Endovascular Engineering (E2) has received a pair of FDA clearances for its pulmonary embolism treatment platform, spanning its dual-action thrombectomy system and hardware that returns filtered blood to the patient. The Hēlo system combines continuous vacuum aspiration with physical agitation to help break up the blood clot. Its catheter starts … [Read more...] about E2’s pulmonary embolism platform claims two FDA clearances
510(k)
Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
Total Flow Medical announced today that it received FDA 510(k) clearance for its TFA femoral arterial cannula device. Vancouver-based Total Flow Medical's TFA cannula received clearance for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours. Femoral arterial cannulation, a commonly used technique for … [Read more...] about Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
StarMed wins FDA clearance for RF ablation platform for thyroid nodules
StarMed announced today that it received FDA 510(k) clearance for its platform that delivers radiofrequency (RF) ablation of thyroid nodules. The company said this clearance makes it the first and only one with an FDA indication for RF ablation of thyroid nodules. Until now, according to StarMed, patients requiring thyroid nodule intervention … [Read more...] about StarMed wins FDA clearance for RF ablation platform for thyroid nodules
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
Sonorous Neurovascular earns FDA clearance for next-gen neurovascular catheter
Sonorous Neurovascular announced today that it received FDA 510(k) clearance for its BosCATH next-generation neurovascular catheter. Lake Forest, California-based Sonorous designed its BosCATH system to enhance access, delivery and procedural efficiency in complex cerebral venous and arterial anatomies. The company said its device provides … [Read more...] about Sonorous Neurovascular earns FDA clearance for next-gen neurovascular catheter
Rapid Medical earns FDA clearance for latest Tigertriever device
Rapid Medical announced today that it received FDA clearance for the Tigertriever 25 thrombectomy device, its latest addition to the platform. The company also reported the first clinical cases using the device in treating large vessel occlusion (LVO) stroke. Designed specifically for large clot burden in proximal vessels, Tigertriever 25 … [Read more...] about Rapid Medical earns FDA clearance for latest Tigertriever device
Protaryx earns FDA nod for transseptal puncture device
Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device. Baltimore-based Protaryx said clearance marks a significant advancement in its mission to redefine safe, efficient and reproducible left heart access. for cardiac interventions. It hopes to enable broader adoption and improved … [Read more...] about Protaryx earns FDA nod for transseptal puncture device
InVera wins FDA clearance for non-thermal infusion catheter
InVera Medical announced today that it received FDA 510(k) clearance for its InVera Infusion Device. Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a … [Read more...] about InVera wins FDA clearance for non-thermal infusion catheter
Haemonetics wins expanded FDA nod for vascular closure system in PFA, LAAC to treat AFib
Haemonetics (NYSE:HAE) announced today that it received FDA approval to expand the labeling for its Vascade MVP XL system. Expanded labeling includes procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. This grants Vascade MVP XL approval for larger sheaths used in market-leading technologies used for … [Read more...] about Haemonetics wins expanded FDA nod for vascular closure system in PFA, LAAC to treat AFib
Perfuze wins FDA clearance for standalone aspiration catheter
Perfuze announced today that it received FDA 510(k) clearance for its Millipede88 aspiration catheter. Galway, Ireland–based Perfuze designed the catheter for rapid and complete clot removal in patients suffering from large vessel occlusion (LVO) strokes. The company aims to improve stroke treatment outcomes and reduce procedural … [Read more...] about Perfuze wins FDA clearance for standalone aspiration catheter
