NxStage Medical, Inc., has gained U.S. FDA clearance to market its System One™ to perform hemodialysis overnight while the patient is at home sleeping.
Vascular
GORE® VIABAHN® Endoprosthesis CE Mark Extended to Include Arteriovenous Access
New CE approval extends to the revision of dialysis access vessels.
Endurant ‘AAA’ Stent Graft Holding Up Well at Four Years
Study data suggest Medtronic’s Endurant AAA stent graft system for endovascular repair of abdominal aortic aneurysms, continues to deliver durable, consistent and proven outcomes.
FDA Clears ArtVentive EOS™ Vascular Occlusion Device
Vascular Occlusion just got a bit easier with the clearance of ArtVentive’s Endoluminal Occlusion Device.
Vial of 10 Gelatin Embolization Pledgets FDA Cleared for Tumour and AVM Use.
New Gel-Block 10x offers 10 pledgets in a vial as a configuration that enhances value and customer ease-of-use.
Novel Carotid Artery Revascularization Approach Yields Unprecedented Pivotal Data
Silk Road Medical’s ROADSTER IDE Study points to low 30 day stroke rate using novel flow-reversal approach to carotid angioplasty and stenting.
First in Man Use of MANTA™ Large Bore Vascular Closure Device
Essential Medical reports on the initial First in Man studies for its revolutionary MANTA Large Bore Vascular Closure device, which is designed to seal 18F large bore femoral punctures.
98.9% Vessel Closure at Six Months in VenaSeal™ Study
Covidien’s acquisition of Sapheon this summer is looking like a smart move as pivotal clinical study results at 6 months suggest it successfully treats symptomatic varicose veins.
2014 Prix Galien Award for Best Medical Technology goes to Stryker for Neuro Clot Remover
Stryker’s clever neuro blood-clot removal device has received the Prix Galien USA 2014 Award for Best Medical Technology.
Study Shows 41% Reduction in Restenosis with Zilver® PTX® Drug-Eluting Stent at Five Years
The biggest trial of a drug-eluting peripheral vascular stent has yielded impressive results out to five years when compared with balloon angioplasty or bare metal stents.
CE Mark for Cardiovascular Systems’ Stealth 360® Peripheral Orbital Atherectomy System
CSI’s Stealth 360 Peripheral Orbital Atherectomy System CE Marked and made available for Europe’s peripheral artery disease sufferers.
2-year Data Presented at VIVA: Veryan’s BioMimics 3D Helical Stent Looking Even More Promising
Veryan Medical is preparing to commercialize its 3D Helical stent shortly, all supported by some promising comparative data.
FDA Clears Covidien HawkOne™ Directional Atherectomy System for Peripheral Arterial Disease
Covidien says the HawkOne™ System strengthens its directional atherectomy platform with a versatile solution for the treatment of peripheral arterial disease.
Spectranetics to Acquire Stellarex™ Drug Coated Balloon Assets from Covidien
Spectranetics is to acquire Covidien’s Stellarex™ drug coated angioplasty balloon platform in a move that is likely to be part of the plan to meet anti-trust conditions related to next year’s takeover by Medtronic.
FDA Clearance of ReFlow Medical Wingman35 Crossing Catheter
ReFlow Medical, Inc. has gained FDA clearance for its Wingman35 Crossing Catheter for use in the peripheral vasculature as well as the first U.S. clinical cases with the device.
Bard Claims First and Only FDA-Approved Drug Coated PTA Balloon
The dream has become reality as Bard confirms approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty.