Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Safe Medical Design, a company based in San Francisco, CA, won FDA clearance for its Signal Catheter device. The indwelling foley urinary catheter is designed to help prevent discomfort and injury that can occur if it’s incorrectly placed, an all-too-common occurrence. Indwelling urinary catheters typically have a balloon at the tip that is inflated once it’s within the bladder. This prevents the catheter from sliding out. When the patient is “dry” and no urine is in the catheter, it’s often difficult to tell whether the catheter tip made it into the bladder, at times resulting in premature inflation that can cause serious trauma. The Signal Catheter is made of 100% silicone and it features a mechanism that relieves the pressure inside the balloon if it is improperly positioned and inflated inside the urethra. Read more.
Source: Medgadget, March 1, 2019
Tepha has announced the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI). The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa(“PFFSA”) and the University of Cape Town. The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands. The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology. Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure. Read more.
Source: Compelo, February 28, 2019
Hollister Incorporated, a US-based company that develops, manufactures, and markets healthcare products and services worldwide, has launched the Infyna Chic intermittent catheter, the latest in the company’s line of female hydrophilic catheter products. Designed to help provide women who use catheters with a high level of discretion, the new catheter received CE approval in December 2018. The Infyna Chic catheter will be joining the Infyna Standard and Plus catheters to complete the Infyna portfolio, offering women a range of options to meet their individual needs. In the coming months, the product will be available in Europe and Canada. Read more.
Source: PRNewswire, February 27, 2019
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System1. The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. Read more.
Source: Business Wire, February 26, 2019
Axonics, based in Irvine, California, won European regulatory approval for MRI conditional labeling for its sacral neuromodulation (SNM) system for treatment of overactive bladder, urinary retention, and fecal incontinence. The Axonics SNM system is now compatible, given certain precautions, with 1.5 Tesla and 3 Tesla MRI scanners. It is the only SNM system cleared in Europe with such labeling. The implant is rechargeable, and so can be used for much longer periods than similar devices that have to be replaced with fresh batteries. The company promises a lifetime of up to 15 years, Axionics claims is three times longer than Medtronic’s InterStim. Additionally, it’s 60% smaller. Read more.
Source: Medgadget, February 26, 2019
Scanning the bladder and measuring its volume is a common procedure usually performed by nurses. It may be done for a variety of reasons, but achieving accuracy is key. Catheterization-based methods may be the most accurate, but non-invasive ultrasound is a lot more attractive. With conventional ultrasound one must be very careful to properly gauge the margins of the bladder, then essentially use a ruler on a 3D object, and finish using a formula that really only provides a rough estimate. EchoNous, based in Redmond, Washington, has released a device that lets nurses measure bladder volume faster and with greater confidence, hopefully resulting in more accurate numbers. Read more.
Source: Medgadget, February 20, 2019
The Food and Drug Administration (FDA) has granted Fast Track designation to RDD-0315, a novel topical gel for the treatment of fecal incontinence in spinal cord injury patients. RDD-0315 contains the alpha-agonist oxymetazoline in a topical gel formulation; it works by contracting the internal anal sphincter muscle. In a randomized, controlled crossover study involving 19 patients with spinal cord injury, the investigational gel was found to be beneficial, due to the local effect of oxymetazoline; a statistically significant reduction in the number of fecal incontinence episodes was observed 8 hours and 12 hours post-administration. Read more.
Source: MPR, February 15, 2019