Correction: The original version of this story misstated CardioMessenger's FDA status. It is 510(k) cleared.
Lake Oswego, Oregon-based Biotronik USA, the United States arm of Berlin-based medical device company Biotronik, has announced the launch of an FDA-cleared device that will add more portable cellular connectivity to its pacemakers, implantable cardiac defibrillators (ICDs), and insertible cardiac monitors (ICMs).
The device, called the CardioMessenger Smart, is about the size of an iPhone. It will take in data wirelessly from Biotronik's insertible and implantable devices, and transmit that data via a cellular connection to the patient's care provider via Biotronik's existing home monitoring framework. Previously, patients would need a landline-connected base station or a bulkier cellular unit, whereas CardioMessenger smart is small, secure, and automatic: it sends daily reports to a physician.
"The clinical and economic benefits of remote monitoring have been well established over a decade of clinical studies," Cleveland Clinic cardiologist Dr. Niraj Varma said in a statement. "But these benefits are only realized if patients consistently use the technology. When we make the remote monitoring process easy for patients, we increase the likelihood of patient adherence, which has been demonstrated to improve health outcomes."
A 2014 study in the Lancet, called the IN-TIME study, showed that home monitoring of implantable devices halved the mortality rate of cardiac patients. Two other studies, TRUST and COMPAS, have also shown value to Biotronik home monitoring.
"Biotronik pioneered modern wireless remote monitoring technologies in the year 2000 and we continue to invest in advancements that make life more enjoyable for patients living with cardiac conditions," Marlou Janssen, president of Biotronik, said in a statement. "The TRUST study demonstrated that Biotronik Home Monitoring delivers greater than 90 percent reliability of daily remote monitoring transmissions, providing more complete data for physicians to use in optimizing patient care. CardioMessenger Smart is Biotronik's latest home monitoring innovation that provides market-leading performance."