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Boston Scientific recalls Carotid Wallstent Monorail devices over ‘manufacturing defect’
Boston Scientific has recalled its Carotid Wallstent Monorail endoprosthesis owing to a “manufacturing defect” that has led to devices having an inner lumen that is smaller than specifications, causing resistance when withdrawing the stent delivery system. A Food and Drug…
ROADSTER 3 provides key evidence that ‘goes beyond registry data’ on TCAR-related stroke rates
Thirty-day results from the ROADSTER 3 study have demonstrated that transcarotid artery revascularization (TCAR) is a safe and effective approach in patients who are deemed to be standard risk for experiencing adverse events related to carotid endarterectomy (CEA). These findings…
Boston Scientific to acquire IVL developer Bolt Medical
Boston Scientific has announced it has entered into a definitive agreement to acquire Bolt Medical, the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for the treatment of coronary and peripheral artery disease. “Representing one of the fastest growing…
Boston Scientific completes acquisition of Silk Road Medical
Boston Scientific announced the close of its acquisition of Silk Road Medical, the company behind transcarotid artery revascularization (TCAR). “The integration of the TCAR platform into our portfolio means we can offer a treatment option for patients suffering from carotid artery disease that…
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,…
REAL-PE demonstrates statistically significant lower major bleeding rates with Ekos system compared to mechanical thrombectomy for PE treatment
Data from the REAL-PE study were presented this week at TCT 2023 (23–26 October, San Francisco, USA) demonstrating that patients treated for pulmonary embolism (PE) with the Ekos endovascular system (Boston Scientific) had lower rates of adverse events, including statistically…
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…
One-year results show ‘superior’ primary patency rate for Eluvia DES compared to bare metal stents
One-year results presented at Vascular Interventional Advances (VIVA) 2021 in Las Vegas (Oct. 5–7) from the EMINENT trial demonstrated the superiority of the Eluvia drug-eluting stent (DES) system (Boston Scientific) compared to self-expanding bare metal stents for the treatment of…
Two-year Ranger DCB data demonstrate ‘sustained, high rate’ of device efficacy
Patients treated with Boston Scientific’s Ranger drug-coated balloon (DCB) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year results from the RANGER II SFA randomized controlled trial have demonstrated, investigators revealed during a late-breaking session…
Boston Scientific and BD initiate venous stent recalls
Boston Scientific and BD have both initiated recalls of venous stents. According to a Food and Drug Administration (FDA) medical device recall notice posted May 21, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and Vici RDS…