Svelte™ Medical Systems, Inc. Receives CE Mark Approval To Market The Svelte Acrobat Stent-On-A-Wire (SOAW) Coronary Stent System

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 25 Aug 2010 - 1:00 PDT

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Svelte™ Medical Systems, Inc. is pleased to announce that it has officially received the CE Mark to market its Acrobat Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters. Furthermore, the Acrobat stent allows reduced use of contrast medium which is a benefit to many patients. Another important advantage when using the Acrobat stenting system is that the operator and patient radiation dosing is significantly reduced. The extremely low crossing profile of the Acrobat stent makes it well suited for stenting via the radial artery approach which provides additional comfort and safety benefits to the patient.

Svelte's President and CEO, Mark Pomeranz has stated that, "This is obviously a most significant milestone for the Company. We successfully concluded our First-In-Man (FIM) clinical evaluations at the end of July and with receipt of the CE Mark we will be able to make this exciting product commercially available to a broad range of physicians and patients. Distribution of the Acrobat stent within the EU and Brazil will commence in September. We feel confident that the market will respond positively and that the Acrobat will gain a significant share of the market for coronary stents."

The Company plans to initiate U.S. clinical trials on the Acrobat SOAW technology in 2011. A drug eluting version of the Acrobat stent is now under development using a novel non-inflammatory carrier for the drug.

To enhance the familiarity with the Acrobat stent product for physicians, Svelte Medical Systems will be exhibiting at the European Society of Cardiology (ESC) Congress in Stockholm, Sweden August 28 - September 1st.

Source:
velte™ Medical Systems, Inc.

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