Bowel leakage, the need for anal incontinence protection and a restricted social life may cause severe, decades-long suffering among women with obstetric injuries to the anal opening, according to a study from the University of Gothenburg. The study, published in the American Journal of Obstetrics and Gynecology, comprises a total of more than 11,000 women who had given birth vaginally in Sweden, twice, in the years 1987-2000. Read more.
Source: Science Daily, February 23, 2023
Cellf BIO, a biotechnology company that manufactures bioengineered sphincters using autologous progenitor cells, announced today that it has begun its Phase 1 clinical trial for its BioSphincter™ Implant for the treatment of severe passive fecal incontinence (FI). The FDA cleared the company’s Investigational New Drug (IND) application, and the Institutional Review Board (IRB) approved the trial to begin enrolling participants. Read more.
Source: Globe Newswire, January 5, 2023
Incontinence-associated dermatitis (IAD) is a form of dermatitis caused by irritants that develop from chronic exposure to urine or liquid feces. Incontinence-associated dermatitis (MASD) consists of one of four types of moisture-associated skin damage. Moisture-associated skin damage has been defined as gradual inflammation and skin erosion resulting from prolonged exposure to several sources of moisture, including perspiration, wound exudate, mucus, saliva, urine, or feces. Read more.
Source: News-medical.net, September 28,2022
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.
Source: PRNewswire, February 22, 2022
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
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
A Stewartville firm, which makes medical devices to control fecal incontinence, took a major step forward this week with a deal to bring its products to European markets. Minnesota Medical Technologies, founded in 2015 under the leadership of Jim and Philip Conway, has signed an agreement with Sweden-based Wellspect Healthcare to distribute Minnesota Medical’s fecal incontinence insert throughout Europe. The myMiracle device is made of soft silicone, with a bulb that encapsulates liquid, so the insert conforms to the patient’s body for comfort and to create a seal. A typical patient might use about 500 of the one-time-use products a year. Read more.
Source: Post Bulletin, February 25, 2021
Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life. Read more.
Source: Medgadget, January 13, 2020
Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence. Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia. Read more.
Source: Medgadget, January 8, 2020
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia. The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term. Read more.
Source: Business Wire, September 9, 2019