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FDA approves expanded indications for TCAR’s Enroute stent
The Food and Drug Administration (FDA) approved expanded indications for the Enroute stent system—part of the transcarotid artery revascularization (TCAR) procedure—to include patients at standard risk for adverse events from carotid endarterectomy (CEA), Silk Road Medical announced today. Previously, the…
Terumo Aortic announces FDA approval for Thoraflex Hybrid frozen elephant trunk device
Terumo Aortic today announced that the Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk device for commercial sale in the U.S. for the treatment of patients with complex aortic arch disease. Thoraflex Hybrid…
Shockwave Medical announces global launch of new peripheral IVL catheter
Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both Food and Drug Administration (FDA) and CE mark clearance. A company press release details that the Shockwave M5+ catheter is specifically designed to…
Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system
Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the Food and Drug Administration (FDA), a press release reports. The company details that, while the product is not commercially available yet, the benefits of the designation…
Database analysis findings ‘matched precisely’ with reported reasons for venous stent recalls
A recent analysis recalled Venovo and Vici venous stents—initiated last year—characterized “significant differences” between reported device and patient issues, and subsequent interventions for the two systems, with findings ultimately matching the reasons given for the recall at the time. A…
Ra Medical Systems receives FDA approval for increased enrollment in atherectomy clinical trial
Ra Medical Systems, a medical device company focused on developing the excimer laser system to treat vascular diseases, has announced that enrollment has reached 95 subjects in the pivotal clinical trial to evaluate the safety and effectiveness of the DABRA…
FDA issues guidance documents for including patient perspectives in medical device studies
The Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies. As per an FDA press release, the finalized version of the first of these two guidance documents,…
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI). The Breakthrough…
Philips integrates cloud-based AI and 3D mapping into its mobile C-arm system series
Royal Philips has announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system—Zenition. The system will deliver enhanced clinical accuracy and efficiency, according to Philips, and aims to improve outcomes…
Our forever plague
The following is a combined and revised version of the November and December 2021 editorials on fake news and science denial published in Vascular Specialist. Supplemental information and resources have been added to assist physicians in combating science denial and…