Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
Pre-Market Approval (PMA)
FDA approves Merit Medical’s cell-impermeable endoprosthesis
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It … [Read more...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and … [Read more...] about Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies … [Read more...] about Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
Philips launches Duo venous stent system with FDA approval
Philips today announced the first implant of its Duo venous stent system following FDA premarket approval. Duo, an implantable medical device, treats symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI). Amsterdam-based Philips added Duo to its portfolio when it acquired Vesper Medical in 2021. On June … [Read more...] about Philips launches Duo venous stent system with FDA approval
