Conditional FDA Approval For Sorin’s RESPOND CRT Trial

In short

Cardiovascular device company Sorin Group, has received conditional U.S. FDA approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure.

Background

CRT delivers timely electrical pulses to the chambers of the heart, allowing it to beat in a more coordinated, synchronized, and thereby more effective manner. Studies have shown that around one-third of patients with advanced heart failure do not effectively respond to CRT. In order to improve therapy success rate, it is important to offer each patient a tailor-made programming of the timing between electrical impulses sent to different parts of the heart (CRT settings) on a regular basis. Designed to address this specific need, the SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip™ atrial pacing lead and the PARADYM™ RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing.

RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies. It is designed to build upon Sorin’s earlier clinical experience with its first-generation device, as shown by the CLEAR clinical study which evaluated the use of the SonR CRT optimization system in 238 European patients with advanced heart failure. In that study, 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).

The primary effectiveness endpoint in the RESPOND CRT study is the proportion of patients within each treatment group that responded to CRT therapy with an improvement in NYHA class or an improvement in quality of life at 12 months and did not experience a heart failure-related adverse event or death. Patients will be followed for 24 months.

Physician comments

“The SonR system with its innovative sensor is a significant CRT engineering advancement,” said Jagmeet P. Singh, M.D., Ph.D., Director of the Cardiac Resynchronization Program at Massachusetts General Hospital in Boston and U.S. principal investigator of the RESPOND CRT trial. “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.”

Company comments

“Sorin Group has a long legacy of technology innovations, and the SonR system is an excellent example of our commitment to develop unique solutions to improve therapy effectiveness,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. “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.”

Source: Sorin Group