product approval introduction

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

e. coli bacteria

Smartphone Camera Test for Urinary Tract Infections

Researchers at the University of Bath have developed a simple point-of-care test for urinary tract infections that uses a smartphone camera. The system can rapidly detect the presence of E. coli in urine samples and could guide doctors in their decision to prescribe antibiotics, ensuring appropriate patient care and avoiding the overuse of antimicrobial medication.  It can sometimes be difficult for clinicians to know whether to prescribe antibiotics. Unnecessary use of antibiotics is resulting in antimicrobial resistance, which will pose significant challenges to healthcare in the coming years. However, if a patient has an infection, such as a urinary tract infection (UTI), then antibiotics are undoubtedly warranted, but it can sometimes be difficult for a clinician to know for sure if a patient’s symptoms are caused by an infection. Read more.

Source: Medgadget, January 9, 2020

product approval introduction

Bioness StimRouter Cleared in Europe to Treat Fecal Incontinence

Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence.  Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia. Read more.

Source: Medgadget, January 8, 2020

NorthShore Care Supply

NorthShore Announces Relocation

NorthShore Care Supply, the company behind NorthShore brand premium adult diapers, will be moving to a new 173,000 square foot facility in Green Oaks, IL, in March 2020. The new building more than doubles the current space and will include NorthShore’s headquarters, U.S. fulfillment center, contact center, research & development as well as quality control lab.  “It’s going to be an exciting year for our company as we complete our relocation and bring online our new fulfillment center with heavy investments in automation & robotics,” says Adam Greenberg, founder and president. “We also have planned investments in new products, advertising campaigns and an educational campaign designed to help end the blame, shame & stigma that exists around incontinence.” Read more.

Source: Nonwovens Industry, January 6, 2020

drugs for overactive bladder (OAB)

NDA Submitted for Vibegron for Overactive Bladder Treatment

Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.  The NDA submission includes data from an extensive clinical development program involving over 4000 patients with OAB. Results from the pivotal 12-week phase 3 EMPOWUR study support the efficacy and safety of vibegron in 1518 patients randomized to receive either vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily.  Read more.

Source: MPR, January 2, 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

product approval introduction

FDA Approves New Drug for UTI, Two Devices for OAB/Incontinence

November 2019 proved to be a fruitful month for urology-specific FDA approvals, with the agency giving the green light to a new drug for complicated urinary tract infection, an implantable device for the treatment of overactive bladder/retention, and a digital product for strengthening of pelvic floor muscles and treatment of urinary incontinence in women.  The FDA approved cefiderocol (FETROJA) in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following: susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Read more.

Source: Urology Times, December 4, 2019

product approval introduction

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.

Source: Business Wire, November 14 2019

Christopher K. Payne, MD

Christopher K. Payne, MD, FACS, to Receive Distinguished Philanthropist Award

Since 1989, the American College of Surgeons (ACS) has acknowledged individuals who have distinguished themselves through their exemplary investments in the mission of the College and in philanthropy with the Distinguished Philanthropist Award.  The Board of Directors of the ACS Foundation will present the 2019 Distinguished Philanthropist Award to Christopher K. Payne, MD, FACS, at its annual Donor Recognition Luncheon Monday. The award recognizes Dr. Payne for his philanthropic endeavors, service to the surgical profession, and long-lasting contributions to the medical community and the ACS. Read more.

Source: American College of Surgeons Clinical Congress News, October 31, 2019

NorthShore Care Supply

Catering to the Moderate to Heavy Incontinence Sufferer

While much of the new product development for adult incontinence today has led to thinner and thinner products for light incontinence, Illinois-based NorthShore Care Supply has focused on bringing innovation and dignity to those who suffer from moderate to heavy incontinence.  Witnessing family members struggling to manage their incontinence supplies using traditional retail products is what led Adam Greenberg to start up an adult incontinence business while completing his MBA at the University of Chicago Booth School of Business in 2002.  “At that that time, it was very confusing to shop for premium adult diapers online as everything sounded and looked the same and there was nobody that could help guide my family through this frustrating and embarrassing process,” says Greenberg, owner and president of NorthShore Care Supply. “So I studied up, and quickly became a diaper expert and was able to translate all the clinical specifications designed for nurses and hospitals into a very user friendly format that put families and patients at ease and made them feel like our products had a good chance to provide them the dignity and security that they’d been searching for.” Read more.

Source: Nonwovens Industry, October 17, 2019