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# FDA Approves 2 Svelte Stent Systems
- URL: https://www.fdaweb.com/fda-approves-2-svelte-stent-systems/
- Published: 2021-12-14T12:00:00.000Z
- Updated: 2026-09-14T17:25:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150770

FDA has approved Svelte Medical Systems’ Slender IDS fixed-wire and Direct RX rapid-exchange drug-eluting stent systems to treat coronary artery disease. The company [says](https://www.marketwatch.com/press-release/svelte-medical-systems-receives-fda-approval-for-slender-ids-and-direct-rx-bioresorbable-coated-drug-eluting-stent-systems-2021-12-14?tesla=y&ref=fdaweb.com) the two systems, incorporating the same stent, bioresorbable drug coating, and balloon technologies, achieved 1.5% clinically-driven target lesion revascularization at one year in the OPTIMIZE IDE clinical study, the lowest ever reported with an investigational drug-eluting stent.