modularity is that the small access channel allows surgeons to go a little further anteriorly and yet not impinge on the anterior longitudinal ligament. By being a bit more anterior we are able to put less pressure and trauma on the lateral plexus of the nerves along the lateral aspect of the spine, reducing the chance of the patient having postoperative pain common with lateral surgery.
Q: What clinical advantages are there for using the lateral approach?
JF: The lateral approach is becoming quite popular for several reasons. When you compare it to the ALIF, there is a smaller chance of vascular injury or injury to the viscera because you don't have to do the abdominal approach. The lateral approach is much less traumatic for the patient and you can achieve as much, or more, end plate coverage than you can with an ALIF implant.
With respect to the posterior surgery — TLIF or PLIF — there is less deep back muscle dissection with the lateral approach. Patients tend to get back on their feet quicker than they do with the standard posterior approaches. The larger footprint with less nerve trauma provides faster and better recovery for patients.
Q: Are there any advantages for surgeons performing the procedure?
JF: Yes — with the standard lateral approach, performing surgery for DDD at L4-5 is difficult because the implant is large and tends to result in pressure on the lateral plexus. With our modular implant, the physician should be able to do an L4-5 very effectively without patients experiencing thigh pain or causing impingement on the anterior longitudinal ligament. We think that with this approach we are going to be able to address L5-S1 in the future.
Q: How was the technology developed? What challenges did you have bringing it to the market?
JF: The InterFuse L was an extension of our modular technology. We have a direct posterior approach — unilateral PLIF — that received FDA clearance in 2008. It was the initial modular product and from there we developed a TLIF approach with three modules. Later we found that developing a modular approach with a smaller access channel and annulotomy would also be beneficial for the lateral approach.
One hurdle for us was the large number of different sizes required. Manufacturing the modular implants was a big resource constraint for us. Our first lateral group had 16 different implant sizes. We hope to eventually expand that number to about 64 different sizes, including a 26mm A/P size.
Q: How can surgeons incorporate this type of technology into their practices? What does it take to become familiar with the lateral technique and this technology?
JF: Any surgeon who has done a lateral implant in the past will be able to learn this technique quite easily. We can teach them in our half-day cadaver lab and they'll get up to speed quickly if they have had experience with the lateral approach.
If this is their first time doing the lateral approach, we recommend a full day cadaver lab. The surgeons can bring their surgical techs and ask questions if they have any issues with positioning (which helps the procedure go smoothly).
Q: What do you see as the biggest opportunity for further development and advancement in the spine device field?
JF: The key is going to be providing better outcomes with less trauma while controlling costs. The modular devices allow surgeons to place large footprint devices through a small access channel, which should help to limit migration, subsidence and postoperative pain. We think the combination of the large stable footprint and the minimally invasive or small access open surgery is going to be the direction of the future.
Q: How does lowering the cost of care impact spine device companies?
JF: For spine companies, there is going to be a lot of price pressure from third party payers and the real challenge is to provide patients with the best implant possible and not make cheap "me too" copies of what has been out on the market for the past 20 years. Our challenge is to improve our manufacturing and control as many aspects of it as possible so we can continue to provide the best implants for patients at a price that is within the means of third party payers.
Q: What goals does Vertebral Technologies have for the future to remain successful in today's spine and healthcare markets?
JF: We want to continue to improve our instruments and implants to make our system the most user-friendly for surgeons; provide the most consistent positive outcomes for patients; and provide our products at a reasonable cost so we can expand throughout the market and provide a benefit to a large number of patients and providers. Even though we are a small company, in meeting these goals we are gaining recognition for our efforts and look forward to our future success.
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