Tag: FDA approval

aneurysm

FDA approves MicroVention’s lower-profile WEB 17 intrasaccular aneurysm treatment device

The US Food and Drug Administration (FDA) has granted premarket approval (PMA) for the Woven EndoBridge (WEB) 17 system from MicroVention, a US-based subsidiary...

Surmodics’ Pounce thrombus retrieval system gains FDA 510(k) clearance

Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system. The company describes the Pounce system...
STAND

First case completed in STAND study, the pivotal clinical trial of...

Micro Medical Solutions has announced the first implantation of the MicroStent vascular stent in the US Food and Drug Administration (FDA) randomised, multicentre pivotal...
Tack

Tack Endovascular System receives FDA approval for below-the-knee post-angioplasty dissection repair

Intact Vascular has received US Food and Drug Administration (FDA) approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision...
natural

Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding...

Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and...

Philips receives FDA approval for low-dose drug-coated balloons

Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...
Lutonix

BD receives FDA approval for expansion to drug-coated balloon product line

The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery...
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...