A New Fixed-wire, ‘Stent-on-a-wire’, Very-low-profile Stent Delivery System – Rationale, Design and Update

Abstract

Coronary artery stenting has evolved substantially since the first use of coronary stenting as an adjunct to balloon angioplasty in the early 1990s. The performance (and particularly the deliverability) of coronary stents has improved such that coronary stenting is now the primary mode of revascularisation for percutaneous coronary interventions (PCIs) in more than 95% of cases. The new Svelte™ stent-on-a-wire (SOAW) delivery system represents one of the first substantive innovations in stent delivery systems (SDS) in more than a decade. This SDS uses a shapeable ‘fixed wire’ as an integral part of the SDS. This allows a significant reduction in SDS profile (~0.029 inches) compared with conventional monorail or over-the-wire SDS. This SOAW SDS is intended to facilitate direct stenting. It has the potential to provide substantial procedural cost savings by eliminating the need for a coronary guidewire and balloon pre-dilatation and/or post-dilatation, and by reducing contrast use and the time required to complete the procedure. The SOAW system is compatible with 5Fr guiding catheters, and may reduce the need for closure devices, facilitate stenting via the radial approach and (potentially) reduce bleeding risks. In conclusion, the Svelte SOAW SDS represents a new very-low-profile balloon-expandable SDS that should promote direct stenting in PCIs. The efficiency and small profile of this SDS may allow procedural cost savings, a reduction in procedure time and a reduced risk of bleeding complications. These theoretical advantages will need to be demonstrated in clinical trials.