ELITONE

Elidah Announces the Launch of ELITONE® – A New Non-Invasive Treatment for Women’s Incontinence

Elidah, Inc (https://elitone.com/), a woman-owned medical device company, today announced the launch of ELITONE®, the first and only patented medical device providing non-invasive treatment for stress urinary incontinence in women. ELITONE is the first product of its kind launched under a newly created FDA product category for non-invasive incontinence therapy. Stress urinary incontinence is the loss of bladder control when activities such as exercising, coughing, laughing or sneezing increase the internal pressure placed on the abdominal cavity and pelvic floor muscles. Read more.

Source: PRNewswire, August 20, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Study Shows Advantages for Stress Urinary Incontinence Surgery

One of the most commonly performed surgeries to treat stress urinary incontinence in women may have better long-term results than another common surgical technique, according to a study led by Mayo Clinic researchers.  The retrospective study of more than 1,800 cases at Mayo Clinic from 2002 to 2012 found that the need for additional surgery was twice as high after a transobturator sling surgery compared with a retropubic sling procedure. Reoperation rates within eight years after surgery were 11.2 percent for patients in the transobturator group compared with 5.2 percent in the retropubic group, according to the study, which will be published in the journal Obstetrics and Gynecology in August. Read more.

Source: Austin Daily Herald, July 16, 2019

business buildings

Rinovum Women’s Health Debuts Revolutionary Reusable Over-the-Counter Product Clinically Proven To Treat Light Bladder Leaks and Boost Women’s Confidence

Rinovum Women’s Health, the makers of the successful Stork® products for at-home conception has debuted a breakthrough reusable device, clinically proven to treat light bladder leaks that does not require a prescription, impacting the more than 15 million women in the U.S. who suffer from the embarrassing issue. The revolutionary product Revive™ is an FDA-cleared urethral support device designed to empower women and help them to take charge of their health by kicking stress urinary incontinence (SUI) to the curb. After successfully growing The Stork ®OTC, the first conception aid sold over-the-counter, Rinovum Women’s Health has made Revive available in nearly 5,000 retail locations nationwide and growing. Read more.

Source: BioSpace, June 24, 2019

INNOVO

1-In-3 Women In America Can Now Proudly Declare “I Just Free’d Myself With INNOVO®” Thanks To Revolutionary New Device To Treat Root Cause Of Bladder Weakness

“OMG. I just free’d myself!” Today, 20 million women in America will rewrite that whispered, uncomfortable admission of bladder weaknessinto a declarative, celebratory shout thanks to INNOVO®. As the first-in-class wearable, non-invasive solution for Stress Urinary Incontinence (SUI), INNOVO has the potential to positively impact the lives of one in three women.These women will now be able to laugh louder, exercise harder and even sneeze with ease. The INNOVO thigh-length, elasticized therapeutic shorts are outfitted with eight electrodes sewn in a crisscross formation across the pelvic region. When activated via its attached hand-held controller, INNOVO delivers a series of pelvic stimulations equivalent to Kegel exercises for strengthening the pelvic floor. Read more.

Source: PRNewswire, June 5, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

BD withdraws surgical mesh products for SUI and POP

A spokesperson said: “BD has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide. While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements.”  The government website says there is no need for implanted devices to be removed and no additional follow-up is required for patients implanted with such devices but anyone who has any concerns about their implanted device should contact their GP. Read more.

Source: Medical Plastics News, March 7, 2019

operating room surgery

Tepha Initiates Clinical Evaluation of P4HB Regenerative Scaffold for Stress Urinary Incontinence

Tepha has announced the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI).  The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa(“PFFSA”) and the University of Cape Town.  The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands.  The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology.  Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure. Read more.

Source: Compelo, February 28, 2019

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InControl Medical Introduces Attain at CES 2019

InControl Medical is proud to announce that Attain, the most advanced over-the-counter device available to treat male and female incontinence and the logical first choice for treatment, will be shown at the 2019 Consumer Electronics Show (CES, January 8-11, Las Vegas Sands, Halls A-D – 43569). According to Herschel “Buzz” Peddicord, InControl’s founder and CEO, “This revolutionary medical device is designed to help treat the approximately 87 million people in the U.S. suffering with stress, urge, or mixed urinary incontinence, and/or bowel incontinence. Attain provides muscle stimulation, visual biofeedback, and a guided exercise program to solve incontinence at the source — the muscle level. Attain’s regular self-treatment program, in the privacy of one’s home, eliminates the need for pads, meds, surgery or diapers.” Read more.

Source: Business Wire, January 8, 2019

women exercising

FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females.  Read more.

Source: Business Wire, November 13, 2018

hormones change as women age

Renovia Launches “REDUCE” – a Multi-Center Randomized Controlled Trial to Study Next-Generation leva® Pelvic Digital Therapeutic System for Urinary Incontinence

Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI). Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging. Read more.

Source: Business Wire, November 12, 2018

doctor male discussion

Most Transient SUI After HoLEP Resolves Within 6 Weeks

Most men who experience transient stress urinary incontinence (SUI) following holmium laser enucleation of the prostate (HoLEP) recover full bladder control within the first 6 weeks after the procedure, according to study findings presented at the International Continence Society’s 2018 annual meeting.  In addition, the study identified prostate size larger than 100 g and catheter dependency prior to HoLEP, and longer operative time as risk factors for transient SUI.  A retrospective review of 515 patients who underwent HoLEP showed that 53 (10.3%) experienced transient SUI, Jenny Guo, BS, and colleagues at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, reported. Transient SUI resolved within the first 6 weeks post-operatively in 47 (88.6%) of these patients and within 6 week to 3 months in 6 patients (11.3%). Read more.

Source: Renal and Urology News, August 30, 2018