Spine surgery is becoming less invasive and procedures are moving into the outpatient setting to improve quality and reduce costs. Paradigm Spine has trained more than 1,000 surgeons in the coflex procedure for less invasive spine surgery and armed with new payment coverage recommendations from the International Society for the Advancement of Spine Surgery, 2017 is shaping up as an exciting year.
Q: Where does coflex — interlaminar stabilization — fit into the evolution of spine procedures?
Marc Viscogliosi: Coflex is a versatile product that's on label for a variety of spinal issues and around 60 percent of spinal stenosis patients are candidates for coflex. The reoperation rates are lower and the follow-up care is less expensive, so the hard and soft savings are significant.
The coflex procedure is well positioned for spine surgeons to provide for appropriately indicated patients in the right environment and dynamic that is consistent with providing the best outcomes for patients. We are excited about the long term data comparing coflex against fusion and decompression. We have society guidelines and recommendation, as well as coding alignment for all sites of service in the inpatient and outpatient setting.
It took a long time to get to that point. We developed clinical evidence and continue to support our research efforts. The biggest investments we make every year are supporting the clinical research and evidence on product utilization; a lot of that isn't expanding the label or applications per se, but to understand where we get the optimal outcomes for coflex and identifying the right patient population.
In some cases, that's a significant undertaking.
Q: How do you see the healthcare landscape changing after President Trump's inauguration? What does that mean for the spine field?
MV: From a healthcare perspective, President Trump and the Republican Senate and Congress will repeal ObamaCare and put in place a replacement plan. One of the brilliant aspects of ObamaCare was they opened access to insurance for a lot of patients. What will be a great opportunity for the next administration is to figure out the most economical and affordable way to pay for the change in the healthcare environment in a way that aligns with the its core principles: efficiency and cost-effectiveness. You don't want to have the same enrollment issues with the exchanges and insurance companies.
As we all know, it will take several years for any changes to roll out.
For spine in general, there are less invasive products and procedures that will help facilitate the shift to more outpatient and ASC-type procedures.
Q: How many surgeons are using coflex currently?
MV: We have more than 1,000 surgeons performing coflex cases, and with society guidelines introduced to support coverage, the peer-to-peer conversation becomes significant. The peer-to-peer conversation also resonates in the patient community as patients talk to other patients and their physicians about the procedure. You start to get the patient networking effect, and that becomes a very exciting scenario.
We've started building a field based model in addition to a sales force. The field based model is based on medical science liaisons that take the lead with evidence and data awareness to clinicians. They educate practices and surgical sites about coflex and maintain a dialogue so the device is at the forefront. As the product moves to a standard of care procedure with the amount of evidence it has, it will continue to reinforce coflex as a meaningful clinical solution for a large number of patients.
Q: Where do you see the company heading in 2017?
MV: We expect data to be published on a German study in decompression with coflex and decompression alone—that's going to be a landmark study. We have a few other significant studies underway, including a prospective, cohort-controlled community use study recording the patient-reported outcomes over 25 sites in the United States that weren't involved in previous clinical studies.
We are also conducting a retrospective study looking at coflex utilization data for approximately 3,000 patients at approximately 40 clinical sites. That combination of the US IDE studies, German study, prospective study and retrospective study allows us to have data on thousands of patients and helps validate at the highest levels of science that the product is safe, effective and provides tremendous clinical value.