Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
FDA Grants Breakthrough Device Designation to leva System for Chronic Fecal Incontinence
The FDA has granted a breakthrough device designation to the leva Digital Therapeutic System for use as a first-line treatment in women with chronic fecal incontinence (FI) in women, according to Renovia, the developer of the device. The breakthrough device designation will expedite the development and regulatory review of this treatment system in female patients with FI. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device. Read more.
Source: Urology Times, November 1, 2021
Stewartville Plant Creates New Solution to an Old Problem
Automated machines quietly raise and lower trays of liquid silicone, water and a paraffin-like material in a Stewartville facility to create a new solution to an age-old medical condition that afflicts an estimated 2 percent of the world’s population. Multiple, carefully monitored dips create trays of 400 silicone inserts with a small bubble of liquid in four minutes. The inserts then move on to packaging to eventually be shipped to Minnesota Medical Technologies’ waiting customers in a growing number of countries. Designed by and created by a local team led by brothers Jim and Philip Conway, the patented myMiracle device is a small, lubricated anal insert to be used as a simple and discreet way to treat fecal incontinence. Read more.
Source: Post-Bulletin, Rochester, Minn., August 7, 2021
Bladder-on-a-Chip and Bladder Organoids Reveal Dynamics of UTIs
Researchers at the Ecole Polytechnique Fédérale de Lausanne in Switzerland developed two complementary benchtop bladder models that could help in understanding the mechanisms behind recurring urinary tract infections (UTIs). The first involves bladder organoids, which allow the researchers to study bacterial-bladder cell interactions under realistic conditions, which include the 3D multi-layered architecture of the bladder wall. The second is a bladder-on-a-chip, which includes additional features that mimic the bladder environment, including the mechanical effects of bladder filling and voiding and bladder vasculature. Read more.
Source: Medgadget, August 3, 2021
Tibial Nerve Stimulator Is Safe, Effective, and Durable, 12-month Data Indicate
A nickel-sized tibial nerve stimulator offers overactive bladder (OAB) patients with urgency urinary incontinence long-term outcomes comparable to other treatment options, including percutaneous tibial nerve stimulation. Findings of a study published in Urology1 imply OAB treatment with the investigational eCoin (Valencia Technologies Corp) device is safe and achieves a durable response, says the study’s lead author, urologist Peter Gilling, MD, of Tauranga Urology Research Ltd, Tauranga, New Zealand. Read more.
Source: Urology Times, July 15, 2021
New App Supports Nurses to Provide Bladder and Bowel Continence Care
A free app that could boost nurses’ success in managing patients with bladder or bowel incontinence was launched on Monday, marking the beginning of World Continence Week. Those behind the new app said it was a result of a “genuine desire to help people with bladder and bowel symptoms access information and advice that can help”. The CONfidence app offers information, self-care tips and links to local health and support services for the estimated 14 million people in the UK with bladder control problems, and the 6.5 million who have bowel control problems. Read more.
Source: Nursing Times, June 22, 2021
Santex SPA Announces Acquisition of U.S. E-commerce Retailer Parentgiving, Inc.
Santex SPA, a global leader in premier incontinence products and surgical dressing and orthopedic products, announced the acquisition of Parentgiving, Inc., the country’s premier retailer of caregiving products for the aging. The agreement was finalized in June 2020, and the companies have spent the past year integrating operations and developing an expanded portfolio of Parentgiving’s signature Dry Direct incontinence products for expansion in the United States. Read more.
Source: PR Newswire, June 22, 2021
FDA Authorizes Study Exploring Novel Device for Bladder Incontinence
The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence. The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.
Source: Urology Times, April 27, 2021