The top 10 most-read Vascular News stories in June featured two US Food and Drug Administration (FDA) investigational device exemption (IDE) approvals, Boston Scientific’s announcement that it will acquire Silk Road Medical, and a series of highlights from this year’s Vascular Annual Meeting (VAM 2024; 19–22 June, Chicago, USA).
1. AVS receives IDE approval from US FDA for pivotal intravascular lithotripsy study
Amplitude Vascular Systems (AVS) announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to begin its pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy.
Bijan Modarai (London, UK), professor of vascular surgery at King’s College London and a consultant vascular and endovascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust, spoke to Vascular News about his career so far.
AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) is a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behaviour when used with elective endovascular aneurysm repair (EVAR).
4. Boston Scientific announces agreement to acquire Silk Road Medical
Boston Scientific revealed 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, reflecting an enterprise value of approximately US$1.16 billion.
5. Xeltis receives IDE approval from US FDA for haemodialysis vascular access conduit
Xeltis announced that it has gained approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.
6. Baylis Medical Technologies announces first commercial use of PowerWire Pro for in-stent restenosis
Baylis Medical Technologies announced the completion of its first clinical use of the PowerWire Pro radiofrequency (RF) guidewire to safely cross a chronically occluded peripheral stent. The procedure was performed in April 2024 by Mark Iafrati (Vanderbilt University Medical Center, Nashville, USA).
A recent study suggests that endovascular treatment of the common femoral artery (CFA) is associated with an increased rate of long-term CFA-specific reintervention, regardless of indication. Nicholas Wells, a medical student at Yale School of Medicine in New Haven, USA, presented this and other key findings from a tertiary care centre analysis of open and endovascular treatment of the CFA at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA).
8. New data on TAMBE outcomes in complex aortic aneurysms revealed
The US Food and Drug Administration (FDA)-approved Gore Excluder Thoracoabdominal Branch Endoprosthesis (TAMBE) has been shown to be safe and effective at 30 days for the treatment of patients with complex aortic aneurysms involving the visceral aorta.
A study examining outcomes between different carotid revascularisation procedures has concluded that transcarotid artery revascularisation (TCAR) and carotid endarterectomy (CEA) both represent a “reasonable choice” in severe chronic kidney disease (CKD) and haemodialysis patients—but transfemoral carotid artery stenting (TF-CAS) appears more likely to result in worse outcomes.
10. Cook Medical announces Beacon sizing tip catheter availability in USA and Canada
Cook Medical shared that Beacon tip sizing catheters are now available in the USA and Canada. The Beacon catheter is available in a variety of lengths and tip configurations, a recent press release adds.
