The pacemaker has the function of resynchronizing the heart and is compatible with MRI - Vietnam Registration 2402754ĐKLH/BYT-HTTB

The intended purpose The cardiac resynchronization therapy defibrillator (CRT-D) is a surgically implanted device designed to be used for an extended period of time to monitor and regulate the heart rhythm of the patient. These devices receive the intrinsic electrical activity through the cardiac leads' electrodes, analyze the heart rhythm based on the programmed sensing parameters, and perform resynchronization therapies to treat the condition of chronic heart failure and heart block. Indications The Solara Quad CRT-P MRI SureScan Model W4TR06/ Solara CRT-P MRI SureScan Model W1TR06 system is indicated for use in patients with heart failure and one or more of the following conditions: • Abnormality of the heart's electrical conduction with a prolonged QRS interval • Reduced ejection fraction (EF), regardless of the degree, as defined by the New York Heart Association (NYHA), and who are indicated for ventricular resynchronization and have a high degree of atrioventricular (AV) block • Reduced EF and who have all of the following: – A history of having a conventional pacemaker or ICD implanted previously – A worsening of heart failure despite optimal medical therapy – A high rate of RV resynchronization Frequency-adaptive resynchronization therapy is performed in patients who may benefit from the increased frequency response capability when increased exercise is performed The atrial and dual-chamber monitoring modes are indicated for patients who may benefit from maintaining AV synchrony.