The Sorin Group Introduces a New Line of Cardio Devices

The Sorin Group has announced U.S. Food and Drug Administration (FDA) approval and the commercial launch of the Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices. The company, headquartered in Milan, Italy, made the announcement at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd Annual Scientific Sessions. These new heart devices are designed to be monitored remotely.

The Paradym RF line offers Sorin’s proprietary SafeR and Parad+ algorithms that automatically adjust to each individual patient to minimize right ventricular (RV) pacing and inappropriate shocks. According to the company, Paradym devices are the only clinically proven ICDs that both reduce RV pacing below one percent and offer the lowest recorded inappropriate shock rate of any devices available to date.

The new devices are designed to provide patients with a combination of thinness, high power and longevity. The battery and capacitor technology in the devices deliver 37J of energy with longevity over six years and nine years respectively in a device only 11 mm thick, the company claims.

The Paradym RF CRT-D also features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation, a common side effect of cardiac resynchronization therapy. In addition, the CRT-Ds also include Sorin’s proprietary Brady-Tachy Overlap algorithm that provides pacing therapy during exercise while maintaining the ability to detect and treat slow ventricular arrhythmias.

“The combination of features offered within the Paradym RF devices will be appreciated by many United States physicians who treat patients at risk of sudden cardiac arrest, including some whose heart failure can be managed by cardiac resynchronization therapy,” said Freddy Abi-Samra, M.D., from the Ochsner Medical Center, New Orleans, La. 

The Sorin Group focuses on three areas of the cardiovascular device market: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement.