With the U.S. approval of two new wireless devices from St. Jude Medical, pacemaker users may no longer have to see the doctor for follow-up visits. The Accent RF Pacemaker and Anthem RF CRT-P (Cardiac Resychronization Therapy Pacemaker) have been approved by the U.S. Food and Drug Administration. The two cardiac devices use wireless communication to transmit data between the device and a remote monitor. Data from a home monitor can be captured and sent to the clinician for viewing via an online patient management system. Clinicians can perform follow-up visits without ever seeing the patient.
The patient management system, dubbed Merlin.net PCN (Patient Care Network), also received FDA and European CE Mark approval. Physicians can monitor disease progression and receive notifications of patient health alerts. The Accent and Anthem devices can be programmed to automatically notify doctors of conditions such as atrial tachycardia and atrial fibrillation. Both devices can also be programmed to automatically adjust the amount of electrical energy used to regulate the heart.
According to a new report by ABI Research, about 15 million wireless “telehealth” devices will be in use by 2012. Some companies trying to break into this market include Transoma Medical (cardiovascular monitoring), CardioMEMS (wireless sensor for use in treating abdominal aortic aneurysms), MicroTransponder (wireless neurostimulation for chronic pain), Sicel Technologies (monitoring changes in patient cells), Triage Wireless (blood pressure monitor), and NewCare Medical (vital signs monitoring).