Missed Opportunities For the One In Five With Anal Incontinence After Childbirth

Researchers are calling for improved care and more awareness of injuries that leave over one in five of those giving birth with anal incontinence. Over one in five women will develop anal incontinence in the first five years after having a vaginal birth. Anal incontinence is common and usually caused by trauma to the pelvic floor, nerve damage and anal sphincter injuries. The timing of symptom onset varies; some women experience anal incontinence onset soon after childbirth (which may or may not resolve), while many develop worsening or new symptoms during the menopause. The University of Warwick-led study, with input from the MASIC Foundation (a national charity to support women who have suffered severe injuries during childbirth), identified missed opportunities in getting a diagnosis of anal incontinence, an absence of clear pathways for those who are referred for treatment, and a lack of awareness of the problem among health care professionals and those who have given birth. Read more.

Source: MedicalXpress, June 28, 2023

Decades-Long Suffering From Obstetric Injuries

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 Begins Phase 1 Clinical Trial of BioSphincter™ Implant for Fecal Incontinence

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

What is Incontinence-Associated Dermatitis?

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 Receives FDA Approval for InterStim X™ System

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

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

Stewartville Medical Device Maker Lands big European Deal

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

Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study. Read more.

Source: Business Wire, September 10, 2020

InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

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