Also read about expansions to an intermittent catheter line, a new radiofrequency treatment for improving local vaginal circulation, an app for men navigating fertility challenges, and more.
Laser line offers dusting, fragmentation, ablation capabilities
Olympus has launched its EMPOWER laser portfolio line, which offers a range of capabilities in Ho:YAG lithotripsy, including dusting, fragmentation, and soft tissue ablation. The EMPOWER system offers physicians and hospitals several choices in mode, power, and frequency. Its Stabilization mode reduces retropulsion effect, meaning that it produces a vapor tunnel bubble path to the stone to stabilize the stone and limit retropulsion. Olympus says the high-power platform offers greater efficiency and higher hertz than competitive systems with similar power offerings and also features customizable user settings.
Intermittent catheter line expands with affordable additions
CompactCath has expanded its intermittent urinary catheter product line with the addition of CompactCath CoudÃ© and OneCath. Available in both a straight and coudÃ© tip in pediatric and adult sizes, OneCath is a high-quality catheter at an affordable price point, CompactCath says. CompactCath CoudÃ© (shown) combines the compact design of CompactCath, providing a smaller, easy-to-use, and discreet catheterization experience. The company says it is the only pocket-sized 16-inch long catheter with a coudÃ© tip that fits in the palm of the hand and features a 100% non-touch system, fire-polished eyelets, silicone oil lubrication, and drainage control. The new FDA- and CE-approved catheters are 100% DEHP, BPA, and rubber latex-free.
RF treatment improves local vaginal circulation
TempSure Vitalia from Hologic's Cynosure division is a new FDA-cleared advanced radiofrequency treatment that delivers therapeutic heat to internal and external vaginal tissue to improve local circulation. The treatment, administered using a probe specifically designed for women's genitalia, delivers precise heating for smaller, hard-to-reach areas such as vaginal and labial tissue, without hormones or the need for invasive procedures. TempSure Vitalia features Therapeutic Logic Control, a time and temperature monitoring system that ensures treatment timing will begin only when the target tissue is at therapeutic temperature.
App helps men navigate fertility challenges
Ferring Pharmaceuticals has teamed up with fertility experts to launch FertiSTRONG, a fertility mobile application designed specifically for men. The app is designed to better help men navigate fertility challenges and address the current lack of available resources. FertiSTRONG provides more than 500 custom coping options for over 50 specific situations that have the potential to cause distress for men throughout the family-building journey and serves as a helpful resource for the exact moment that a man may feel stressed, whenever and wherever they are, by providing them with techniques and strategies for common scenarios they may face, according to Ferring.
FDA approves new abiraterone formulation
Sun Pharma and Churchill Pharmaceuticals, LLC announced the approval of abiraterone acetate (YONSA), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer. YONSA uses proprietary SoluMatrix Fine Particle Technology to create a micronized formulation of abiraterone tablets. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17Î±-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis.
HIFU device fuses magnetic resonance and 3-D biopsy data with real-time ultrasound imaging
EDAP TMS SA received FDA 510(k) clearance for its Focal One high-intensity focused ultrasound (HIFU) device for the ablation of prostate tissue. Focal One fuses magnetic resonance and 3-D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3-D images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area. Focal One is the first medical device designed specifically for focal treatment of the prostate, according to EDAP TMS.
Sublingual tablet treats nocturia due to nocturnal polyuria
Ferring Pharmaceuticals Inc. announced approval to market desmopressin acetate (NOCDURNA), the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The formulation of the sublingual tablet and sex-specific dosing was demonstrated to be effective in reducing nighttime trips to the bathroom in adults 18 years and older. Clinical trials demonstrated an average reduction of nighttime voids of 52% in women and 43% in men relative to mean baseline (reduction of 1.5 and 1.3 voids, respectively).
Next generation in microcatheter for BPH now available in three lengths
Embolx, Inc. received FDA 510(k) clearance for its next generation family of Sniper Balloon Occlusion Microcatheters, a system for pressure-directed arterial embolization therapy. The Sniper microcatheter alters blood flow dynamics by controlling pressure to increase therapeutic agent delivery into target areas. It is currently used for the treatment of BPH, cancerous tumors in the liver and other organs, and uterine fibroids. It is now available in three lengths-110 cm, 130 cm, and 150 cm-enabling physicians to access either femoral or radial arterial sites.
‘Smart’ lithotripter uses real-world ESWL data
Dornier MedTech has introduced Dornier Delta III SmartLitho, which the company says is the first lithotripter system that uses big data in urology. Delta® III SmartLitho™ can utilize Dornier’s proprietary analytic algorithm, which is able to provide real-world data from extracorporeal shockwave lithotripsy (ESWL) treatments of urologic stones by validating against a broad set of data points collected globally. The novel algorithm enables urologists to make personalized, evidence-based decisions by assessing historical success rates of treatment modalities as well as identify and balance costs.
Test guides treatment for cystitis, complicated UTI, prostatitis
GenomeDx Biosciences and Pathnostics have launched the next generation Guidance diagnostic testing for patients suffering from simple cystitis; recurrent, persistent, or complicated urinary tract infections; prostatitis; and interstitial cystitis. The Guidance test is performed by Pathnostics and distributed by GenomeDx to urologists. The molecular test helps personalize treatment options through swift identification of 42 pathogens followed by antibiotic sensitivity for the collection of identified pathogens, and this next generation of Guidance adds the evaluation of the presence of antibiotic-resistant genes, according to the companies.
Ultrasound maker, GPO partner on prostate biopsy solution
Exact Imaging, a leader in high resolution micro-ultrasound systems enabling real-time imaging and prostate biopsy guidance, has become a UroGPO Imaging Partner. UroGPO is a urology-specific group purchasing and service organization. As an Imaging Partner, Exact Imaging’s ExactVu micro-ultrasound platform for targeted prostate biopsies will be available to UroGPO’s 550-plus member urology practices as part of the UroGPO suite of offerings to U.S. urology practices. Exact Imaging will provide UroGPO members with preferential pricing for the ExactVu platform, as well as a collection of value-added services including enhanced instructor-led training, extended support, and a patient-focused marketing toolkit.
Intravenous agent treats complicated UTI
Achaogen, Inc. announced FDA approval of plazomicin (ZEMDRI), for adults with complicated urinary tract infections, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Plazomicin, an aminoglycoside, is an intravenous infusion administered once daily. It is designed to retain its potent activity in the face of certain difficult-to-treat multidrug-resistant infections, including carbapenem-resistant (CRE) and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.