The European Union has given its nod of approval to Boston Scientific Corp. to introduce its Latitude remote-monitoring programme for heart-failure devices and defibrillators across the continent. The remote-monitoring system is already approved for use in the US.
The Latitude system remotely monitors patients with implantable cardiac devices, gathering information on both the device and a patient’s heart health status. The system can also detect clinical events between scheduled physician visits and send relevant data directly to a patient’s physician.
Boston Scientific said it earned CE-mark approval, which certifies that the product meets consumer-safety and health standards in Europe, where the market for heart-failure devices and defibrillators is estimated to be around $1.5 billion.
So far, the Latitude programme has been used for patients in the Netherlands and Denmark, and the company hopes to expand to 14 European Union countries in a phased approach.
Boston Scientific has enrolled more than 130,000 patients on the Latitude system since its introduction in the US in 2006, making it the most rapidly adopted remote cardiac device monitoring system in the industry, according to the company.
Analysts, according to the Wall Street Journal, say that no single US player in cardiac rhythm management has advanced far beyond the others in device function, so service aspects such as remote monitoring, sometimes called telemedicine, have the potential to help differentiate the companies. Boston Scientific, Medtronic Inc. and St. Jude Medical Inc. offer these programmes in the US.
