NeuroPace said today that its epilepsy neuromodulation technology will be studied for its efficacy in treating binge-eating disorder in certain patients. The Mountain View, Calif.-based company’s RNS system is a closed-loop technology approved to treat adults with medically refractory focal onset epilepsy. The clinical trial will examine whether neuromodulation could help patients with a body […]
Clinical Trials
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery. With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. […]
Study: Boston Sci’s Watchman cheaper than drugs long-term
Updated to include comments from the principal investigator. A new study has found that use of the Boston Scientific (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device to treat atrial fibrillation costs less than existing and novel anticoagulant drugs over five years. Researchers conducted the analysis using an Excel-based simulation model developed to assess the […]
Taris Biomedical touts results of bladder cancer treatment study
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 The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls.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 […]
Transplant Biomedicals touts kidney transport device study results
Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
FDA OKs trial for Micro Medical’s below-the-knee stent
Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease. The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints […]
Obalon readies $17m offering for retail pivot
Obalon Therapeutics (NSDQ:OBLN) last week registered a stock offering worth more than $17 million that it plans to use to finance its pivot to retail. In April the Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, revealed plans to lay off 50% of its employees, including all of its direct sales force, in a […]
Ra Medical launches large registry trial for peripheral laser device
Ra Medical (NYSE:RMED) said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue. The 2,500-patient Results […]
Axonics wins FDA nod for MR-safe neurostim device in trial
Axonics Modulation Technologies (NSDQ:AXNX) said today that the FDA approved the use of full-body MRI for clinical trial participants implanted with the company’s sacral neuromodulation device. The Irvine, Calif.-based company submitted a supplement to the FDA regarding the use of full-body MRIs in its Artisan-SNM 129-patient pivotal trial. The FDA, which is evaluating Axonics’ device via […]