Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Caldera Medical Announces FDA Clearance for New Desara® TVez for Stress Urinary Incontinence
Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products. Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products. Read more.
Source: Business Wire, December 2, 2021
Individual Pessaries For More Successful Treatment Of Stress Incontinence Through 3D Printing
Simply Standing up, doing sports, or just laughing, it’s extremely unpleasant whenever urine suddenly leaks uncontrollably. Colloquially referred to as a ‘weak bladder’, it’s known as Stress Urinary Incontinence in medical terms. Although about one in three women suffers from uncontrolled urine leakage, incontinence is still taboo. Initially merely a physical problem, it also quickly weighs on the soul. For fear of unpleasant situations, those affected often withdraw and avoid social activities with families and friends. 3D printed pessaries may relieve the burden. Read more.
Source: The Science Times, November 14, 2021
Let’s talk: Post-acute rehab patients need to be looped in about incontinence care, study finds
Post-acute care nurses are right on target with continence assessment and management, a new study finds. But their patients are largely unaware of these activities and think they’re going it alone, investigators say. The researchers conducted interviews with 10 nursing staff and 10 patients in two geriatric units of a rehabilitation hospital. Perhaps not surprisingly, nurses and patients had very different experiences of incontinence care. Read more.
Source: Urology Times, November 12, 2021
Study Finds Vibegron Has No Adverse Ambulatory Effects in Patients with OAB
It is important for clinicians to perform ambulatory blood pressure monitoring (ABPM) for patients taking new prescribed medications, as they may affect blood pressure or heart rate in detrimental ways. It is especially important to monitor patients with overactive bladder (OAB), as this group has an increasing abundance of novel medicines available to them. In a recent study presented at the 2021 American Urological Association Annual Meeting,¹ Michael A. Weber, MD, and co-authors assessed the blood pressure and heart rate profiles of the beta 3 adrenergic receptor agonist vibegron (Gemtesa) in treating patients with OAB. Read more.
Source: Urology Times, November 5 2021
Principle Business Enterprises and Elizabeth Dole Foundation Provide Relief for Hundreds of Veterans, Family Caregivers
Principle Business Enterprises, Inc., (PBE), which manufactures Tranquility® superabsorbent products, and the Elizabeth Dole Foundation, a prominent military Caregivers advocacy group, have partnered to provide Veterans and their families free in-home help. Their joint campaign themed “Relief and Freedom for Veteran Caregivers” encourages Caregivers of wounded, ill or injured service members to apply for free respite support and, for those with absorbent product needs, a customized incontinence care kit at TranquilityProducts.com/Respite. Read more.
Source: PRNewswire, November 1, 2021
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