clinical medical

Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence

Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.

Source: BioSpace, July 7, 2020

exercise women

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.

Source: Yahoo Finance!, March 4, 2020

product approval introduction

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.

Source: Yahoo! Finance, February 6, 2020

product approval introduction

Contura Nabs FDA Nod for Female Incontinence Device

Contura has earned FDA approval for an injectable hydrogel [Bulkamid] to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine.  Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms. Read more.

Source: MedTechDive, February 4, 2020

women friends

Viveve Medical (VIVE) Announces Authorization to Initiate Short-Term Feasibility Study in Stress Urinary Incontinence from Canadian Ministry of Health

Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. Read more.

Source: Street Insider, December 18, 2019

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

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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