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Svelte Medical Systems, Inc. Announces FDA Approval to Initiate a Pivotal Study of Its Coronary Stent Integrated Delivery System (IDS)


10/22/2012 9:36:59 AM

NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Svelte® Medical Systems announced today it received conditional approval from the FDA to begin a pivotal study for the Svelte coronary stent Integrated Delivery System (IDS). Approved by the FDA under an Investigational Device Exemption (IDE), the study will evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigative sites in the US. “We are pleased to have earned approval from the FDA to initiate our pivotal study and look forward to collaborating with our clinical partners to demonstrate the clinical, procedural and cost savings benefits of our IDS technology,” said Jack Darby, President and CEO of Svelte. “Given the ever-increasing time constraints and cost pressures confronting cardiac cath labs, we are very confident the Svelte IDS offers an impactful alternative to maximize efficiency while providing best-in-class technology and outcomes.”

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