Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
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
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
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
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
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 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 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