Sorin won an Investigational Device Exemption (IDE) from the FDA and a go-ahead to begin a trial of the SonR cardiac resynchronization therapy technology inside the PARADYM RF SonR CRT-D implant.
The device uses a special SonRtip atrial pacing lead with a built-in hemodynamic sensor to monitor the heart. The defibrillator is then adjusted at the clinic on a weekly basis to perfect the timing of the electric signals.
While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.
The RESPOND study is designed to build upon Sorin’s earlier clinical experience with its first-generation SonR device, as shown by the CLEAR clinical study described in the September 2012 issue of the peer-reviewed journal Europace. The published results from the CLEAR clinical study which evaluated the use of the first generation SonR CRT optimization system in 238 European patients with advanced heart failure, showed that at 12 months 76 percent of patients receiving SonR CRT optimization were classified as improved, compared with 62 percent in the group of patients with standard CRT programming (p=0.0285).
Product page: Paradym RF SonR CRT-D…