FDA Approves Sorin Smartview Remote Monitoring Solution

Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with implanted cardiac rhythm management (CRM) devices.

Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the PARADYMTM RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices in the United States in May 2012.

PARADYM™ RF devices are the only clinically proven ICDs that both reduce RV pacing below one percent1, 2 and offer the lowest recorded inappropriate shock rate3 of any devices available to date. The addition of remote monitoring to the PARADYM™ RF family of devices provides a powerful combination of advanced diagnostic capabilities, early detection of cardiac disease progression, and patient convenience.

Installation of the SMARTVIEW remote monitoring system at the patient’s home is assisted by a dedicated helpdesk provided by Sorin. This unique technical set-up assistance provides patients with peace of mind and removes the installation workload from healthcare professionals. Once the system is installed, patients use the SMARTVIEW system to transmit data electronically from their implanted cardiac device to their physicians.

Using the patient data transmitted from home, healthcare providers will have access to the most current information from their patients’ device, which may help detect potential health issues before they become life-threatening and provide timely therapy. For some patients, this may mean fewer office visits and less time traveling to and from their clinics, and will help increase efficiencies in clinicians’ management of a growing number of device patients4.

“The introduction of SMARTVIEW remote monitoring in the United States is an important milestone for Sorin as we seek to extend our innovative technology offerings to more U.S. healthcare providers and patients,” said Stefano Di Lullo, President, CRM Business Unit, Sorin Group. “We believe our intelligent devices and first-rate remote monitoring capabilities and service will continue to help us grow our business in the United States while, most importantly, saving lives and improving patient symptoms.”