Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from both […]
FDA wants tighter control of certain prostate ablation devices
The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
Corinth MedTech raises $12m for Veloxion urology device
Corinth MedTech said last week that it raised a $12 million Series D round for the urology device it’s developing. Cupertino, Calif.-based Micro Medical’s Veloxion device is designed to treat benign prostate hyperplasia and bladder tumors under continuous flow conditions using a bipolar resecting device, a fluid management system and integrated visualization technology. Proceeds from […]
Coloplast could sell its interventional urology business
Coloplast (CPH:COLO-B) recently confirmed that it is conducting an unconditional strategic review of its interventional urology division. That’s corporate speak for potentially selling it. The June 4 announcement came amid rumors of a potential sale. A Coloplast spokesperson had no further comments when reached by MassDevice. Coloplast’s interventional urology business grew 6% during the fiscal […]
Procept BioRobotics touts slew of Aquablation therapy study results
Procept BioRobotics today released results from a slew of studies of its Aquablation therapy provided with its Aquabeam robotic system, touting the device as durable, safe and effective. The AquaBeam system uses a robotically controlled waterjet to ablate prostate tissue without needing heat, the Redwood Shores, Calif.-based company said Results from the trials were presented […]
Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial
Axonics Modulation Technologies (NSDQ:AXNX) today released the results from the FDA investigational device exemption pivotal study of its r-SNM Sacral Neuromodulation system exploring its use in treating urinary dysfunction. The Irvine, Calif.-based company said it presented results from the study, dubbed the ARTISAN-SNM study, at the 2019 American Urological Association’s Annual Meeting in Chicago this week. Axonics […]
Teleflex touts real-world UroLift study data
Teleflex (NYSE:TFX) today released results from real-world studies of its UroLift minimally invasive treatment for benign prostatic hyperplasia, touting its safety and effectiveness. Data from the studies were presented at the 2019 European Association of Urology meeting in Barcelona, Spain. The UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the […]
Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal
Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement. The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]
NeoTract’s UroLift system gains expanded insurance coverage
Teleflex (NYSE:TFX) subsidiary NeoTract said that two more health insurers have agreed to offer coverage for the company’s UroLift system or patients with an enlarged prostate. The Wayne, Penn.-based subsidiary of Teleflex said that major U.S. insurer Humana and the Motion Picture Industry Pension & Health Plans (MPI), administered by Anthem Blue Cross, have added UroLift to its […]
Boston Scientific launches AdVance XP male stress urinary incontinence sling
Boston Scientific (NYSE:BSX) said late last week that it launched its AdVance XP male sling system intended to treat male stress urinary incontinence. The newly launched next-gen device includes a redesign intended to improve ease of placement and stability, and is available in longer sling lengths, the Marlborough, Mass.-based company said. “I believe the Advance XP Male […]
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