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# FDA OKs Boston Scientific’s Watchman FLX Pro
- URL: https://www.fdaweb.com/fda-oks-boston-scientifics-watchman-flx-pro/
- Published: 2023-09-06T12:00:00.000Z
- Updated: 2026-09-14T18:54:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155263

FDA has approved Boston Scientific’s latest generation of its Watchman FLX Pro Left Atrial Appendage Closure (LAAC) device, indicated for reducing stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy. The new device features a polymer coating, visualization markers, and a broader size matrix to treat a wider range of patients, according to the company.

Boston Scientific says the device’s coating is designed to reduce device-related thrombus and enable faster, controlled healing. Data from preclinical studies “demonstrated that the polymer coating provided an 86% reduction in inflammation three days following the procedure, a 70% reduction of thrombus at 14 days and a 50% increase in endothelial tissue coverage 45 days post procedure,” it adds.