February 21, 2018

FEB 14, 2018

With three Episealer® knee implant products currently approved and on the market in Europe, Episurf Medical (NASDAQ: EPIS B) has initiated the development of a new line of personalised Episealer® implant products intended for osteochondral lesions of the talus bone in the ankle joint. Such lesions are a common and growing problem, along with few alternative treatment methods. Episurf Medical is now responding to a significant demand voiced by its network of surgeon partners. The ambition is to perform the first surgeries during Q2 2018.

The new ankle implant and associated surgical instruments are based on the same technology platform as the company’s Episealer® knee devices, with a patient-specific design based on medical imaging and 3D modelling.

Episurf Medical has previously delivered one custom-made implant solution for a patient in Germany with an ankle joint lesion. The ankle implant was custom-made to the surgeon’s specifications in a difficult case where a custom-made patient-specific implant was the only available solution. The surgeon saw no other reasonable treatment alternative, as there is no such implant on the market today. The surgery was performed in 2016. The surgery was successful and the patient reported excellent results at the 12 months’ clinical follow-up visit.

“An osteochondral ankle defect is a lesion of the talar cartilage and subchondral bone, which commonly causes deep and intractable ankle pain. These lesions are generally caused by a single or multiple traumatic events, often sport injuries. We are convinced that Episurf’s knee technology should adapt well to the ankle, and the 12-months’ data from Germany is very encouraging. The technical synergies, along with the lack of adequate techniques for treatment of this kind of ankle lesions, as well as careful market analysis, led us to the decision to pursue this new initiative. We look forward to providing the same kind of benefits to patients with ankle injuries as we today do to those with lesions in the knee,” comments Prof. Leif Ryd, Senior Medical Advisor to Episurf Medical.

“Adding additional products to our platform is an important part of our long-term strategy and the ankle implant brings a significant long-term revenue potential to Episurf Medical,” comments Pål Ryfors, CEO of Episurf Medical.

For more  information, please contact:

Pål Ryfors, CEO, Episurf Medical

Tel:+46 (0) 709 62 36 69

Email: pal.ryfors@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.55 CET on 14 February 2018.

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February 13, 2018

February 13, 2018

February 6, 2018 – Authors: Carl A. Deirmengian  MD  Joshua S. Dines, MD  Joseph V. Vernace MD Michael S. Schwartz MD MBA  R. Alexander Creighton MD James N. Gladstone MD

ABSTRACT

The use of arthroscopy for purely diagnostic purposes has been largely supplanted by noninvasive technologies, such as magnetic resonance imaging (MRI). The mi-eye^+TM (Trice Medical) technology is a small-bore needle unit for in-office arthroscopy. We conducted a pilot study comparing the mi-eye^+TM unit with MRI, using surgical arthroscopy as a gold-standard reference. We hypothesized that the mi-eye^+TM needle arthroscope, which can be used in an office setting, would be equivalent to MRI for the diagnosis of intra-articular pathology of the knee.

This prospective, multicenter, observational study was approved by the Institutional Review Board. There were 106 patients (53 males, 53 females) in the study. MRIs were interpreted by musculoskeletally trained radiologists. The study was conducted in the operating room using the mi-eye^+TM device. The mi-eye^{+ TM} device findings were compared with the MRI findings within individual pathologies, and a “per-patient” analysis was performed to compare the arthroscopic findings with those of the mi-eye^+TM and the MRI. Additionally, we identified all mi-eye^+TM findings and MRI findings that exactly matched the surgical arthroscopy findings.

The mi-eye^+TM demonstrated complete accuracy of all pathologies for 97 (91.5%) of the 106 patients included in the study, whereas MRI demonstrated complete accuracy for 65 patients (61.3%) (P < .0001). All discrepancies between mi-eye^+TM and arthroscopy were false-negative mi-eye^+TM results, as the mi-eye^+TM did not reveal some aspect of the knee’s pathology for 9 patients. The mi-eye^+TM was more sensitive than MRI in identifying meniscal tears (92.6% vs 77.8%; P = .0035) and more specific in diagnosing these tears (100% vs 41.7%; P < .0001).

The mi-eye^+TM device proved to be more sensitive and specific than MRI for intra-articular findings at time of knee arthroscopy. Certainly there are contraindications to using the mi-eye^+TM, and our results do not obviate the need for MRI, but our study did demonstrate that the mi-eye^+TM needle arthroscope can safely provide excellent visualization of intra-articular knee pathology.

