Tag: FDA approval

chocolate

Atherectomy included in pivotal study of QT Vascular’s Chocolate Touch DCB

The FDA has granted approval to include the use of atherectomy for lesion preparation in its ongoing US pivotal study of the Chocolate Touch...
Lutonix

BD’s Lutonix 018 DCB approved by FDA to treat SFA disease

The FDA has granted approval for BD’s 0.018-inch guidewire-compatible Lutonix 018 drug-coated balloon (DCB) for the treatment of long superficial femoral artery lesions in...
Rivaroxaban

Rivaroxaban receives peripheral arterial disease indication in Europe and USA

Rivaroxaban (brand name Xarelto, Bayer) has received approval from the US Food and Drug Administration (FDA) and the European Commission to reduce risks in...
ProVu

Acessa Health wins FDA nod for 3rd generation ProVu

Acessa Health has announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its third generation Acessa ProVu radiofrequency ablation...