Category Archives: Medical Devices

New Study Shows Spinal Cord Stimulation Reduces Opioid Use For Chronic Pain

ONE YEAR AFTER IMPLANT, 93 PERCENT OF PATIENTS WHO CONTINUED SCS THERAPY HAD LOWER AVERAGE DAILY MORPHINE-EQUIVALENT DOSES THAN PATIENTS WHO HAD THEIR SCS SYSTEM REMOVED

spine-25870_1280-geralt-free-use-cc0-pixabay

Image courtesy of geralt CC0 PIXABAY

New research has found spinal cord stimulation (SCS) therapy can be key to reducing or stabilizing the use of opioids in patients battling chronic pain. In a new study, researchers examined opioid usage data from more than 5,400 patients both prior to and after receiving an SCS system implant. In an SCS system, an implanted device similar to a pacemaker delivers low levels of electrical energy to nerve fibers, interrupting pain signals as they travel to the brain to reduce the sensation of pain. Researchers have found that average daily opioid use declined or stabilized for patients receiving a successful SCS system compared to patient use of opioids prior to an implant.

In addition, while opioid usage was not different for the two groups at time of implant, patients who underwent a successful SCS implant had significantly lower opioid use one year after their implant. Patients who had their SCS system removed saw their opioid use increase again over time.

In 5,400-patient study, average daily opioid use declined or stabilized in patients receiving SCS system, while patients who had SCS system removed had higher opioid use over time.  The study, which the researchers believe makes a compelling case for considering SCS therapy earlier in the chronic pain care continuum, were presented at the 2017 North American Neuromodulation Society (NANS) annual meeting by Ashwini Sharan, M.D., director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience at Jefferson and president of NANS.  The study was sponsored by Abbott (NYSE: ABT), a global leader in the development and manufacture of SCS systems and therapy options, such as the company’s proprietary BurstDR™ stimulation.

Currently, more than 2.1 million people in the U.S. suffer from substance abuse related to opioid pain relievers, while worldwide an estimated 15.5 million people are now classified as opioid dependent. Chronic pain is often a driver of opioid use as patients seek relief and improvements to their quality of life. Fortunately for patients, SCS therapy has been clinically proven to offer meaningful relief to patients suffering from chronic pain.  There is potential to improve outcomes by implanting SCS systems earlier, before chronic opioid use, according to authors.

“Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain,” said Sharan. “Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur.”

ABOUT THE STUDY:
For their analysis, the research team assessed private and Medicare insurance claims data from 5,476 patients who received an SCS system to treat chronic pain associated with a host of conditions (excluding pain related to cancer). The data were collected between January 2010 and December 2014. The data confirmed that many patients are often prescribed increasing dosages of opioids prior to receiving an SCS system. The researchers also found:
• SCS therapy is effective for patients at any level of opioid usage prior to implantation.
• Opioid use declined or stabilized in 70 percent of patients who received an SCS system.
• Among patients who had their SCS system explanted, opioid use was higher at one year compared to those who continued with SCS therapy.

The researchers further suggested patient outcomes could be improved if SCS were implanted earlier in recognition of the clinical practice to provide increasing dosages of opioids over time. These conclusions help build upon prior research, such as results of a large multicenter randomized controlled trial in patients with failed back surgery syndrome (FBSS) that showed trends in opioid reduction or cessation among SCS patients. In addition, new technologies released in the U.S. in 2015 and 2016 hold promise to improve outcomes further and may reduce common complications resulting in explant such as the undesired changes in paresthesia, issues with charging, pain at the implantable pulse generator (IPG) site, and loss of pain relief.

SOURCE: Displayed with permission from PRNewswire for Journalists

Scientist Helps NASA Develop Medical Device

In the future, NASA astronauts journeying into deep space may give themselves a health check-up with the aid of a small medical device developed by a team of scientists, including one from LLNL.

Laboratory radiobiologist Matt Coleman is part of the six-scientist team, including researchers from NASA’s Ames Research Center, the University of California, Davis and Sandia National Laboratories/California, that has developed a small, portable medical diagnosis instrument. The team members have filed for a patent for their medical device.

NASA MColeman Med Device

Radiobiologist Matt Coleman displays a device like the medical diagnosis instrument he helped develop for NASA for use in deep space. | Photo by Lawrence Livermore National Laboratory.

The patent covers the development of a comprehensive in-flight medical diagnostic system in a hand-held format weighing less than one pound for human deep-space missions such as a mission to Mars, which is expected to take six months each way.

 

 

 

“The point of developing tools like this one is for detecting disease from long-term exposure to microgravity and ionizing radiation,” Coleman said, adding that exposures from space exploration can potentially cause degenerative diseases of the bone, heart and eye, along with raising concerns about cancer.  “Since we don’t fully understand the long-term impacts of space travel, there has been a push by NASA to better understand these effects.”

The new medical device will use biomarkers in three different sample types – breath, saliva and blood – to detect information that is indicative of health and exposure to radiation. (A biomarker is any protein, DNA, RNA or small molecules that provide information about current or future health status).

Breath and saliva are non-invasive samples and can rapidly provide health assessment information, which can be critical immediately following space walks, and prior to removal of any spacesuits.

Key features of the device include the ability to handle multiple sample types and the ability to measure virtually any biomarker, including future biomarkers as they emerge. Small blood samples can provide information about macromolecular biomarkers as well as blood cell counts.  “Some of the tools we’re developing will be among the first multi-function health diagnostic devices used in space,” Coleman said.

The team conceptualized the device in 2012 and wrote a paper about its development that appeared in 2013 in the journal, Recent Patents in Space Technology. The team has built a conceptual mock-up of the portable medical device and its individual technologies have been tested.

