European ACES Study Evaluates Svelte Medical's Acrobat Integrated Delivery System

December 20, 2012—Svelte Medical Systems, Inc. (New Providence, NJ) announced treatment of the first patient in the ACES (Acrobat Coronary Stent System Effectiveness European Study) clinical trial by Victor Legrand, MD, at CHU Liege in Liege, Belgium. ACES is a randomized, controlled study designed to demonstrate the clinical benefit and impact on resource utilization of the Svelte Acrobat integrated delivery system (IDS) compared with conventional coronary stent devices in patients with lesions eligible for direct stenting. Up to 300 patients will be enrolled in the study at 12 sites in France, Belgium, and Spain.

According to the company's press release, the Svelte IDS is designed to realize the clinical, time, and cost-saving benefits of direct stenting in a single platform. The Svelte coronary stent IDS is a fixed-wire-based system. It is navigated through the vasculature in a similar fashion to a traditional guidewire, allowing direct stenting of coronary artery lesions and eliminating several steps in current stenting procedures.

The Svelte IDS has a low profile and is highly flexible, facilitating use of the transradial approach and general downsizing of the access site while allowing access to more difficult-to-cross and distal lesions. The system also includes the company's balloon-control-band technology, which provides uniform and controlled balloon growth, even at high pressure, to safely facilitate direct stenting and use of the system for postdilatation. The company also plans to commercialize its drug-eluting stent on a conventional rapid-exchange delivery platform incorporating Svelte's balloon-control band.

The company advised that nonrandomized data presented at medical symposia earlier this year suggest the Svelte IDS significantly reduces radiation exposure, contrast use, adjunctive interventional product use, and overall procedure time when compared with conventional stent systems.

Jean Fajadet, MD, serves as principal investigator of the ACES Study. Dr. Fajadet, who is Director of Interventional Cardiology at Clinique Pasteur, Toulouse, France, commented on the device and the study in the company's press release.

“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,” stated Dr. Fajadet. “The ACES study will specifically assess patient and physician benefit and may become a reference study, given the increasing focus on healthcare costs. 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.”