Investigational Device Exemption (IDE)
California-based Reverse Medical landed key FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for treatment of intracranial bifurcation aneurysms.
The company plans to finalize its trial structure "very soon" and begin enrolling patients within the next few months, president & CEO Jeffrey Valko said in prepared remarks.
California biotech company Valor Medical, 4 executives and a consultant admitted to the Dept. of Justice that they concealed information about their Neucrylate diagnostic assay, hiding toxicity reports that were required as the product was undergoing FDA premarket review.
Claret Medical is clear to launch a pivotal U.S. trial of its Sentinel cerebral protection system, having won FDA approval to evaluate the device in patients undergoing transcatheter aortic valve implantation.
The study is slated to begin in the 1st quarter of 2014 and will involve up to 15 clinical centers, Claret reported.
By Stewart Eisenhart, Emergo Group
W.L. Gore & Associates enrolled the 1st patient in its U.S. Gore TAG thoracic branch endoprosthesis LSA feasibility study in hopes of landing FDA approval for treatment of thoracic aortic aneurysms in the left subclavian artery.
Claret Medical said it filed asked for an investigative device exemption from the FDA for a clinical trial of its Sentinel cerebral protection system.
Santa Rosa, Calif.-based Claret wants to conduct a multicenter study using the Sentinel for embolic protection during transcatheter aortic valve implantation, comparing use of the Sentinel device with standard care.
USGI Medical will enroll up to 350 patients in an FDA-approved clinical trial of the g-Cath EZ suture anchor delivery catheter, an incision-free bariatric surgery technology that has already been used on more than 2,000 patients, mostly in Europe.