Product Update: HIFU cleared, compact catheter launched


Other products highlighted in this slideshow include a trial system for incontinence therapy, a compact catheter, a wearable digital technology solution for continence care assessment and management, and laser fiber and sheath system.




SonaCare Medical receives FDA clearance for HIFU prostate device

Charlotte, NC-SonaCare Medical, LLC received FDA clearance to market the Sonablate 450 in the U.S. for the ablation of prostate tissue. Sonablate uses high-intensity ultrasound (HIFU) to deliver precise and focused ablation, according to SonaCare Medical. It’s powered by A3 Technology, which allows physicians to aim energy at specific tissue using integrated ultrasound imaging and sophisticated planning tools; ablate targeted tissue with HIFU ablation that provides pinpoint accuracy while sparing untargeted tissue; and analyze procedure results using real-time ultrasound imaging along with advanced tissue change monitoring software. SonaCare Medical was expected to begin U.S. distribution in October.  

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FDA approves expanded use of trial system for incontinence therapy

Dublin, Ireland-The FDA has approved the use of the Verify Evaluation System for basic evaluations, which last 3-7 days, thereby expediting the potential for long-term restoration of bladder or bowel function. The Verify System allows patients to test the benefits of Medtronic Bladder or Bowel Control Therapy (sacral neuromodulation), delivered by the InterStim System for the chronic symptoms of overactive bladder, nonobstructive urinary retention, or bowel incontinence in patients who did not have success with more conservative therapies. The Verify System includes a wireless touch-screen controller and a small, concealable external neurostimulator device. It allows patients to perform many normal daily activities while undergoing the evaluation. A trial can be considered a success if a patient experiences a significant reduction in bladder control symptoms.

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Small-size catheter for men is compact, portable, discreet

Minneapolis-Coloplast announced the U.S. launch of SpeediCath Compact Male, a compact catheter for men. The new product is less than half the size of a standard male catheter and may be stored, carried, used, and disposed of discreetly. The SpeediCath Compact Male all-in-one design is instantly ready to use, featuring “no touch” insertion and withdrawal that provides a level of convenience and is usable in any location at any time, according to Coloplast.

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Wearable technology offers solution for continence care, management

Sydney, Australia and Atlanta-The Smart Incontinence Management (SIM) medical device is the world’s first wearable integrated digital technology solution for continence care assessment and management, according to Simavita. It detects multiple incontinence episodes through a sensor embedded into an adult incontinence pad. The SIM sensor is a single-use disposable device that connects to a durable transceiver that records and wirelessly transmits incontinence data to a server for storage and processing. Collected data are synchronized with incontinence-related observations recorded by staff via an application displayed on a tablet or phone and can be used by the clinician to develop an evidence-based toileting plan.

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System helps safeguard scopes’ working channel from damage

El Segundo, CA-KARL STORZ Endoscopy-America, Inc. announced the availability of the FLEX-GUARD Laser Fiber and Sheath System, which helps to safeguard ureteroscopes’ working channel from both mechanical and thermal damage. The system is used with the company’s FLEX-XC or FLEX-X2 flexible ureteroscopes. The FLEX-GUARD comes preassembled with a ScopeSafe laser fiber and protective sheath. The easy-to-use sheath with Micro Adjuster have clear markers to indicate when the sheath is covering the fiber tip and is ready for insertion, according to KARL STORZ. This design facilitates multiple passes of the fiber through a deflected scope, simplifying the procedure. The FLEX-GUARD is available in three sizes, and non-sheathed ScopeSafe laser fibers are also available.

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