Spine Technology News Highlights June 2018

Investigational PEEK-on-ceramic cervical artificial disc; Online academic pain medicine programs ideal for spine practitioners; NASS spine registry launched

Innovative Cervical Spinal Disc Device Designed to Reset the Bar for Biocompatibility on Many Levels

SpineUniverse recently spoke with David Hovda, Chief Executive Officer of Simplify Medical, about the SimplifyTM artificial cervical disc. “The design of the Simplify™ Disc is based on 5 years of experience with a previous device, and we’ve tried to incorporate all of our lessons learned into the Simplify Disc,” stated Hovda. At this time, the Company has completed enrollment of its 1-level trial (n=166) and expects to complete enrollment of its 2-level clinical trial (n=200) by the end of 2018. “We are documenting clinical performance in both 1- and 2-level applications, which only Medtronic and LDR (now Zimmer Biomet) have done to date,” he mentioned.

The Simplify™ Disc is a dome-shaped PEEK-on-ceramic motion-preserving cervical artificial disc composed of surgical-grade polymer endplates and mobile ceramic core. “We chose a PEEK-on-ceramic design for several reasons, but primarily to enable and improve MRI imaging,” Hovda said. MRI does not expose patients to ionizing radiation, whereas an average cervical spine CT scan exposes a patient to about 5 millisieverts of radiation, which is equivalent to 400 or 500 chest x-rays. We’re seeking to prevent unnecessary CT scans while allowing surgeons to use their preferred, less detrimental imaging modality. So, there is not only a health and safety component but the disc also allows surgeons to use what they prefer diagnostically.”

Simplify’s PEEK-on-ceramic design also eliminates metal wear from the articulation to optimize functionality and long-term durability. From a biocompatibility and design perspective, Hovda told SpineUniverse, “by avoiding cobalt chrome, we could also avoid nickel in the device making the disc viable for patients allergic to nickel.”

Simplify® is also the first 4mm disc and offers a range of device heights that better fit patients’ anatomies, particularly women, compared to much taller competitive discs. Hovda explained that based on published literature and patients in their clinical trials, the average cervical disc height is about 4mm. “We wanted to better match our implant to the actual anatomies of a vast majority of patients and worked hard to design a disc that does just that.”

The Simplify™ Disc is an investigational device in the United States and is limited by law to investigational use.


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Pain Medicine Master and Certificate Degrees: Online Academic Programs for Spine Practitioners

Registration Deadline: August 15, 2018

The Pain Medicine Master and Certificate programs are a joint venture between the Keck School of Medicine of the University of Southern California (USC) and the Herman Ostrow School of Dentistry of USC—and the programs leverage pain experts from both prestigious institutions as faculty. Below is a snapshot of the programs.

  1. Master of Science in Pain Medicine
    Completed in 37 months, this program includes 25 core courses along with 2 electives. Coursework focuses on a wide spectrum of areas related to pain, including pain conditions, neuroscience, psychological aspects, pain assessment and classification, and legal issues.
  2. Certificate in Pain Medicine
    Completed in 12.5 months, this program includes 7 courses derived from the master's degree.

Both programs align with the current National Pain Strategy (NPS) professional education and training recommendations, which focus on steps to improve discipline-specific core competencies, including basic knowledge, assessment, effective team-based care, empathy, and cultural competency.

Spine Practitioners Ideally Suited for the Programs
The Master of Science in Pain Medicine and Certificate degrees are academic programs—they are not clinical certifications, licenses, or fellowships. As such, Steven Richeimer, MD, said qualified applicants should be licensed clinicians, such as physicians, dentists, nurses, physical and occupational therapists, psychologists, and pharmacists. Dr. Richeimer is Chief, Division of Pain Medicine, Professor of Anesthesiology and Psychiatry, and Director of the Online Master’s Degree in Pain Medicine at USC’s Keck School of Medicine.

“Spine specialists, in particular, are ideal candidates for the programs,” stated Dr. Richeimer. “The No. 1 thing spine specialists deal with is pain, and, a huge segment of the spine clinical world doesn’t recognize all the options—and pitfalls—out there to treat chronic pain. Spine clinicians—whether a physical therapist or nurse or spine surgeon—will come away from these programs with an enriched sense of how to handle these issues in their practices.”


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North American Spine Society’s Multidisciplinary Spine Registry

The North American Spine Society (NASS) launched its diagnosis-based, multidisciplinary spine registry—a web-based tool for spine care providers in the United States. The primary purpose of the registry is to improve spine care.

“Despite the fact that more than 90% of spine care is managed without surgery, most existing registries are focused around surgical specialties or procedures. Thanks to the comprehensive nature of this registry, we will be able to see what care approaches are actually helping patients restore their function and reduce pain,” stated Daniel Resnick, MD, MS, NASS President and Chair of the NASS Registry Committee.1

Reference:
1. NASS Launches Multidisciplinary Spine Registry to “Collect, Measure, Care”. June 25, 2018. https://www.spine.org/Portals/0/Documents/PressReleases/2018/NASSLaunchesSpineRegistry.pdf

Updated on: 07/16/18
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