FDA approves EBR Systems' WiSE CRT System for commercial distribution in US

EBR Systems, Inc.

FDA approved WiSE CRT System for left ventricular endocardial pacing; target initial US addressable market ~$3.6B.
Indicated for previously untreatable (failed CS lead) and high-risk upgrade patients aged ≥22.
Limited market release in late 2025; full commercial launch expected early 2026.
Post-approval study of 320 patients over 5 years required; NTAP/TPT reimbursement effective Oct 1, 2025.
Contraindications include triple anticoagulant therapy and allergy to procedural agents.

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