Balloon Catheterization
Vascular closure system utilizing plant-derived hemostatic foam gains FDA clearance
KOAG LLC, a Minneapolis-based medical device firm, announced it received FDA clearance for its topical vascular closure system.
FDA designates recall of two coronary dilatation catheters as class 1
The FDA has designated Abbott Vascular’s product recall of two coronary dilatation catheters as a class 1 recall, the most serious kind. The recall affects 13,891 devices distributed between August and January.
Low-dose paclitaxel-coated balloon noninferior to higher-dose balloon
A low-dose paclitaxel-coated balloon was similar in safety and efficacy to a higher-dose one for treatment of patients with peripheral artery disease, according to the full 1-year results of the COMPARE trial.
DCB remains superior to PTA at 1 year in treatment of arteriovenous fistula lesions
A drug-coated balloon was superior to percutaneous transluminal angioplasty at 1 year for primary patency and clinically driven target lesion revascularization in patients with de novo or restenotic arteriovenous fistula lesions, according to new data from the IN.PACT AV Access study.