InspireMD receives IDE approval from FDA for CGUARDIANS II pivotal trial

InspireMD has announced that the Food and Drug Administration (FDA) approval of the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm carotid stent system during transcarotid artery revascularization (TCAR) procedures.…
Silk Road celebrates milestone of 100,000 TCAR procedures

Silk Road Medical has announced the milestone of more than 100,000 transcarotid artery revascularisation (TCAR) procedures having been performed to date. “A growing number of patients come to us looking for a solution that is minimally invasive and requires less…
Boston Scientific announces agreement to acquire Silk Road Medical

Boston Scientific has announced that it has entered into a definitive agreement to acquire Silk Road Medical, a medical device company involved in producing products to be deployed during transcarotid artery revascularisation (TCAR). The purchase price is US$27.50 per share,…
Single-center analysis suggests improved longer-term outcomes with endarterectomy versus TCAR

A large, single-center analysis has found that, despite parity between the two procedures in terms of perioperative clinical outcomes, carotid endarterectomy (CEA) was associated with a reduced rate of late stroke/death compared to transcarotid artery revascularization (TCAR). Writing in the…
The top 10 most popular Vascular Specialist stories of November 2023

In November, the most read stories from Vascular Specialist include a reassessment of which carotid revascularization treatment modality is best after the recent Centers for Medicare & Medicaid Services (CMS) coverage expansion; updated analyses from the VOYAGER PAD clinical trial;…
More research needed but lithotripsy plus TCAR ‘an answer’ in certain carotid disease patients

Earlier this year, researchers debuted single-center experiences indicating that intravascular lithotripsy (IVL) may be able to expand transcarotid artery revascularization (TCAR) into patients with traditionally prohibitive calcific disease. With a multicenter case series now further suggesting IVL’s utility, but also…
DAPT linked to better post-TCAR outcomes versus other drug regimens

Dual antiplatelet therapy (DAPT) has demonstrated improved clinical outcomes, including reduced in-hospital stroke and mortality risks, compared to other medication regimens in carotid disease patients who undergo stent placement via a transcarotid artery revascularization (TCAR) procedure. This is the key…

