A new diagnostic device for infrequent arrhythmias and syncope offers increased accuracy and detail in heart monitoring. The BioMonitor 2 from Biotronik was given FDA approval on Tuesday.
“The clinical and economic burdens of stroke are high and continue to grow. Prevention is necessary, yet more than 35 percent of strokes are cryptogenic and occur with no known cause,” said Mark Richards with the Arrhythmia and Cryptogenic Stroke Programs, at Promedica Heart & Vascular Institute. “The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimizes risk of recurrent stroke.”
The device detects and enables diagnosis for atrial fibrillation, ventricular tachycardia and fibrillation, and syncope, as well as being appropriate for patients who have had ablation procedures. It is implanted using local anesthesia, and is equipped with a flexible antenna for automatic wireless monitoring. It uses the same kind of technology used in other Biotronik products in order to make sure that patients can receive MRI scans even with the device implanted.
In total, the device is capable of more than 60 minutes of recording time and can transmit up to six subcutaneous EKGs per day. Biotronik helps to be able to simplify the kind of monitoring and diagnosis necessary for responding to arrhythmia. A pilot study found the device to have greater than 90 percent transmission reliability.
Biotronik is based in Berlin, Germany and manufactures cardiac systems.