Pivotal Study Approved by FDA for Svelte's Coronary Stent Integrated Delivery System

October 22, 2012—Svelte Medical Systems (New Providence, NJ) announced it received conditional approval from the US Food and Drug Administration to begin a pivotal study for the Svelte coronary stent integrated delivery system (IDS). The study, conducted under an investigational device exemption, will evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigational sites in the United States.

As detailed in the company's press release, the Svelte IDS combines a wire, balloon, and bare-metal stent into a single system. The low-profile and highly flexible IDS navigates through the vasculature similar to a traditional guidewire to allow physicians to “direct stent” coronary artery lesions and eliminate several steps from conventional stenting procedures, which would reduce procedure time and cost. The company stated that data presented at medical symposia suggest that the Svelte IDS significantly reduces radiation exposure, contrast use, adjunctive interventional product use, and overall procedure time when compared with conventional stent systems.

The IDS received CE Mark approval in 2010 and is commercially available in select European and Latin American markets.

The company also noted that it has completed enrollment in the DIRECT study, a first-in-man evaluation of its drug-eluting stent (DES), which uses a bioabsorbable drug carrier, and expects to initiate a European-based clinical study in support of its CE Mark approval later this year. When it is commercially released, this DES will be offered on both IDS and conventional rapid-exchange platforms incorporating the company's balloon control band technology.