The team’s lead scientist is Tore Straume of NASA’s Ames Research Center, a former LLNL researcher and Lab retiree. Straume is a radiobiologist, conducting research that focuses on the effects of ionizing radiation on human health. In addition to Coleman and Straume, the team includes David Loftus and Jing Li of NASA Ames, Cristina Davis of UC Davis and Anup Singh of Sandia National Laboratories/California.

By Stephen Wampler | Lawrence Livermore National Laboratory; Displayed with permission from Breaking Energy

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Ophthalmology Devices Global Market Forecast (to 2021)

Ophthalmology is a segment of medical science associated with study of anatomy, physiology, diseases of human eye, and developing various therapeutic methods to treat eye diseases.

SUMMARY:  Some of the major eye diseases are either age-related or caused due to chronic disorders. They include various degenerative eye diseases like macular degeneration, cataract, ocular hypertension (glaucoma), and refractive errors among others. Revolution in the field of medical science has led to the rapid development of ophthalmology devices that are invented to effectively treat ocular defects and disorders.

Ophth Devices REPORTOphthalmology devices market is segmented on the basis of products type as diagnostic devices, surgical devices and vision care. Based on the applications the ophthalmology devices market is segmented into cataract, glaucoma, age-related macular degeneration, diabetes retinopathy and others (refractive errors, amblyopia, and strabismus). End-users are segmented into hospitals, academic and research laboratories, and others (private eye clinic and vision care outlets).

The global ophthalmology devices market is expected to grow at a CAGR of around 5.8% from 2015 to 2021. Increasing incidence of degenerative diseases of eyes, increasing baby boomer population, increase in R&D activities in ophthalmology key players and extensive use of high-end technologies involving use of software and computer aided devices and platforms in ophthalmology drives the market of ophthalmology devices market. Lack of ophthalmologists, economic slowdown and saturation of the market in developed countries are the factors hampering the market growth.  (Access the full report: http://www.reportlinker.com/p03086455-summary/view-report.html)

Lifestyle changes owing to increase in ocular cancer, diabetes and macular degeneration patients, early diagnosis and treatment of diseases, advancement of technology with its wide application areas shows that ophthalmology devices market has vast opportunities in the coming years.

North America accounts for the highest market share followed by Europe. Steep rise in aging population, increase in minimally invasive surgeries and favorable government policies makes U.S. the leader of ophthalmology devices market. However, Asian countries especially India and China’s are the fast growing regions with its growing demand for ophthalmology devices and increasing research investments.

Major players in ophthalmology devices market include: Abbott Medical Optics, Inc. (USA), Alcon Laboratories, Inc. (USA), Bausch & Lomb, Inc. (USA), Carl Zeiss (Germany), Essilor International SA (USA), Haag-Streit Holding AG (Switzerland), Hoya Corporation (Japan), Nidek Co. Ltd (Japan), STAAR Surgicals (USA), Topcon Corporation (Japan).

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IUDs safe in population at high risk for STIs

  1.  In a study population at high-risk for sexually transmitted infections, the rate of pelvic inflammatory disease following intrauterine device placement was low.
  2. The IUD continuation rate at one year was greater than 85 percent.

Evidence Rating Level: 3 (Average)       

IUD Diagram Jun15 Blog

 

 

 

 

 

 

Image: CC/Wikimedia Commons/Blausen.com used with license/permission

Study Rundown: Intrauterine devices (IUDs) are some of the most effective forms of birth control, with a failure rate of less than one percent, and have been demonstrated to be safe for a wide range of women, including teenagers and young adults. Despite their high efficacy and safety record, many practitioners and patients still have misconceptions regarding the risk of pelvic inflammatory disease (PID) after IUD placement. PID is an infection of the upper genital tract (endometrium, tubes and ovaries) that commonly occurs when a sexually transmitted infection (STI), such as Chlamydia, gonorrhea, or trhichomonas ascends from the lower genital tract. Complications from PID include infertility and PID as well as an increased risk of ectopic pregnancy. If a woman has an STI at the time of IUD placement, she is at higher risk of contracting PID, but after about 20 days, the risk of PID decreases to the baseline risk among women who use a non-barrier form of contraception. Because of the concern for risk of PID with IUD insertion among women at high risk for STIs, most large studies exclude this population and limited data exists to guide their use in this population. In the present work, researchers retrospectively assessed rates of PID after IUD placement in an urban teaching hospital that did not restrict IUD eligibility based on STI risk factors.

Rates of PID following IUD placement were low and comparable to previous studies. The study population was at high-risk for STIs with a high incidence (nearly 50%) of personal history of STIs, 50% of participants were under the age of 26, and participants identified as being single. Lack of control group limited this study. Replication of findings using an age-matched control cohort would lend credence to the results presented herein.

Click to read the study in Contraception

Relevant Reading: Does insertion and use of an intrauterine device increase the risk of pelvic inflammatory disease among women with sexually transmitted infection? A systematic review

In-Depth [retrospective cohort]: Researchers reviewed charts of all patients undergoing hormonal IUD placement in the resident clinic of a large, urban, academic medical center from July 2007-June 2008 (n = 283). IUD candidates were not restricted by age, parity or STI risk. The primary outcome was diagnosis of PID within twelve months of IUD placement. Secondary outcomes included continuation and adverse outcomes: expulsion, perforation, pregnancy, pain and heavy bleeding.

Prior to IUD placement, 140 patients (49.5%) reported a history of STI and eight (3.02%) tested positive for gonorrhea or chlamydia at the time of placement in this high-risk population. In the 12 months following placement, only two patients (0.7%) were diagnosed with PID, one of which had a positive gonorrheal test at the time of placement. The continuation rate at one year was 85.2%, expulsion rate was low (5.3%) and a minority of women (17.7%) reported adverse effects.

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