Eric has over 20 years of product development experience, with much of that time focused on the medical device industry. He has worked with companies such as Smith & Nephew and Boston Scientific, assisting them in areas of design, development, regulatory and manufacturing. Eric has held engineering and management positions at Integen, Herbst Lazar Bell and HaA Product Development.
Eric graduated from Boston University, magna cum laude, with a degree in manufacturing engineering. He received a 2018 MedTech Breakthrough Award for his work for his outstanding contributions to the OARtrac System.
Eric has over 20 years of product development experience, with much of that time focused on the medical device industry. He has worked with companies such as Smith & Nephew and Boston Scientific, assisting them in areas of design, development, regulatory and manufacturing. Eric has held engineering and management positions at Integen, Herbst Lazar Bell and HaA Product Development.
Eric graduated from Boston University, magna cum laude, with a degree in manufacturing engineering. He received a 2018 MedTech Breakthrough Award for his work for his outstanding contributions to the OARtrac System.
Jake Wakley provides regulatory oversight for Stratus Medical. Jake also serves as Vice President, Quality and Regulatory for Biomerics and is Director of Regulatory and Quality for Med Venture Holdings LLC. Jake has over 17 years of experience in process and quality engineering, operations management, quality management, and regulatory compliance across multiple medical device companies. He has held key management positions at Compeq International, BD Medical, Edwards Lifesciences, and Biomerics.
Jake graduated from BYU with a BS in Chemical Engineering and earned a Master’s of Business Administration from the University of Utah. He is an expert in various disciplines, including risk assessment, root cause analysis, lean manufacturing, and FDA requirements, and has directly developed and managed multiple medical device quality management systems.
Jake Wakley provides regulatory oversight for Stratus Medical. Jake also serves as Vice President, Quality and Regulatory for Biomerics and is Director of Regulatory and Quality for Med Venture Holdings LLC. Jake has over 17 years of experience in process and quality engineering, operations management, quality management, and regulatory compliance across multiple medical device companies. He has held key management positions at Compeq International, BD Medical, Edwards Lifesciences, and Biomerics.
Jake graduated from BYU with a BS in Chemical Engineering and earned a Master’s of Business Administration from the University of Utah. He is an expert in various disciplines, including risk assessment, root cause analysis, lean manufacturing, and FDA requirements, and has directly developed and managed multiple medical device quality management systems.
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.