DYNAGEN™DYNAGEN™ CRT-D - G154

These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

• Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms or
• Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

Indications, Safety, and Warnings