Svelte Medical Systems treated the 1st patient in its clinical study, evaluating the company’s Svelte Acrobat Integrated Delivery System in comparison with conventional coronary stent devices in treatment of patients with lesions eligible for direct stenting.
The Svelte coronary stent IDS is low profile and highly flexible, designed to streamline stenting and thereby reduce procedure time and cost, the company said.
"Demonstrating procedure time and cost savings in a randomized setting with enhanced clinical outcomes and operator ease-of-use will definitively establish the value of the Svelte IDS," president & CEO Jack Darby said in prepared remarks. "We look forward to the outcomes of the ACES study."
The study will enroll up to 300 patients at 12 sites in France, Belgium and Spain, according to the press release.
ACES study director Dr. Jean Fajadet said the system offers reduced procedure time and cost, as well as reduced contrast use and radiation exposure. The system will treat more challenging and distally located lesions once the DES version of the Svelte IDS is available.
The New Providence, N.J.-based medical device company recently won investigational device exemption from the FDA to launch a pivotal human trial of its coronary stent Integrated Delivery System.