Brought to you by:
Bentley launches rebranded crossing catheter
Germany-based endovascular device company Bentley announced the launch of the BeBack crossing catheter—formerly known as the GoBack—designed for the treatment of heavily calcified lesions above and below the knee. Bentley acquired the catheter in September 2022 from Upstream Peripheral Technologies,…
Penumbra launches Lightning Flash mechanical thrombectomy system
Penumbra have announced the Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system. “Lightning Flash features Penumbra’s novel Lightning intelligent aspiration technology, now with dual clot detection algorithms,” the company notes in a press release,…
Endologix receives FDA approval of PMA supplement for AFX2 system
Endologix recently announced that it has received Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system. According to a company press release, Endologix received approval to include an updated warning and the…
Eastern Vascular gathering challenged to forge next generation of evolution
Evolution was the core theme of the Presidential Address Robert Rhee, MD, delivered from the Eastern Vascular Society (EVS) annual meeting stage in Philadelphia (Sept. 29–Oct. 1). “Let’s Evolve,” it was entitled. But, Rhee told those gathered, the society lays…
Chocolate Touch DCB for treatment of peripheral arterial disease receives FDA approval
Genesis MedTech Group announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed by TriReme Medical for the treatment of patients with peripheral arterial disease (PAD) in the…
Amplifi vein dilation system continues to show promise following latest first-in-human study update
An update from the first-in-human study assessing the Amplifi vein dilation system (Artio Medical) was delivered by Surendra Shenoy, MD, from Washington University School of Medicine in St Louis, during the first-ever late-breaking clinical trials session at this year’s Venous Endovascular…
Terumo Aortic announces new technology add-on payment for Thoraflex Hybrid device in US
The Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device—used to treat aortic arch disease—under the inpatient prospective payment system (IPPS). The add-on payment is effective…
No time like the present: The moral imperative for advocacy in vascular surgery
“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the typical reasons. Our patients’ blood pressure wasn’t sky high in pre-op, and our case wasn’t being…
TCAR: First patient enrolled in ROADSTER 3 post-approval study
Silk Road Medical has announced enrollment of the first patient in ROADSTER 3, which the company claims is the the first prospective, multicenter, single-arm study to assess real-world treatment of standard surgical risk patients with carotid artery disease using transcarotid…
AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system
AngioDynamics recently announced receiving Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy. The FDA recently cleared the expanded indication for the Auryon system’s 2mm and 2.35mm catheters to include adjacent…