Svelte Medical's Acrobat Coronary Stent System Receives CE Mark Approval

August 23, 2010—Svelte Medical Systems, Inc. (New Providence, NJ) announced that it has received CE Mark approval to market the Acrobat stent-on-a-wire (SOAW) bare-metal coronary stent system in the European Union.

According to the company, the Acrobat SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide shorter procedural time and substantial cost savings by eliminating the need for a coronary guidewire and balloon dilatation catheters. The Acrobat stent allows reduced use of contrast medium and significantly reduced radiation dosing. The low crossing profile of the Acrobat stent is suited for stenting via a radial artery approach for additional comfort and safety benefits to the patient.

Svelte Medical stated that its first-in-man clinical evaluations were concluded at the end of July and that the device will be commercially available in the European Union and Brazil in September. The company plans to initiate clinical trials in the United States on the Acrobat SOAW technology in 2011. A drug-eluting version of the Acrobat stent is under development using a novel noninflammatory carrier for the drug, the company advised.