The Svelte device elutes the anti-stenosis drug sirolimus using a bioabsorbable carrier made of Amino Acids, unlike the polymer-based drug carrier used in the Resolute stent.
The 159-patient Direct II study is slated to enroll subjects at up to 20 clinical sites in Europe and Brazil, with primary endpoints of target vessel failure and in-stent late loss. Patients will receive 6-month clinical and angiographic follow-up and further monitoring for 5 years.
“We are excited to have the Direct II study underway and wish to thank our outstanding group of investigators for their collaboration in this effort,” president & CEO Jack Darby said in prepared remarks. “We believe our drug-eluting IDS, with its proprietary balloon and drug carrier technologies, represents an easy to use, best-in-class offering which will deliver procedural efficiencies and associated cost savings while demonstrating long-term clinical outcomes consistent with market-leading drug-eluting stents.”