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
Regulatory
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
BD picks up CE mark for next-gen stent graft
BD (NYSE:BDX) announced today that it received CE mark approval for its Liverty TIPS stent graft system. Franklin Lakes, New Jersey-based BD designed the stent graft to expand treatment options for patients with cirrhosis and complications of portal hypertension. The next-generation, adjustable-diameter device marks the latest advancement for … [Read more...] about BD picks up CE mark for next-gen stent graft
Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial. FULCRUM-VT evaluates the company's vCLAS cryoablation technology for treating cardiovascular disease. Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low … [Read more...] about Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter
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
Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
Johnson & Johnson (NYSE:JNJ) announced today that it launched the Varipulse Pro system in Europe following CE mark approval. Varipulse Pro features a new pulse sequence that marks the next evolution of the pulsed field ablation (PFA) platform. The company said it designed the technology to improve procedural efficiency while reinforcing … [Read more...] about Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
MicroPort EP wins European approval for PFA catheter
MicroPort EP announced today that it received EU MDR certification for its PulseMagic pulsed field ablation (PFA) catheter. The China-based company designed its PFA catheter to enhance both flexibility and performance in electrophysiology (EP) procedures. MicroPort says that PulseMagic enables both high-density mapping and PFA through one … [Read more...] about MicroPort EP wins European approval for PFA 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
