State-backed Fund Boosts Monroe Company’s Elitone Medical Device

A Connecticut venture fund is backing a Monroe startup that is seeking Food and Drug Administration approval of a device to help alleviate a urological disorder affecting millions of women. In April, Newtown residents Gloria and Eric Kolb won U.S. patent protection on Monroe-based Elidah’s Elitone device to help women with stress urinary incontinence, with the Elitone device emitting mild electric impulses to stimulate and strengthen pelvic muscles. Women diagnosed with the condition can suffer urinary leakage during physical exertion or while coughing or sneezing. To date, physicians have recommended solutions ranging from exercises to surgical implants called pelvic meshes, with thousands of lawsuits having been filed against three manufacturers of the devices the past few years after women suffered adverse reactions. Read more.

Source: ctpost, August 17, 2017

Lab-engineered Tissue Is Creating New Digestive Tract Treatments

Wake Forest Baptist Medical Center have reported success with lab-engineered tissue replacements to treat digestive system diseases. The research team demonstrated the effectiveness of growing anal sphincters in a lab to treat an animal model for fecal incontinence. The success comes after the researchers reported success in implanting human-engineered intestines in rodents. “Results from both projects are promising and exciting,” said Khalil N. Bitar, senior researcher on both projects, in a press release. “Our goal is to use a patient’s own cells to engineer replacement tissue in the lab for devastating conditions that affect the digestive system.” Read more.

Source: Medical Design & Outsourcing, August 10, 2017

Common Drugs Hike Death Risks By 31%

A class of medications commonly prescribed to seniors for conditions such as urinary incontinence might increase the risk of mortality among nursing home residents with depression, a recently published study shows. Anticholinergic drugs have previously been found to increase emergency department and hospital visits for seniors, but little research had been done on the link between the drugs’ use and mortality among nursing home residents, researchers from the University of Houston said. Their study, published in June in Drugs & Aging, used nearly 45,000 residents’ Minimum Data Set information. The residents included in the study were prescribed “clinically significant” anticholinergic medications and had previously been diagnosed with depression. Read more.

Source: McKnight’s, August 9, 2017

Prostate Operation That’s Done Via Your WRIST Can Cut Threat of Incontinence

THE PATIENT. About eight years ago, I started needing the loo frequently at night. I put up with it at first, but it gradually got worse — at one point I needed to go five or six times a night. My GP told me to avoid alcohol and caffeine as these irritate the bladder, but this didn’t make a great difference and my symptoms continued to worsen. By last year, I was getting up for the loo in the night so often it left me feeling tired during the day. My GP suspected I had an enlarged prostate so referred me to a urologist. A few weeks later, I underwent various tests, including one where a machine measures the speed of your urine flow. Read more.

Source: Daily Mail, August 7, 2017

surgeons perform pelvic organ prolapse surgery

Women Damaged by Surgical Mesh to Treat Incontinence Are Furious at Report

Women damaged by surgical mesh used to treat post-childbirth incontinence have reacted with fury to a Government report investigating the problem. At least 7,800 women say they’ve suffered lacerations and nerve damage because the mesh has broken into tiny fragments. The report, which is unpublished but has been seen by Good Health, is the result of a three-year investigation by NHS England. It confirms that many more women have complained of injuries than previously suggested and calls for a helpline to support victims. But it did not look at the safety of the mesh and rejects calls for a ban. Instead, it says hospitals should ensure that surgeons be trained to implant it; at the moment any gynaecologist can perform the procedure. Read more.

Source: Daily Mail, July 25, 2017

ConvaTec Announces the Acquisition of Woodbury Holdings in the US

ConvaTec Group Plc (“ConvaTec”), a leading global medical products and technologies company, has agreed to acquire Woodbury Holdings (“Woodbury” or “The Company”), a US-based independent national distributor of incontinence and catheter-related supplies, from MTS Health Investors LLC for an enterprise value of $120.5 million. Woodbury provides an extensive array of incontinence and catheter products, as well as nutritional, enteral feeding and vascular compression supplies. The Company has national distribution across the U.S., delivering directly to customers in the home environment. With this acquisition ConvaTec Americas will create a new home distribution business unit for catheter and incontinence related products, encapsulating the U.S. distribution companies of 180 Medical, Symbius Medical, South Shore Medical Supply, Wilmington Medical Supply and Woodbury Health Products. Read more.

Source: PRNewswire, July 20, 2017

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