EU Approves Cardiac Monitoring Device From Biotronik

Biotronik SE & Co. Kg has received the CE mark to introduce its CardioMessenger Smart device to the European market. It works with the company’s pacemakers and implantable cardioverter-defibrillators (ICDs) to share the implants’ status and patient cardiac data with physicians.

The device is fully automatic, passing the data via the GSM cellular network to physicians without any interaction from the patients. All that’s required is for the CardioMessenger Smart to be plugged in and within range of a GSM cellular signal anywhere in the world. The data is sent to the Biotronik Home Monitoring system on a daily basis, as well as whenever an abnormal cardiac event is detected, letting cardiologists focus immediately on the patients in need of attention.

“Home Monitoring alerts me to relevant changes in patient or device status, ensuring that I always see the right patient at the right time,” Volker Leonhardt, M.D., director of telemedicine at Pacemaker and ICD Center (HIZ), in Berlin, Germany, said in a statement. “I can keep track of each patient without subjecting him to needlessly intrusive in-person follow-ups and react quickly when necessary. This has clear clinical advantages for the patient, especially for heart failure patients, who according to the IN-TIME study benefit from a mortality reduction of more than 50 percent.”

Biotronik executives claim the CardioMessenger Smart is easy to set up. To enable daily, automatic wireless transmission of device data via the GSM cellular network, the patient simply needs to connect the device to a power source. Since the CardioMessenger Smart does not require connection to a landline, patients benefit from improved safety and greater peace of mind, whether at home or abroad. Additionally, its small and modern design fits inconspicuously into every home environment, without any disturbing sounds or lights, the company noted in a news release.

“Recent years have seen a shift towards early detection and prevention. By helping healthcare providers better manage their patients, Home Monitoring improves the efficacy and safety of cardiac rhythm therapy,” said Wolf Ruhnke, vice president of Biotronik. “Patient-centric advanced technologies like Home Monitoring allow implant patients to go about their lives with the peace of mind that comes from knowing they are taken care of, anywhere, anytime.”

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.