Svelte Medical System touts 5-year follow-up of 1st drug-eluting stent-on-a-wire
Svelte Medical System presented 5-year outcomes today from the Direct 1st-in-man study of its drug-eluting coronary stent-on-a-wire delivery system in patients undergoing percutaneous coronary intervention.
The company reported no clinically-driven target lesion revascularization, target vessel failure or major adverse cardiac events.
“Longer-term follow-up of novel coronary stents is very important, as shown by the recent findings of unexpectedly high rates of very late thrombosis in bioresorbable scaffolds. The absence of late adverse clinical events through 5 years is unusual in any stent study. Considering half of the lesions treated in Direct were type B2/C and 97% device success was achieved despite all investigators being 1st-time operators with the system, I am very impressed with these results,” principal investigator Mark Webster said in prepared remarks.
The company also reported positive results from the 3-year Direct II study, which enrolled 159 patients. The trial compared the safety and efficacy of the Svelte system and Medtronic’s Resolute Integrity drug-eluting coronary stent.
In patients treated with Svelte’s system, 3-year major adverse cardiac events stayed consistent with 1-year results at 3.7%. In the control arm, the rate increased from 7.8% to 9.8%. Neither group had reports of stent thrombosis over the 3-year study period.
“The long-term results observed in the Direct and Direct II studies, coupled with no reports of stent thrombosis now through 5-years, indicate our technologies provide excellent and sustained patient outcomes,” president & CEO Jack Darby said in prepared remarks. “Our unique approach to stent delivery and bio-friendly drug coating allow physicians to streamline PCI and achieve best-in-class results, delivering both clinical and economic value to the healthcare system. We look forward to serving more patients and physicians around the globe.”
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