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BALTIMORE, Feb. 7, 2018 /PRNewswire/ — DT MedTech, LLC (DTM) announced today that Prof. Beat Hintermann, world-renowned foot and ankle surgeon and developer of the new, two-component, semi-constrained total ankle prosthesis, Hintermann Series H2™ Total Ankle Replacement System, has successfully implanted five H2 devices in patients in Liestal, Switzerland. Four of the procedures were primary total ankle replacements and the fifth was a takedown of a mal-position arthrodesis.

The H2 Total Ankle Replacement System is indicated for use as a non-cemented implant outside of the United States and as a cemented implant within the United States, to replace painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis). The Hintermann Series H2™ can also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis.

Prof. Hintermann said, “I am extremely pleased with the outcomes of the recent H2 surgeries performed, especially as the patients were able to bear their own weight just 24 hours after the devices were implanted. Adding this semi-constrained option for my patients alongside the Hintermann Series H3™* mobile-bearing prosthesis, enables me to expand patient selection for total ankle replacements.”

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters in Raleigh, NC, and through specialized and select distributors. Sales and distribution outside of the United States will be handled through HealthLink Europe BV, from its Netherlands location, and other specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We anticipate a limited release of the Hintermann Series H2™ beginning in early February outside of the United States, and in late March within the United States. We have been focused on training, sales, and distribution of the Hintermann Series H2™ in markets around the world and are looking forward to a very successful launch.”

For additional DTM information inside the United States, please email info@DTMedTech.com or call Ms. Jeannie Sarda at +1 410-427-0003; outside the United States, please email dt-medtech@healthlinkeurope.com or call +31 73 303 2537.

About DT MedTech, LLC
DT MedTech, LLC is the parent company of DT MedTech International and European Foot Platform, S.A.R.L.  DTM and its subsidiary companies maintain offices in Baltimore, Maryland; Dublin, Ireland; Saint-Louis, France; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, marketing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series Total Ankle Replacement Systems.

*Please note: Hintermann Series H3™ is not available for sale within the United States and its territories.

SOURCE DT MedTech, LLC

January 31, 2018 – By Tiziano Marovino, DPT, MPH, DAIPM

About the Device

Product: OSKA Pulse, a pulsed electromagnetic field wearable device

Indication: This nonprescriptive, FDA-registered Medical Device Class 1 is manufacturer-
indicated for acute or persistent pain due to injury in the back, knee, muscles, and joints, or as a result of other pain-related conditions such as sciatica, plantar fasciitis, and carpal tunnel syndrome.
Application: The portable, self-managed device may be worn under or over clothing at the site of pain via velcro straps as a standalone or complement to physical therapy.
Specifications: 5.2” x 3.5” x 1.25”; 8 ounces

Price: $399.99

Manufacturer: OSKA Wellness, Carlsbad, CA

Noteworthy: Released in 2016, the OSKA Pulse received the 2017 Tech.Co Startup of the Year and has been successfully trialed among US Special Forces. View a double-blind study of the device.

Patient Sample & Trial Conditions

A mini trial was conducted at a free-standing outpatient chronic pain center in Ypsilanti, Michigan, where a multi-disciplinary approach is utilized to treat persistent pain. All participating subjects provided informed consent.

Patients (n = 26) tested the device over a period of five to six weeks. Participants exhibited with a range of conditions: low back pain conditions including degenerative disc disease, radiculopathy, facet syndrome, idiopathic low back pain, and spinal osteoarthritis; as well as cervical radiculopathy; whiplash; cervical spine osteoarthritis; facet joint fixation/subluxation; chondromalacia; osteoarthritis or arthrofibrosis of the knee; patellar subluxation syndrome; ankle sprain; plantar fasciitis; shoulder rotator-cuff syndrome; fibromyalgia; vasculitis; and chronic venous insufficiency.

The short-term trial included brief exposures to the device in the clinical setting, for approximately 30 minutes per day, twice a week. On average, patients used the device three to five times in total at the site of pain. Limited blinding was applied to those reporting pain relief. Testing also included effect on increased perfusion immediately post-treatment using an O2 biosensor at the capillary level.

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www.OskaWellness.comhttp://www.oskawellness.com?rfsn=501458.a6ae5 

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Photo Courtesy of OSKA Wellness

January 31, 2018 – By Joseph R. Shurman, MD, Brenda K Wiederhold, PhD, MBA, BCN, BCB , Roger Kasendorf, DO, John Qian, MD, Ian Miller and Mark D Wiederhold, MD, PhD, CPE, FACP, FACPE

Recently declared a nationwide public health emergency, the misuse and abuse of opioids in the United States takes the lives of more than 90 Americans every day.¹ The most recent report from the US Centers for Disease Control and Prevention (CDC) recounted more than 65,000 deaths from drug overdose over a 12-month period—a record high.² More alarming, however, is that drug overdose deaths have increased every year since 1999, mirroring a similar trend in increased opioid sales.^{3, 4} In fact, both the amount of prescription opioids sold and overdose deaths involving opioids have more than quadrupled since 1999.⁴ As one of the most commonly prescribed medications to the 100 million patients experiencing chronic pain in the United States annually, opioids are integral to many pain management practices.^{5 ,6} With the national spotlight increasingly focused on the hazards of opioid misuse, however, the time is now to find additional solutions that may assist in pain management.

