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Svelte Medical Systems wins investigational device exemption to launch a pivotal human trial of its coronary stent Integrated Delivery System.

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New Providence, N.J.-based Svelte Medical Systems won conditional approval from the FDA to launch a pivotal human trial of its Svelte coronary stent Integrated Delivery System, designed to streamline stenting and thereby reduce procedure time and cost.

Svelte won approval to enroll around 370 patients at up to 30 U.S. sites to evaluate the safety and effectiveness of its IDS, which combines a wire, balloon and stent into an all-in-one low-profile and highly flexible system.

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