Stratus® Medical is committed to an effective Compliance Program in accordance with “Compliance Program Guidance for Durable Medical Equipment, Prosthetics Orthotics and Supply Industry,” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). Our Compliance Program is one of the key components of our commitment to the highest standards of conduct.
Additionally, Stratus Medical follows reporting requirements outlined in Federal Register, published February 8, 2013 by the Department of Health and Human Services, Center for Medicare & Medicaid Services, summary of section 6002 of the Affordable Care Act (“Section 6002 of ACA”).
The purpose of our Compliance Program is to prevent and detect violations of law or company policies. As the HHS-OIG Guidance recognizes, It is our expectation that employees and others working on Nimbus’ behalf will comply with our Code of Conduct, and the policies established in support of the HHS-OIG Guidance and Section 6002 of ACA.
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Background:
Radiofrequency neurotomy (RFN) can be an effective treatment for patients with chronic neck pain and cervicogenic headaches resistant to conservative care. However, the degree and duration of pain relief after RFN is dependent upon the thoroughness of target nerve coagulation.
Case Report:
This is a case of a 37-year-old patient with debilitating neck pain and headaches following a motor vehicle accident. Successful local anesthetic block of the third occipital nerve (TON) confirmed pain of C2-C3 facet joint origin. An initial RFN treatment of the TON, using standard 18G electrodes in bipolar mode, resulted in complete symptom amelioration for 8 months. Repeat RFN, using the same electrode configuration, was unsuccessful in alleviating the severe neck pain and headaches, and produced no demonstrable sensory loss in the distribution of the TON. RFN was then performed using the NIMBUS® electrosurgical RF multitined expandable electrode, which provides a larger zone of coagulation in volume than standard RFN electrodes even when used in bipolar configuration.
Conclusion:
The NIMBUS procedure resulted in successful coagulation of the TON with sensory loss in the TON distribution and reinstatement of palliative relief.
