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

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

business buildings

Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

Medtronic plc (MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval. Read more.

Source: Globe Newswire, October 7, 2019

doctor and patient

AUA Updates Overactive Bladder Guideline

The American Urological Association (AUA) announced that it has updated its guideline for the diagnosis and treatment of non-neurogenic overactive bladder (OAB) in adult patients.  As a result of a 2018 systematic review of recently published studies, AUA modified guideline statement 12 to say clinicians may consider combination therapy with an antimuscarinic agent and beta3-andrenoceptor agonist for patients who are refractory to monotherapy with either of those medications. Read more.

Source: Renal & Urology News, April 25, 2019

drugs for overactive bladder (OAB)

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow.  It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective.   Read more.

Source: Evaluate, March 12, 2019

doctor male discussion

Overactive Bladder Linked to Prostate Cancer ADT

Androgen deprivation therapy (ADT) for prostate cancer is associated with an increased risk of overactive bladder (OAB), a finding consistent with an inhibitory role of androgen in modulating male voiding dysfunction, according to a new study.  Compared with ADT recipients, healthy men and men receiving alpha blockers for benign prostatic hyperplasia (BPH) had a significant 98% and 30% decreased risk of OAB, respectively, after adjusting for numerous potential confounding factors. Increased ADT duration increased the cumulative risk of OAB. Read more.

Source: Renal & Urology News, January 7, 2019

medical research

Tiny, Implantable Device Uses Light to Treat Bladder Problems

A team of neuroscientists and engineers has developed a tiny, implantable device that has potential to help people with bladder problems bypass the need for medication or electronic stimulators.  The team—from Washington University School of Medicine in St. Louis, the University of Illinois at Urbana-Champaign, and the Feinberg School of Medicine at Northwestern University in Chicago—created a soft, implantable device that can detect overactivity in the bladder and then use light from tiny, biointegrated LEDs to tamp down the urge to urinate. The device works in laboratory rats and one day may help people who suffer incontinence or frequently feel the need to urinate. The new strategy is outlined in an article published Jan. 2 in the journal Nature. Read more.

Source: Medical Xpress, January 2, 2019

patient education OAB

Free Interactive Education Program Announced for Those Living With an Overactive Bladder

According to the American Urological Association, approximately 40% of women and 30% of men live with overactive bladder or OAB. Many people with OAB find it difficult to talk to their doctor or loved ones about their condition because of the stigma associated with it. Pro-ficiency, a leading provider of interactive online patient education tools, announces its collaboration with the Academy for Continued Healthcare Learning (ACHL) and the Simon Foundation for Continence, in their joint, interactive program, to educate people about how to speak with their healthcare providers and their loved ones to get the care they need. The program also discusses treatment options, how to manage social and lifestyle considerations, and incorporating shared-decision making into visits with health care providers. The program is freely available to all participants.  “ACHL & Pro-ficiency previously collaborated on a highly successful OAB educational activity, however, given the depth and breadth of OAB, it was clear that continued education was needed. ACHL is proud to continue the education movement with this most recent program,” adds Amanda Kaczerski, with ACHL. Read more.

Source: Newswire, November 5, 2018

business buildings

The Journal of Urology Publishes Valencia’s Excellent Feasibility Data on eCoin™ for Overactive Bladder

Last week, The Journal of Urology published the feasibility data of Valencia Technologies’ (“Valencia“) eCoin™ device indicated for treatment of overactive bladder.  The manuscript, “Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence,” details the design of Valencia’s 46 patient study and the study’s excellent clinical results.  The manuscript has an embargo date of February 15, 2019. Implanted in a 20-minute office procedure across seven clinical centers in the United States and New Zealand, the coin-sized and shaped tibial nerve stimulator is distinctly simple to implant in stark contrast to a highly invasive and operator dependent therapy called sacral nerve stimulation. An author of the eCoin™ publication, Dr. Vincent Lucente, concludes, “I believe tibial nerve stimulation with eCoin™ will become the therapy of choice for patients after medications are tried. These early results clearly show a better therapy is on the horizon for patients with urinary incontinence.” Read more.

Source: PRNewswire, November 1, 2018