EmStop announced today that it kicked off the CAPTURE-2 FDA investigational device exemption (IDE) study of its embolic protection system (EPS). CAPTURE-2 evaluates the safety and performance of the EPS, an investigational device for cerebral embolic protection designed to capture and remove debris that includes thrombus during commercially … [Read more...] about EmStop initiates IDE study of novel embolic protection device
Technologies & Devices
Artivion closes $175M acquisition of aortic arch maker Endospan
Endospan announced today that Artivion completed its $175 million acquisition of the company, following FDA approval for its Nexus system. The FDA granted premarket approval (PMA) for the Nexus aortic arch system last month. Nexus treats aortic arch disease, including chronic aortic dissections, in patients at high risk for open surgical repair. … [Read more...] about Artivion closes $175M acquisition of aortic arch maker Endospan
Boston Scientific treats first patient with Seismiq IVL in ELEGANCE registry
Boston Scientific (NYSE:BSX) today announced the first patient treated with its Seismiq IVL system in the ELEGANCE registry. Dr. Michael R. Jaff, chief medical officer and VP of Peripheral Interventions at Boston Scientific, shared the news of the first IVL (intravascular lithotripsy) patient treated in the registry on LinkedIn. The ELEGANCE … [Read more...] about Boston Scientific treats first patient with Seismiq IVL in ELEGANCE registry
Corvention earns FDA clearance for aortic valve balloon catheter
Corvention announced today that it received FDA 510(k) clearance for its KardiaPSI balloon catheter device. Flagstaff, Arizona-based Corvention's device is indicated for balloon aortic valvuloplasty (BAV). The company says it provides interventionalists with an ultra-high-pressure solution for the precise dilation of stenotic aortic … [Read more...] about Corvention earns FDA clearance for aortic valve balloon catheter
Aurie wins FDA nod for reusable intermittent catheter system
Aurie announced today that it received FDA de novo clearance for its Aurie Reusable No-Touch Intermittent Catheter System. The Syracuse, New York–based company says the milestone makes its system the first ever reusable intermittent urinary catheter system to gain clearance through this pathway. It plans to begin commercial efforts with a launch … [Read more...] about Aurie wins FDA nod for reusable intermittent catheter system
Stryker completes acquisition of Amplitude Vascular Systems
Stryker (NYSE:SYK) announced today that it completed its acquisition of Amplitude Vascular Systems (AVS) for an undisclosed amount. AVS develops an intravascular lithotripsy (IVL) platform designed to treat calcified peripheral arterial disease (PAD). It uses pulsed CO₂-generated pressure waves delivered uniformly through an IVL balloon … [Read more...] about Stryker completes acquisition of Amplitude Vascular Systems
Aqua Medical shares data backing ablation procedure for treating diabetes
Aqua Medical today announced the presentation of 12-month follow-up data for its proprietary radiofrequency vapor ablation (RFVA) platform. Pleasanton, California-based Aqua Medical designed its Proximal Intestinal Mucosal Ablation (PIMA) procedure to use its proprietary RFVA system. PIMA, a minimally invasive outpatient endoscopic procedure, … [Read more...] about Aqua Medical shares data backing ablation procedure for treating diabetes
Neptune announces positive results from first-in-human robotic endoscopy study
Neptune Medical today announced positive findings from its 50-patient, first-in-human CARE 1 study of its Triton robotic endoscopy system. Triton, a gastrointestinal (GI) robotic endoscopy system, aims to provide easy and comfortable navigation, precision and control throughout the colon. It combines robotic precision and AI-assisted detection … [Read more...] about Neptune announces positive results from first-in-human robotic endoscopy study
Sensome reports positive findings for clot-sensing guidewire
Sensome today announced the publication of first-in-human results from the CLOT OUT study evaluating its Clotild smart guidewire system. Findings published in the Journal of Neurointerventional Surgery demonstrated, for the first time, the ability of Clotild to accurately characterize clot from inside a fully occluded brain vessel. The study … [Read more...] about Sensome reports positive findings for clot-sensing guidewire
InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
InspireMD (Nasdaq:NSPR) announced today that, in consultation with the FDA, it recalled its CGuard Prime 135 cm carotid stent delivery system. The company said it initiated a voluntary recall for the system. After a controlled launch, the company determined that the technical success of the delivery system during carotid artery stenting … [Read more...] about InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
