Svelte Medical Systems has treated the first patient in a randomized, controlled study using its fixed-wire based system, designed for treating patients with coronary artery lesions.
The low profile Svelte Acrobat Integrated Delivery System (IDS) facilitates use of the transradial approach and general downsizing of the access site, while allowing access to more difficult to cross and distal lesions.
Using the proprietary balloon control band technology, the system also provides uniform and controlled balloon growth, even at high pressures, to safely facilitate direct stenting and use of the system for post-dilatation.
The trial, named Acrobat Coronary stent system effectiveness European Study (ACES), will enroll 300 patients to compare the positive clinical benefit and impact on resource utilization of the Svelte IDS compared with conventional coronary stent devices in patients with lesions eligible for direct stenting.
Clinique Pasteur interventional cardiology director and study principal investigator Jean Fajadet said the study will specifically assess patient and physician benefit.
"The Svelte IDS is being used in our lab, and with appropriate patient and lesion selection, should offer reduced procedure time and cost, as well as reduced contrast use and radiation exposure, which is important to patients and physicians alike," Fajadet added.
"Once the DES version of the Svelte IDS is available, the system’s low profile will also become of greater benefit in treating more challenging and distally located lesions."
Svelte Medical Systems president and CEO Jack Darby said, "We look forward to the outcomes of the ACES study."