Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later […]
Clinical Trials
J&J’s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system. The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation […]
WaveForm touts clinical trial data for continuous glucose monitor
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The WaveForm CGM system is designed to be worn for 14 days and includes a sensor insertion tool, a small sensor wire, a polymer coating […]
Abbott, Nevro tout spinal cord stimulation tech
Abbott (NYSE:ABT) and Nevro (NYSE:NVRO) touted their spinal cord stimulation technologies at the annual North American Neurological Society meeting in Las Vegas. Two-year data from Abbott’s 42-patient Sunburst study revealed that a majority of patients chose its BurstDR therapy when given the choice during the long-term follow-up period and that stimulation from BurstDR provided pain relief […]
Boston Scientific touts spinal cord stim pain-relief trial
Boston Scientific (NYSE:BSX) touted data today from a trial evaluating spinal cord stimulation therapy in patients seeking pain relief. The Whisper trial showed that patients who are given the choice to use both sub-perception and paresthesia-based spinal cord stimulation therapy experience better outcomes compared to patients who have just one spinal cord stimulation therapy option. In […]
LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual […]
Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. Get the full story at our sister site, Drug […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s (NYSE:MDT) Resolute […]
Eyenovia sets range for IPO
N.Y.-based startup Eyenovia updated its regulatory filings to reveal that it plans to offer 2.73 million shares priced between $10 – $12 apiece in its initial public offering. The 7-person company, which is developing a device to deliver small doses of drugs to the eye, is applying to list on the Nasdaq exchange under the symbol, “EYEN”. Get the […]
BioProtect wins FDA IDE nod for ProSpace trial
Oncology device developer BioProtect said today it won FDA investigational device exemption approval to launch a pivotal clinical study of its ProSpace balloon system designed to prevent rectal toxicity following prostate cancer radiotherapy. The ProSpace balloon system is a novel balloon spacer designed to temporarily separate the rectum from the prostate during prostate cancer radiation therapy to […]
GenSight to launch trial of gene therapy, visual stimulation device combo in UK
The UK’s Medicines and Healthcare Regulatory Agency has approved GenSight Biologics‘ (EPA:SIGHT) application to combine gene therapy and a wearable optronic visual stimulation device in patients with retinitis pigmentosa. The first-in-man Phase I/II trial is designed to study the safety and tolerability of GenSight’s GS030 combination therapy in three groups of three patients each. Get the […]