product approval

Axonics® Receives IDE Clearance from US FDA to Conduct Pivotal Study

Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.  “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.

Source: Pharmaweb, November 7, 2017

Florence Italy ICS 2017

Positive Results for the Axonics® RELAX-OAB Clinical Presented at ICS

Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter clinical study at the 2017 International Continence Society (ICS) Congress in Florence, Italy.  The presentation, entitled “A prospective multicenter clinical study evaluating a miniaturized rechargeable sacral neuromodulation system for the safe and effective treatment of overactive bladder (RELAX-OAB study),” was delivered by Bertil F.M. Blok, M.D., PhD, Dept. of Urology, Erasmus University Medical Centre, Rotterdam, Netherlands.  Read more.

Source: Business Wire, September 13, 2017

sacral nerve stimulation

Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB

Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome.  InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.

Source: MassDevice Today, July 17, 2017

business buildings

Unique Method Trains Brain of Incontinence Patients

Czech experts have developed a unique method to help patients with urinary incontinence by teaching their brain to ignore false signals it receives from their hyperactive bladder, daily Hospodarske noviny (HN) wrote on Wednesday.  The breakthrough method, together with a special device it uses, will facilitate the treatment of incontinence, the experts from Charles University’s 2nd Medical Faculty say.  The device will be produced by the Tesla Medical company, which has gained 20 million crowns from small investors for this purpose, HN writes.  Read more.

Source: Prague Daily Monitor, July 12, 2017.

business buildings

Astellas Submits Supplemental New Drug Application for Mirabegron

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency.  Read more.

Source: PRNewswire, June 29, 2017

hurrying with overactive bladder

Identifying Overactive Bladder Syndrome

An interview with Dr Michael Kennelly, urologist and Medical Director for the Charlotte Continence Center at Carolinas Medical Center, conducted by April Cashin-Garbutt, MA (Cantab)  What are the main symptoms of overactive bladder syndrome (OAB)?  Symptoms of OAB include leakage, the strong sudden need to “go right away,” and going to the bathroom too often. Read more.

Source: News-Medical.Net, June 28, 2017

elderly underactive bladder symptoms needed to be reported

Drug Tied to Dementia Risk Overprescribed to Seniors: Study

A drug linked to a raised risk of dementia is taken by millions of older Americans who have an overactive bladder, researchers say.  More than one-quarter of patients with the urinary problem had been prescribed the drug oxybutynin (Ditropan), an international team of investigators found.  Yet, “oxybutynin is a particularly poor drug for overactive bladder in elderly patients,” said study lead author Dr. Daniel Pucheril, a urologist at Henry Ford Hospital in Detroit.  Prior studies have linked the drug to thinking problems and increased risk of dementia in older people, possibly because of the way it affects brain chemicals, he said.  “It’s a great and effective drug for younger patients, but is a risky drug for older patients,” Pucheril said. It boosts dementia risk even when not taken indefinitely, he said.  Alternatives exist but they’re more expensive and may not be covered by insurance, at least initially, the study authors explained.  Read more.

Source: HealthDay News, March 30, 2017

Health Canada logo

Axonics Sacral Neuromodulation System Receives Marketing Approval

Axonics Modulation Technologies, Inc. announced today that it received a Homologation d’un instrument médical (medical device approval) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.  The Health Canada license confirms that the Axonics® product meets all of the Canadian Medical Devices Regulations, Section 36, for Active Implantable Medical Devices and enables Axonics to market its r-SNM System throughout Canada. Read more.

Source: Yahoo! Finance, January 5, 2017

operating room

StimGuard Enrolls First Patient in Office-Based Chronic Tibial Nerve OAB Incontinence Stimulation Study Utilizing the World’s Smallest Wireless System

StimGuard, a privately-held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first miniature implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through an introducer device the size of a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter. Read more.

Source: Business Wire, December 15, 2016

hormones change as women age

When Bathroom Runs Rule the Day (and Night)

I have only one regret about not having been born a male, and it concerns plumbing, namely how easy it is for men to eliminate liquid waste,  whether by avoiding long bathroom lines or being able to relieve themselves discreetly when no facility is available.  My male envy grew after I contracted poison ivy on unmentionable parts when nature called during a hike in the woods. Urination has long been a vexing problem for women.  Read more.

Source: New York Times, December 12, 2016