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clinical medical

Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study.  Read more.

Source: Business Wire, September 10, 2020

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An Emerging Link Between the Urinary Microbiome and Urinary Incontinence

Most people know that microorganisms live on our skin, and in other places in the body such as the digestive tract. However, traditional thinking and medical teaching was that there was no such microbiome in the urinary tract. Many people may still believe that urine is sterile. Advanced detection methods such as enhanced urine cultures and DNA sequencing have shown that this is not true. Read more.

Source: Harvard Health Blog, August 12, 2020

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FDA Approves New Devices for Bladder and Bowel Control Conditions

The FDA has approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions, according to Medtronic plc, the manufacturer of the devices.  InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation (SNM) therapy. SNM sends “electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Read more.

Source: Urology Times, August 6, 2020

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

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Rigicon Launches Two New Artificial Urinary Sphincter Systems for Incontinence Treatment

Rigicon announces that ContiClassic® Artificial Urinary Sphincter and the ContiReflex® Artificial Urinary Sphincter models have recently received CE Mark Approval and is initially available in all major European markets.  ContiClassic® Artificial Urinary Sphincter and ContiReflex® Artificial Urinary Sphincter are implant devices that treat Urinary Incontinence (UI). Conti® Artificial Urinary Sphincter Systems are indicated to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery. Conti® Artificial Urinary Sphincter Systems are designed to restore the function of the normal (healthy) urinary sphincter that restricts urine flow out of the bladder. Read more.

Source: PRWeb, May 7, 2020

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ProvenMed Launches Online Store for Easy and Private Access to Its Innovative Incontinence Devices

UAE-based medical devices company ProvenMed Global FZ-LLC announced today that its online store, shop.provenmed.com, is now open for business. The company is also offering a limited time-only discount up to 40% on all products purchased via the online store.  ProvenMed specializes in urinary continence innovation and is renowned for their flagship suite of products called ActivGo®. It was the world’s first reusable and washing system-integrated urinary external catheter for male incontinence management. Read more.

Source: ProvenMed, April 12,2020