A 49 year old male initially presented with a 10 year history of bilateral heel pain and numbness. Tinel’s sign was positive over the tarsal tunnel. His ETF TVT (timed vibration test) at the hallux was 3.2s left, 5.2s right. The patient went on to fail conservative care and eventually had NCV/EMGs confirming tarsal tunnel syndrome bilaterally. The patient chose to undergo a tarsal tunnel release on the left foot as it was the more symptomatic. Post-op ETF TVT was 11.7s confirming improved large nerve fiber function. The patient noted a subjective restoration of sensation and 0/10 pain level at one month post-op.
Posterior Tibial Nerve viewed within the Tarsal Tunnel
*ETF clinical cases are presented to demonstrate the diagnostic utility of the ETF128. Cases are derived from actual ETF customer practices. Customers are encouraged to submit their own cases for future posts.
As our current customers know, the ETF has a Constant Mode setting calibrated to the same vibration output as the 25v level on the biothesiometer. This allows users to rapidly evaluate neurological status by reproducing an established vibration perception threshold (VPT) value for diabetic neuropathy testing at the hallux. The importance of this threshold value was again highlighted in a landmark study recently published in the New England Journal of Medicine. This article written by Drs. Armstrong, Boulton and Bus reviewed the current thinking on diabetic ulcers and their recurrence. In their review, the authors site an article by Monami et al. linking depression with slower ulcer healing rates in diabetics. The article also notes a 12.05 odds ratio for ulcer recurrence in diabetic patients with vibration perception thresholds >25v when combined with depressive symptoms. This finding supports the link between diabetic neuropathy, depression and ulcer recurrence again highlighting the need to integrate behavioral health into the medical mainstream.
Comments Off on ETF makes Podiatry Today’s Top Ten Innovations List
The company is pleased to announce the ETF’s selection as one of Podiatry Today’s Top Ten Innovations of 2014. “Inclusion in this list of emerging technological innovations is an unexpected honor, ” said company CEO, Todd O’Brien. “This is welcome recognition for our design team’s hard work especially as Podiatry Today is one of the most respected and widely read periodicals in the podiatry profession.”
The ETF, which has undergone three design iterations and a successful round of beta site testing, is currently scheduled for commercial launch in early 2015. Pre-orders are now being accepted for a limited pilot production run.
Comments Off on O’Brien Medical Awarded Patent for the ETF128
O’Brien Medical is pleased to announce that it has been granted patent #8,684,945 by the U.S. Patent and Trademark Office for its Electronic Tuning Fork, or ETF128. The device offers a significant improvement over current methods used by doctors for detecting diabetic peripheral neuropathy (DPN), which is a common precursor to diabetic limb loss.
“The ETF128 provides the medical profession with a notably improved method for diagnosing the degree of peripheral neuropathy in diabetic patients. With earlier detection and quantifiable testing results, this device will enable doctors to more rapidly implement preventive strategies that can reduce the occurrence of foot ulcers, infections and amputations,” said Dr. Todd O’Brien, president and founder of O’Brien Medical.
Neuropathy is a disorder of the peripheral nervous system that can cause pain, loss of sensation, weakness and paralysis of limbs. It is a common symptom of diabetes and often starts in the longest nerves in the body, namely those nerves at the tips of the toes.
For decades medical professions have used the traditional hand-held tuning fork along with other sensation tests to diagnose the onset of neuropathy in diabetic patients. While the tuning fork has proved to be a sensitive indicator of neuropathy, it has limitations in terms reproducibility and quantification of results. The ETF overcomes these shortcomings by transforming the tuning fork into a modern digital instrument calibrated to provide standardized, quantifiable results. The improved accuracy and reproducibility afforded by this approach gives physicians a reliable method of detecting and measuring peripheral neuropathy.
“One of the major downfalls of traditional tuning fork testing is variation in use between doctors. This fact, combined with a lack of standardization between tuning fork manufacturers results in imprecise results. The ETF is designed to overcome these limitations and provide doctors with a superior state-of-the-art diagnostic tool,” O’Brien stated.
Field testing of ETF beta prototypes began in July 2013 at academic medical centers, clinics and private practices across North America. These locations were chosen for their excellent reputations, resident specialists and high volumes of diabetic foot patients. Physicians testing the device generated strong positive feedback and provided insights on how to improve the design prior to commercial launch. A proof-of-concept study, published in the March 2014 edition of the Journal of the American Podiatric Medical Association(JAPMA), the world’s leading peer-reviewed podiatric publication, offers further evidence for the effectiveness of the ETF.
The development of the ETF began more than five years ago when O’Brien, a practicing doctor of podiatric medicine with a 20-year history of medical device invention and development, conceived of the idea. O’Brien first approached the Advanced Manufacturing Center at the University of Maine to develop a proof-of-concept ETF.
“The Electronic Tuning Fork is a great example of the kind of medical device R&D that’s occurring now in Maine,” said John Belding, director of the Advanced Manufacturing Center. “It turned out to be a very successful collaborative project for the AMC and University of Maine, and we’re pleased that O’Brien Medical has been awarded a patent for the instrument.”
O’Brien’s next step was to develop the beta and commercial versions of the device. This was accomplished through the combined efforts of Dr. Bruce Segee of UMaine’s Department of Electrical and Computer Engineering and Stephen Abbadessa, a mechanical engineer from the private sector. Segee, an enthusiastic supporter of UMaine’s role in local entrepreneurship, views the project as an illustration of how the University can help grow the Maine economy.
“This is the perfect example of how things should work” said Segee. “We have a physician who has been trained to diagnose neuropathy the same way that previous generations of doctors have done it, who says “I can improve on this”. With entrepreneurial assistance, seed capital, local expertise and assistance from the University of Maine, he’s started a company, field tested working units, and is well on his way to a major launch of a product that can literally make the world a better place.”
The National Institutes of Health reports that nearly 26 million Americans – 8.3 percent of the population – have diabetes. Of these, 7 million do not know that they have the disease. Diabetes is the seventh leading cause of death in the United States. The lack of early detection and awareness leads to a large number of preventable complications, including limb loss and premature death.
“More than half of diabetic patients develop neuropathy and a significant number suffer severe and permanent limb impairment,” O’Brien stated. “With earlier detection of neuropathy, physicians will be able to implement preventive strategies that can reduce the occurrence of ulcers and other consequences of neuropathy, thereby improving the quality of life of diabetic patients.”
The patent issued on the ETF further strengthens O’Brien Medical’s position as it ramps up for its pilot production run. A Maine electronics manufacturer has been selected to produce the device. O’Brien expects the device to be available for purchase in late 2014.
Comments Off on Proof-of-Concept ETF Study Published in JAPMA
O’Brien Medical is pleased to announce the publication of our ETF proof-of-concept study in the world’s premier podiatry journal, JAPMA. This clinical trial evaluated the efficacy of the ETF at detecting diabetic peripheral neuropathy (DPN) compared to current standard neurological screening tests. The ETF was found to be more sensitive at detecting neuropathy compared to traditional methods. These findings further support the concept of implementing the ETF as a standardized method of identifying and tracking the progression of DPN.