Stentys SA: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Stentys SA Receives FDA Approval To Initiate First U.S. Clinical Trial With Self-Apposing Stent
Stentys SA announced that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to conduct a pivotal clinical trial in the United States which, if successfully completed, will enable the Company to apply for marketing approval of the STENTYS Self-Apposing stent. Under this FDA-approved IDE, up to 880 heart attack (ST-elevation myocardial infarction or STEMI) patients at 50 sites in the U.S. and worldwide will be enrolled in the APPOSITION V clinical trial. The randomized trial is designed to compare the clinical outcome of patients treated with the bare metal STENTYS Self-Apposing Stent versus the stent already approved for use in this indication, the Abbott Multi-Link Vision stent, at 12 months after the procedure. The trial is expected to begin in early 2013. During a heart attack treatment procedure, the presence of a clot and the natural vessel contraction prevent cardiologists from determining the artery diameter with certainty. When selecting a conventional stent size, there is a risk of under sizing, causing malapposition, or oversizing, causing vessel wall injury; either leads to increased risk of heart attack recurrence. The STENTYS Self-Apposing Stent is designed to address that `stent sizing dilemma` by fitting into the contour of a blood vessel. The shape and diameter of the stent adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase.
Latest Developments for Stentys SA
- Stentys SA Announces Positive Results of Its OPEN II study of Self-Apposing Stent
- Stentys SA Sirolimus-Eluting Stent Demonstrates Faster Arterial Healing Than Conventional Drug-Eluting Stent
- Stentys SA Receives Approval to Expand CE Mark Indications of Its Self-Apposing Stent-DJ
- Stentys SA Announces Positive Interim Results of APPOSITION III Clinical Trial of STENTYS Self-Apposing Stents
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