FDA approves the listing of Medtronic's new defibrillator

FDA approves the listing of Medtronic's new defibrillator

Heart disease and stroke have been talked about. Studies have shown that symptoms of atrial fibrillation often occur before patients develop these diseases. Statistics show that patients with atrial fibrillation have five and three times the risk of stroke and heart failure, respectively. However, clinical trials still have great difficulty in detecting atrial fibrillation. Recently, the US FDA approved two Visa AF implantable cardioverter defibrillators (ICDs) introduced by Medtronic for the diagnosis and treatment of patients with new atrial fibrillation.

Similar to the current implantable cardioverter defibrillators in the US market, these two products are single-chamber defibrillators. These two products are scheduled to go on sale this summer.

According to Dr. Edward Schloss of The Christ Hospital in Cincinnati, USA, approximately 75% of patients have not been diagnosed with a history of atrial fibrillation before receiving ICD therapy. However, 20% of these patients were eventually diagnosed with the disease.

The two products approved by Medtronic will help doctors diagnose patients and treat them as soon as possible, thus minimizing the risk of more serious illness in patients. According to the company, the two ICD products use the latest algorithm to accurately detect abnormal fluctuations in heart rate, so that patients can be found to have signs of atrial fibrillation. This product has previously obtained CE certification.

Atrial fibrillation is a common type of tachyarrhythmia, and 1% of people over the age of 60 have atrial fibrillation, which increases exponentially with age. Among them, patients with no structural heart disease accounted for 3% to 11%. The Framingham study found that patients with atrial fibrillation had a 1.5 to 1.9-fold higher mortality rate than those without atrial fibrillation. The occurrence of atrial fibrillation is related to age and the type of underlying disease. Hypertension is the most common cardiovascular disease associated with atrial fibrillation. Patients with atrial fibrillation have a significantly increased risk of embolic complications.

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