The US launch of a new peripheral intravascular lithotripsy (IVL) catheter, new data on large bore mechanical thrombectomy in high-risk pulmonary embolism (PE) patients, and changes to the EU Medical Devices Regulation (MDR) caught readers’ attention in March.
1. Shockwave Medical announces US launch of new peripheral IVL catheter
Shockwave Medical today announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food and Drug Administration (FDA).
2. ACC 2023: Large bore mechanical thrombectomy reduces adverse outcomes in high-risk PE patients
Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the American College of Cardiology (ACC) 2023 Scientific Sessions (4–6 March, New Orleans, USA) indicate.
3. EU ministers approve changes to MDR transition timetable
The European Union’s Council of Ministers has adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).
Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischaemia and a 15% reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT).
5. Distal embolic protection linked to significantly better outcomes in carotid stenting
Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection during carotid stenting, and supporting the notion that, “if a filter cannot be placed safely, an alternative approach to carotid revascularisation should be considered”.
Recruitment is now complete with more than 100 patients as planned per protocol in the branched endovascular aneurysm repair (BEVAR) study that uses Bentley’s BeGraft peripheral Plus balloon expandable covered stent as a bridging stent in complex aortic aneurysms repairs.
Results from the PROMISE II pivotal trial investigating transcatheter arterialisation of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischemia (CLTI) patients were today published in the New England Journal of Medicine (NEJM).
8. Getinge receives US FDA premarket approval for the iCast covered stent system
Getinge‘s iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
ReCor Medical and its parent company, Otsuka Medical Devices, recently announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise ultrasound renal denervation (uRDN) system successfully reduced blood pressure compared to sham. In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Results of the pooled analysis showed a consistent blood pressure lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension.
10. Viz.ai receives FDA 510(k) clearance for abdominal aortic aneurysm AI algorithm
Viz.ai recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of suspected AAA, the company claims.
