Medtronic today announced the full U.S. rollout of the Neuroguard IEP system, a carotid stent and embolic protection device. The launch follows a limited market release and builds on Medtronic’s exclusive U.S. distribution agreement with the device’s developer Contego Medical. Neuroguard IEP combines a nitinol stent, dilation balloon and … [Read more...] about Medtronic launches full U.S. distribution of Neuroguard IEP carotid stent system
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Outlook Surgical wins FDA clearance for hybrid endoscope system
Outlook Surgical this week announced it received FDA 510(k) clearance for its Inova 1 Towerless Endoscope System. The Bloomington, Illinois-based company designed the device to combine the features of a rigid and flexible scope into a single platform. It is intended for head and neck procedures, including ENT and related specialties. Outlook … [Read more...] about Outlook Surgical wins FDA clearance for hybrid endoscope system
AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
AngioSafe announced it has received FDA 510(k) clearance and CE marking for its Santreva-ATK endovascular revascularization catheter. San Jose, California–based AngioSafe designed the device for wire-free intraluminal crossing of chronic total occlusions (CTOs) while simultaneously compressing plaque and recanalizing vessels. Santreva-ATK enables … [Read more...] about AngioSafe emerges from stealth with FDA clearance for Santreva-ATK catheter
SMT reports positive 3-year results from Supraflex Cruz stent trial
Sahajanand Medical Technologies (SMT) announced that the FIRE trial showed sustained safety and efficacy of its Supraflex Cruz drug-eluting stent in elderly patients with myocardial infarction and multivessel disease. Results were presented at the European Society of Cardiology (ESC) Congress 2025. The randomized study enrolled 1,445 patients … [Read more...] about SMT reports positive 3-year results from Supraflex Cruz stent trial
Terumo Neuro recalls some Fred 27 neurovascular stents over tantalum wire issue
Terumo Neuro's MicroVention issued an urgent medical device recall of some Fred 27 and Fred X 27 Flow re-direction endoluminal devices. The company is voluntarily recalling certain lots of the devices due to complaints of a manufacturing error related to the tantalum length and attachment pattern. Terumo Neuro stated that the complaints have also … [Read more...] about Terumo Neuro recalls some Fred 27 neurovascular stents over tantalum wire issue
Dornier MedTech launches new ureteral access sheath and ureteroscope in U.S.
Dornier MedTech America announced the full U.S. commercial launch of two single-use devices, the Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath and the Dornier Axis II Slim ureteroscope. Both devices had already received FDA clearance and were in limited release before the full U.S. launch. The Hoover sheath provides … [Read more...] about Dornier MedTech launches new ureteral access sheath and ureteroscope in U.S.
MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe. The approval makes Alwide Plus the company’s fourth product authorized in Europe, following the VitaFlow Liberty transcatheter aortic valve and delivery system, and the AnchorMan left atrial appendage … [Read more...] about MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
STENTiT enrolls first patient in trial of regenerative stent system
STENTiT has implanted its Resorbable Fibrillated Scaffold in the first patient enrolled in the VITAL-IT 1 study evaluating the device for chronic limb-threatening ischemia (CLTI) below the knee. The prospective, non-randomized feasibility study will enroll up to 10 patients at the Medical University of Graz in Austria and follow them for 24 … [Read more...] about STENTiT enrolls first patient in trial of regenerative stent system
Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
Ancora Heart announced it has reached the first enrollment milestone in its CORCINCH-HF pivotal trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System for patients with heart failure with reduced ejection fraction (HFrEF). The trial has now enrolled 250 randomized patients. Data collected at six months will support the … [Read more...] about Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
InspireMD wins CE Mark approval for CGuard Prime
InspireMD today announced it received CE Mark approval for its CGuard Prime carotid stent system for the prevention of stroke. The Miami-based company said the next-generation carotid stent system was developed based on physician feedback and features improved deliverability and deployment. It builds on the original CGuard design, which uses a … [Read more...] about InspireMD wins CE Mark approval for CGuard Prime
