Svelte Medical Systems has announced the start of enrolment in the DIRECT III post-market registry study. DIRECT III is an “all-comer” study in Europe undertaken to evaluate the procedural efficiency and long-term safety of the Slender IDS, which a press release reports is the first advance in stent delivery since the rapid-exchange catheter. According to the press release, the device is the world’s lowest profile drug-eluting stent—reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial interventions in more patients.
DIRECT III will enrol up to 1,000 patients in six countries. Access site size, bleeding complications, overall procedure and fluoroscopy time, contrast administration and adjunctive product use will be assessed in all patients, while the first 250 patients will additionally receive clinical follow-up through one year. DIRECT III follows upon findings from the DIRECT II randomised, controlled study and previously published registry studies using a bare-metal version of the IDS in which reductions in procedure time, fluoroscopy exposure, contrast administration and material use were observed.
The press release notes that the DIRECT I and II clinical studies have demonstrated exceptionally low clinical event rates, with no deaths or stent thromboses reported through four years. Slender IDS is indicated for use with direct stenting and in diabetic patients, and is commercially available in Europe. Both Slender IDS and Direct RX, a rapid-exchange platform designed for direct stenting and using the same drug-eluting stent and balloon technology, will be evaluated next year in the OPTIMIZE study in support of PMA and PMDA approvals.
Giovanni Amoroso (principal investigator of the DIRECT III study, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands) comments: “Slender IDS is a new approach to coronary stenting, offering unique capabilities which I have integrated into my regular practice to benefit patients. Vessel trauma with transradial interventions is always a concern, especially in the elderly and patients of smaller stature. The ultra-low profile of Slender IDS allows me to downsize catheters without compromise to back-up support and performance, making for more slender and streamlined interventions, and ultimately, happier patients.”
Incorporating Asahi guide wire technology, a specialised balloon design and DISCREET (a new class of bioresorbable drug coating), Slender IDS is designed to enhance direct stenting, enabling interventional cardiologists to extract steps, time and cost from stenting procedures.