Svelte Medical Systems (New Providence, NJ) announced that it had successfully completed enrollment in its DIRECT II drug-eluting stent clinical study. The trial is designed to study the safety and efficacy of the company’s drug-eluting coronary stent Integrated Delivery System (IDS) in comparison with the Medtronic Resolute Integrity drug-eluting stent. The study will comprise 159 patients and will take place at 19 sites.
The Svelte drug-eluting stent IDS is designed to navigate a patient’s vasculature in a way that is similar to traditional guidewires. That said, the new stent allows for the use of a transradial approach. The device comprises a new type of bioabsorbable drug carrier material made from amino acids (PEAs). In comparison with PLGA technologies, PEAs elicit less of an inflammatory response. The drug carrier material is with filled sirolimus (rapamycin), a commonly-used compound. The new device also includes a thin-strut cobalt chromium stent.
The system also features Balloon Control Bands (BCBs) that envelop balloon shoulders, allowing for a smooth leading edge during device delivery. In addition, the bands can help ensure controlled balloon growth during deployment, allowing for safe direct stenting and high-pressure post-dilation.
“Our IDS and RX systems are uniquely designed to facilitate use of the transradial and direct stenting approach to PCI, two segments of the market which are not currently served by dedicated technologies, yet have demonstrated significant clinical benefits and procedural efficiencies which are critical in today’s healthcare landscape,” stated Jack Darby, CEO and president of Svelte Medical Systems.