Svelte Medical Systems has treated the first patient in the ACES (Acrobat Coronary stent system effectiveness European Study) clinical trial.
ACES is a randomized, controlled study to show the clinical benefit and utilization of the Svelte Acrobat Integrated Delivery System (IDS) in comparison to conventional coronary stent devices in patients with lesions eligible for direct stenting.
The trial will enroll nearly 300 patients at 12 sites in France, Belgium and Spain, according to the company.
ACES study principal investigator Jean Fajadet said the Svelte IDS, with proper patient and lesion selection is expected to reduce procedure time and cost as well as reduced contrast use and radiation exposure.
"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," Fajadet added.
Svelte Medical Systems president and CEO Jack Darby 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."
The Svelte IDS, which includes proprietary balloon control band technology facilitates use of the transradial approach and general downsizing of the access site, while allowing access to difficult to cross and distal lesions.