Biotronik wins FDA approval for insertable cardiac remote monitor

Biotronik's BioMonitor 2--Courtesy of Biotronik

Biotronik scored FDA approval for its insertable cardiac remote monitor, giving the company a boost in a crowded market.

Regulators signed off on Biotronik's BioMonitor 2, a subcutaneous device that helps doctors flag and diagnose heart conditions including atrial fibrillation, ventricular tachycardia and fibrillation, and strokes. The product can also help monitor heart issues in patients who have already had ablation procedures, the company said in a statement.

Lake Oswego, OR-based Biotronik has already chalked up some positive data for its device. An Australian pilot study of BioMonitor 2 showed that the product could hold 60 minutes of electrocardiogram (ECG) recording time. The device can also send up to 6 subcutaneous ECGs daily through the company's home monitoring system.

"BioMonitor 2 simplifies the diagnosis of inconsistent and potentially life-threatening arrhythmias for physicians and patients," Biotronik President Marlou Janssen said in a statement. "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."

The device could be especially useful in preventing strokes, the company said. About 35% of strokes occur without a known cause, Mark Richards of Promedica Heart & Vascular said in a statement: "New diagnostic technologies, such as those found in the BioMonitor 2, can help manage these high-risk patients more effectively and efficiently."

Biotronik is not the only one working on new cardiac monitoring technology. Medtronic ($MDT) is developing the world's smallest insertable cardiac monitor implant, Reveal Linq. The company is setting the bar high for its product with $1 billion to $2 billion in expected annual sales.

- read the statement