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FDA approves Smartview remote monitoring system

FDA approves Smartview remote monitoring system

On 10 May, Sorin Group announced it received FDA approval for its Smartview remote monitoring solution for patients with implanted cardiac rhythm devices. The company also announced that is beginning the US launch of this new product.

The Smartview remote monitoring solution in conjunction with the Sorin Paradym RF device allows valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the Paradym RF VR and DR implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy (CRT-D) devices in the United States in May 2012.

According to a company release, Paradym RF devices are the only clinically proven ICDs that both reduce right ventricular pacing below 1%and offer the lowest recorded inappropriate shock rate 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.

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 patients.

“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 US 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.”