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

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 weakness¹into 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.²These 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

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

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

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

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

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

Government Agrees to Temporarily Ban Vaginal Mesh Implants for Women with Urinary Incontinence

The [UK] government has accepted a recommendation to temporarily ban vaginal mesh implants for women with urinary incontinence. The Independent Medicines and Medical Devices Safety Review concluded there must be an immediate pause in the use of surgical mesh to treat stress-urinary incontinence (SUI) – a condition where urine leaks out when the bladder is under pressure. It comes after the National Institute for Health and Care Excellence (NICE) ruled last year against vaginal mesh as a treatment for pelvic organ collapse, but stated devices could still be used to treat SUI and to repair hernias in men or women. Read more.

Source: Independent, July 9, 2018

LABORIE Medical Technologies and Cogentix Medical Announce Completion of Acquisition

LABORIE Medical Technologies (“LABORIE”) and Cogentix Medical, Inc. (NASDAQ: CGNT) (“Cogentix”) today announced the completion of the acquisition by LABORIE of Cogentix through LABORIE’S affiliate Camden Merger Sub, Inc. (“Merger Sub”), a wholly owned subsidiary of LM US Parent, Inc. (“Parent”). After the previously announced completion of the tender offer for all of the outstanding shares of Cogentix, LABORIE completed the second step merger under Delaware law, resulting in Cogentix becoming a wholly owned subsidiary of Parent. At the effective time of the merger, all shares of Cogentix common stock not purchased in the tender offer (excluding those shares for which holders properly exercised appraisal rights under Delaware law and those held by Cogentix) were converted into the right to receive US$3.85, net to the seller in cash without interest thereon and subject to any required withholding tax, which is the same price that was paid for shares of Cogentix common stock purchased in the tender offer. Cogentix common stock will no longer be listed on the Nasdaq Capital Market or any other securities exchange. Read more.

Source: The Virginian-Pilot, April 23, 2018