FDA grants conditional approval to Sorin cardiac resynchronisation therapy system

21 March 2013 (Last Updated March 21st, 2013 18:30)

The US Food and Drug Administration (FDA) has granted conditional approval to Sorin Group to conduct an investigational device exemption (IDE) clinical study of its heart failure management system.

The US Food and Drug Administration (FDA) has granted conditional approval to Sorin Group to conduct an investigational device exemption (IDE) clinical study of its heart failure management system.

Sorin Group's SonR cardiac resynchronisation therapy (CRT) optimisation system, which is designed to automatically adjust on a weekly basis, consists of a SonR hemodynamic sensor, embedded in a SonRtip atrial pacing lead, and the Paradym RF SonR CRT-D device.

The Paradym device includes an algorithm that automatically optimises the patient's atrioventricular (AV) delay and interventricular (VV) delay timing.

The multi-centre, randomised, two-arm, double-blind, prospective trial, which is based on the company's CLEAR clinical study evaluating the use of the first-generation SonR CRT system, is expecting to start enrolling patients in the first half of 2013.

"The trial will study the safety and effectiveness of SonR in patients with advanced heart failure, and follow them for 24 months."

The company plans to enrol more than 1,000 participants across more than 100 sites worldwide.

The trial will study the safety and effectiveness of the device in patients with advanced heart failure, and follow them for 24 months.

The proportion of patients within each treatment group that respond to CRT therapy with an improvement in NYHA class or an improvement in the quality of life at 12 months is the primary effectiveness endpoint of the study.

Massachusetts General Hospital cardiac resynchronisation programme director and trial principal investigator Dr Jagmeet Singh said; "RESPOND CRT is the largest trial to date studying this system, and thus we hope to gain valuable evidence further demonstrating that the SonR system offers a significant clinical advancement and can improve heart failure symptoms for a larger number of patients."

Sorin Group CRM business unit president Stefano Di Lullo said; "Clinical results from international studies of SonR have been very positive, and we hope to extend this base of robust evidence with the RESPOND CRT trial and launch this innovative CRT system in the United States to benefit many of the 5 million Americans with heart failure."