Svelte™ Medical Systems, Inc. Receives CE Mark Approval To Market The Svelte Acrobat Stent-On-A-Wire…
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Also Included In: Regulatory Affairs / Drug Approvals ; Clinical Trials / Drug Trials
Svelte™ Medical Systems, Inc. is pleased to foretell that it has formally standard the CE Mark to mart its Acrobat Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat SOAW stenting arrangement has been shown in clinical trials to help calculate stenting and has the potency to supply real adjective sentence and price savings. These savings are accomplished by eliminating the pauperization for a coronary guidewire and inflate distention catheters. Furthermore, the Acrobat stent allows rock-bottom use of line intermediate which is a welfare to many patients. Another significant reward when victimization the Acrobat stenting arrangement is that the manipulator and patient radioactivity dosing is importantly decreased. The super low crossbreeding visibility of the Acrobat stent makes it comfortably suitable for stenting via the stellate arteria overture which provides extra ease and prophylactic benefits to the patient.
Svelte’s President and CEO, Mark Pomeranz has declared that, “This is manifestly a well-nigh substantial milepost for the Company. We successfully terminated our First-In-Man (FIM) clinical evaluations at the end of July and with acknowledge of the CE Mark we bequeath be able-bodied to shuffle this exciting ware commercially uncommitted to a all-encompassing reach of physicians and patients. Distribution of the Acrobat stent inside the EU and Brazil testament get in September. We look convinced that the commercialize volition reply positively and that the Acrobat leave advance a important portion of the grocery for coronary stents.”
The Company plans to tyro U.S. clinical trials on the Acrobat SOAW engineering in 2011. A dose eluting variant of the Acrobat stent is now below growth exploitation a new non-inflammatory bearer for the dose.
To raise the impropriety with the Acrobat stent production for physicians, Svelte Medical Systems bequeath 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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