Sorin Group Announces FDA Approval and U.S. Launch OF SMARTVIEW Remote Monitoring Solution for Patients with Implanted Cardiac Defibrillators
DENVER--(BUSINESS WIRE)--May 10, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), 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 PARADYM TM RF device can access valuable cardiac data and alert messages from the device while the patient is at home. Sorin launched the PARADYM TM 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 percent 1, 2 and offer the lowest recorded inappropriate shock rate 3 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 patients 4.
“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.”
1 “AAIsafeR preserves ventricular activity in case of Paroxysmal AV Block while maintaining ventricular pacing below 0.1% in 28/35 (80%) of non-selected DDD patients” p. S246, Anselme, F., et al. First clinical results of AAIsafeR2, a new mode to prevent ventricular pacing. Heart Rhythm 2005; 2, supp 5; p4-99 (abs).
2 With SafeR mode
3 Anselme, F., et al: Prevention of Inappropriate shocks in ICD Recipients: A review of 10000 Tachycardia Episodes. PACE, Vol 30, January 2007, Supplement 1. Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms
4 Remote monitoring of Sorin’s implantable cardiac devices with SMARTVIEW is based on physician instructions.
SMARTVIEW is not a substitute for appropriate medical attention and should only be used as directed by a physician
About Sorin Group
Sorin Group ( www.sorin.com ) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.
For more information, please visit www.sorin.com.