Solving Spinal Surgery's "I Need A Third Hand" Dilemma
By Bob Marshall, Chief Editor, Med Device Online
Facet joints are the joints between your vertebrae that guide your spine’s movement. There are two facet joints between each vertebra — one on each side — and a total of 26 matched sets of facet joints from your neck all the way down to the lumbar part of your spine. Facet joint pain can occur because of use over time (age), arthritis, or injury, and can result in chronic back pain. Facet joint pain can be difficult to diagnose and often is determined based on the pain relief received from conventional treatment approaches.
Chronic facet joint pain is defined as pain originating in the facet joints that has lasted at least three months. Facet joint disorders can cause recurrent, debilitating low back pain, resulting in reduced mobility and decreased quality of life. Current treatment options for facet joint pain include lifestyle changes, weight reduction, injections of pain relief medication, and a procedure known as radio frequency ablation. Unfortunately, these conventional approaches only result in temporary relief and often require patients to return for follow-up treatments.
“About 10 percent of adults suffer from chronic back pain and 31 percent of those cases have facet joint involvement,” said Patrick Kullmann, president & COO of Medovex Corporation, makers of the DenerveX system.
DenerveX Secret Sauce
The concepts behind the DenerveX system were invented by Dr. Scott Haufe, an anesthesiologist/pain management physician. He had performed a manual procedure (similar to what the DenerveX does) using separate instruments that already were FDA cleared. Of the patients he treated, approximately 75 percent had a 50 percent or greater reduction in pain at 3-6 years. However, it was very difficult to navigate the use of multiple instruments with just two hands.
“Dr. Haufe came up with the idea of putting both a tissue-scraping mechanism and a radio-frequency ablation instrument on one shaft. The DenerveX device today is powered by an exclusive electro-surgical generator that rotates the shaft at only 45 RPM, and heats the element at the end of the tip so it actually burns and destroys the tissue on the posterior side of the affected facet joint capsule,” explained Kullman. “Performing the procedure with the DenerveX system covers a larger area. So, now we’re destroying the main nerve that leads to the facet joint, and also destroying the nerve end-plate receptors and a portion of the facet joint tissue capsule. That’s the ‘secret sauce’ of the DenerveX device that makes this procedure work.”
Prior to joining Medovex four years ago, Kullmann served as senior director of Medtronic’s $2.3-billion Cardiovascular Division. In addition, he has served in various leadership positions at Boston Scientific, Baxter, Johnson & Johnson, and five prior start-up medical device companies. He also wrote the book The Inventor’s Guide for Medical Technology.
Denerving Is Not Unnerving
The DenerveX device, in combination with the DenerveX Pro-40 Generator unit, is intended for ablation of soft tissues in spinal applications for selective denervation, which may be performed on the lumbar, thoracic, and cervical regions (C2-C7) of the peripheral nerves and nerve roots for the relief of pain associated with Facet Joint Syndrome. Typically, a patient will have four to six facet joints that are affected. You can watch a 3D animated video of the procedure and the DenerveX in action on the Medovex web site.
The procedure is performed with the patient under sedation. Using fluoroscopy — a type of moving X-ray guidance — the affected facet joints are identified, and then a small incision of 10-15 mm is made. Through this incision, a small procedural portal tube of 1 cm in diameter is inserted through the skin to the joint. Through this procedural portal tube, the DenerveX device is inserted, down to the facet joint, and activated. The DenerveX device uses both high heat and light tissue-scraping action simultaneously on the back of the facet joint to disrupt the pain signals carried by a nerve and receptors on the joint tissue capsule. Once the pain signal has been disrupted, a significant reduction in pain is expected. Recovery time after the procedure typically is one to two weeks.
I certainly understand the effect of stopping the patient’s back pain by removing the nerve, but I couldn’t help but wonder if that nerve served some other useful function that would be negatively impacted by its removal. Kullmann assured me that “there are no known consequences of taking out the nerve.”
The Path Of Least Resistance
I asked Kullmann about Medovex’s strategy to pursue the European market first.
“Many medtech companies go to Europe — first, if they perceive that the market is large (which it is for DenerveX), and secondly, if the European pathway is a little less onerous than coming to the United States,” he said, noting that the device has received CE Mark approval. “We’ll take data obtained in Europe and use that as a supporting piece of the IDE and a US clinical trial and will submit to the FDA. We will have to do a trial in the United States, and we have a clearly defined pathway already outlined with the FDA.”
When prodded for an indication of how adoption is proceeding in Europe, Kullmann responded, “Excellent, I couldn’t be happier; the reception of the technology has exceeded my expectation.”
Quality Lifestyles
The foundational work of Dr. Haufe, coupled with the DenerveX system’s CE Mark approval and excellent initial adoption in the European market, all are positive signs for Medovex. “We like to think that Medovex is in the lifestyle-changing business, not the life-saving business. Our technology doesn’t save lives, but it saves lifestyles,” Kullmann concluded.