A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported the enrollment of the first patient in the SONOMA post-market approval study of the company’s NexStent carotid stent system used in conjunction with the FilterWire EZ embolic protection system.
The objective of the study is to confirm the real-world safety and efficacy of the NexStent carotid stent system and FilterWire EZ embolic protection system in routine clinical practice.
“This study represents one of the few multi-center studies in which shorter-term and longer-term clinical outcomes of carotid artery stenting placement will be reported,” said Subbarao Myla, MD, principal investigator of the study.
The FDA has approved the NexStent and FilterWire EZ for use in patients with carotid artery disease who are at high risk for surgical carotid endarterectomy.
The NexStent includes a laser-cut, nitinol stent with a rolled sheet design that enables one stent size to adapt to multiple diameters in tapered or non-tapered vessel configurations. Its self-sizing feature is intended to provide customization when treating lesions in the carotid arteries, while its closed-cell configuration is designed to increase lesion coverage and to provide a smooth inner lumen to help facilitate delivery and retrieval of ancillary devices.
The FilterWire EZ Embolic Protection System is designed to efficiently capture plaque and other material that may dislodge during stent implantation, thereby reducing the risk of procedural-related stroke or heart attack.