While a plethora of addiction screening, education, and prevention programs have been instituted in pain management practices,^{7, 8} nonpharmacalogical treatment modalities have the potential to make chronic pain care safer. In response to the opioid crisis, one such program mandates that patients who need opioids for nonmalignant pain must first see a psychotherapist to assess suicide risk, and provide psychological support and stress reduction. In addition, these patients must also see an addictionologist to assess risk for addiction. Finally, this opioid safety model includes “non-drug” approaches to pain management, including exercise, physical therapy, and integrative medicine treatments.⁹ Overall, there are a wide range of chronic pain treatment strategies, including pulsed electromagnetic field (PEMF) therapy.

Clinical Efficacy of PEMF

Recent research identifies improvements in the treatment of chronic pain using PEMF therapy. Sutbeyaz et al.¹⁰ tested low-frequency PEMF therapy on 56 women with fibromyalgia. Random group assignment placed 28 women in a PEMF treatment group, while the 28-patient placebo group received a sham therapy. After receiving two 30-minute treatments per day for 3 weeks, researchers reported 52% reduction in life interference in the PEMF group, compared to 11% reduction in the sham group. Overall, participants in the PEMF group reported statistically significant reductions in pain.¹⁰

In an exploratory study of PEMF therapy’s effects on postoperative pain, Hedèn¹¹ also reports a three-fold decrease in subjective pain by the PEMF group compared to a placebo after only three days. Another study from 2014 evaluated the effects of PEMF and exercise on pain, muscle functioning, and muscle strength in patients with shoulder impingement syndrome (SIS).¹¹ These 56 patients, randomly assigned to a PEMF plus exercise condition or placebo plus exercise condition, completed a three-week trial. Results indicated significantly higher levels of functioning and reduced pain in the PEMF group. The PEMF group also exhibited greater strength.¹¹

The present study evaluates the effectiveness of PEMF therapy on chronic pain patients as part of a two-week double blind clinical trial with placebo using the OSKA Pulse PEMF device (OSKA Wellness, Carlsbad, CA).¹²

Methods

Participants. Thirty-nine patients (n = 39) with diagnosed chronic knee, shoulder, or back pain were enrolled in the study. To be included, participants were required to be older than 18 years of age, be capable of providing full informed consent, and had to have either chronic should, back, or knee pain. Participants were excluded from the study if they had vestibular disease, epilepsy, cancer, or a pacemaker. Nine patients withdrew throughout the trial for reasons including: lack of pain reduction, inability to follow the protocol, and difficulty using the device. Overall, 30 patients completed the trial.

Design. The trial used a between-subjects design to compare baseline to follow up change in pain between the two groups.

Materials. Each participant was provided a daily log to report their pain, stress, and daily use of the device. Pain and stress scores in daily log were based on a 10-point Likert scale (0 = no pain/stress, 10 = extreme pain/stress). Participants were sent home with either an OSKA Pulse or a sham device. The sham device looked and functioned the same as the actual device, but did not emit any PEMF waves.

Procedure.Both patients and investigators were blinded as to real or placebo OSKA device. Each participant was randomly assigned to either the OSKA Pulse group (n = 15) or placebo group (n = 15). At intake, after signing full informed consent, each participant was briefed on the protocol. For two weeks, participants used the PEM device or placebo while recording their pain, stress, and number of times using the device in a daily log. For the first seven days, all participants were instructed to use the device four to six times per day for 30 minutes at a time, recording their daily log scores around the same time (ie, after dinner, before bed). For the second week, participants were asked to use the device only two to four times per day for 30 minutes at a time, and record their pain, stress, and usage in the daily log.

Upon completion of the trial, participants returned their devices and daily logs to the clinical trial coordinator. The coordinator manually entered all data points into excel, using a data analysis package to run between-subjects one-tailed t-tests. Assuming no detrimental side effects of the PEMF device Pulse, the authors chose a one-tailed t-test to evaluate pain and stress scores. This one-directional test focuses on improvements in pain conditions.

READ THE REST HERE

www.OskaWellness.comhttp://www.oskawellness.com?rfsn=501458.a6ae5 

ADD COUPON CODE “ORTHOSPINECO” FOR $55.00 OFF

Photo Courtesy of OSKA Wellness

February 06, 2018