Penumbra (NYSE:PEN) announced today that it received CE mark approval for its Thunderbolt thrombectomy system for stroke. European approval for the computer-assisted vacuum thrombectomy (CAVT) technology comes just days after FDA clearance. Thunderbolt expands the company’s computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to … [Read more...] about Penumbra earns CE mark for Thunderbolt thrombectomy system
Regulatory
Penumbra wins FDA clearance for Thunderbolt computer-assisted vacuum thrombectomy for stroke
Penumbra (NYSE:PEN) announced today that it received FDA clearance for its Thunderbolt thrombectomy platform for stroke. Thunderbolt expands the Alameda, California-based company's computer-assisted vacuum thrombectomy (CAVT) portfolio. It aims to address acute ischemic stroke. Penumbra said Thunderbolt represents a first-of-its-kind … [Read more...] about Penumbra wins FDA clearance for Thunderbolt computer-assisted vacuum thrombectomy for stroke
Gore wins CE mark for Fortegra venous stent
W.L. Gore & Associates announced today that it received CE mark approval for its Viabahn Fortegra venous stent system. European approval comes about six months after the stent picked up FDA approval. The company labeled Viabahn Fortegra the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and … [Read more...] about Gore wins CE mark for Fortegra venous stent
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
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
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
