Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB
Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome. InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.
Source: MassDevice Today, July 17, 2017
Unique Method Trains Brain of Incontinence Patients
Czech experts have developed a unique method to help patients with urinary incontinence by teaching their brain to ignore false signals it receives from their hyperactive bladder, daily Hospodarske noviny (HN) wrote on Wednesday. The breakthrough method, together with a special device it uses, will facilitate the treatment of incontinence, the experts from Charles University’s 2nd Medical Faculty say. The device will be produced by the Tesla Medical company, which has gained 20 million crowns from small investors for this purpose, HN writes. Read more.
Source: Prague Daily Monitor, July 12, 2017.
Uromedica Wins CMS Coverage for ProAct Continence Therapy Device
Uromedica said today it won a reimbursement code from the Centers for Medicaid and Medicare Services for its ProAct adjustable continence therapy for men, and that it launched the device in the US. The ProAct system has FDA approval and is indicated for treating adult men with stress incontinence from intrinsic sphincter deficiency of at least 12 months following radical prostatectomy or TURP who have failed ot respond to conservative therapy, the Plymouth, Minn.-based company said. “The issuance of these codes will allow Uromedica to deliver its safe and effective therapy to improve the quality of life for men struggling with Stress Urinary Incontinence,” prez & CEO Tim Cook said in a press release. Read more.
Source: MassDevice Today, July 12, 2017
Recurring Intestinal Infections on the Rise in U.S.: Study
Recurring Clostridium difficile intestinal infections are rising sharply in the United States, researchers warn. These infections sicken about 500,000 people a year, cause tens of thousands of deaths, and cost the U.S. health care system about $5 billion, according to investigators at the University of Pennsylvania. C. difficile causes diarrhea, severe gut inflammation and can lead to deadly blood infections, especially in the elderly. A review of nationwide health insurance data found a nearly 200 percent increase in the annual incidence of multiple recurring C. difficile infections between 2001 and 2012. For ordinary C. difficile, incidence rose by about 40 percent. Patients with multiple recurring C. difficile infections tended to be older (average age 56 versus 49), female, and were more likely to have used antibiotics, corticosteroids or acid-reducing drugs, the findings showed. Read more.
Source: HealthDay News, July 7, 2017
Engineering Digestive System Tissues: Significant Progress
Researchers at Wake Forest Institute for Regenerative Medicine have reached important milestones in their quest to engineer replacement tissue in the lab to treat digestive system conditions — from infants born with too-short bowels to adults with inflammatory bowel disease, colon cancer, or fecal incontinence. Reporting today in Stem Cells Translational Medicine, the research team verified the effectiveness of lab-grown anal sphincters to treat a large animal model for fecal incontinence, an important step before advancing to studies in humans. And last month in Tissue Engineering, the team reported success implanting human-engineered intestines in rodents. Read more.
Source: Science Daily, July 5, 2017
Consider Acupuncture for Incontinence
Acupuncture, a 3,000-year-old healing technique, received mixed reviews in two new studies from China — one focusing on incontinence and the other on a cause of female infertility. A research team found acupuncture did improve symptoms of stress incontinence — an involuntarily loss of urine, such as when a woman sneezes or coughs. But in a separate study, another team of researchers determined that acupuncture did not help women who were infertile because of polycystic ovary syndrome (PCOS). Women with PCOS have a hormonal imbalance that keeps them from releasing an egg (ovulating) during the menstrual cycle. Read more.
Source: HealthDay News, June 27, 2017
RDD Pharma Receives Orphan Designation for RDD-0315 in Spinal Cord Injury Patients
RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency’s Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury. The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence. “We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma. ‘We have the potential to positively impact the health, well-being and quality of life in this patient population. ‘ Read more.
Source: PRNewswire, July 5, 2017