Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.
“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMonitor 2 simplifies the diagnosis of inconsistent and potentially life-threatening arrhythmias for physicians and patients. The easy insertion process and continuous wireless monitoring help ensure patient compliance while providing accurate data for physician diagnosis. This innovative technology further underscores Biotronik’s commitment to delivering cardiac technology that safely and effectively enables patients to live life to the fullest,” Biotronik prez Marlou Janssen said in prepared remarks.
The BioMonitor 2 is designed to be inserted under the skin of the patient, after which it records all cardiac electrical events, and transmits the data directly to a monitoring physician through the company’s Home Monitoring system.
“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. The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimizes risk of recurrent stroke. New diagnostic technologies, such as those found in the BioMonitor 2, can help manage these high-risk patients more effectively and efficiently,” Dr. Mark Richards of the Promedica Heart & Vascular Institute said in a prepared statement.
Last August, Biotronik said it won CE Mark approval in the European Union for its BioMonitor 2 subcutaneous insertable cardiac monitor and released results of a pilot study of the device. The company launched the devices in the U.K. and Ireland just last week.
The Australian pilot study reported an average insertion time of less than 2 minutes with a 90% success rate in sending transmissions to Biotronik’s home monitoring system, according to Berlin-based Biotronik.
The device is capable of over 60 minutes of electrocardiogram monitoring, according to Biotronik, and can send up to 6 ECG scans daily through the company’s home monitoring system.