Sorin Group Rhythm Management Announces CE Mark and Implant of New-Generation CRT-D Device Designed to Provide Hemodynamic Management of Heart Failure
02 September 2008
Sorin Group cardiac rhythm management announced today for the first implant in a clinical trial of its new generation PARADYM™ 8770 sonR™ cardiac resynchronization therapy defibrillator (CRT-D). This system contains a unique technology named sonR™ designed to adjust CRT delivery based on hemodynamic response as opposed to conventional CRT-D devices, that monitor the electrical activity of the heart. PARADYM™ sonR™ is the first device delivering continuous management of resynchronization therapy during patients everyday life.
Previous clinical studies have shown that up to 25% of patients, who meet the criteria for CRT and who are implanted with a CRT-D device do not benefit from the therapy. Studies suggest that, 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). Manual programming of CRT settings can be guided using echocardiography, but echo optimization is not applied for all patients because it is a time-consuming and non-standardized procedure. Moreover, patient status can change over time, due to many factors (modifications of drug regimen, life-style changes and modification of heart dimension). It is therefore crucial to re-assessand re-adjust the CRT settings on a regular basis.
Fred Hrkac, President of Sorin Group cardiac rhythm Management (CRM) business unit commented, “The SonR™ sensor is one of our most promising innovations in the treatment of heart failure because it allows to automatically re-adjust the CRT settings. Whereas conventional devices look at the heart as a ‘clock’ , new PARADYM™ sonR™ looks at the heart as a ‘pump’, measuring vibrations generated by heart contraction. Thanks to this innovative approach, we provide the medical community and their patients with a completely new system, and this is in line with our vision to become an innovative leader in hemodynamic management of heart failure.”
The new PARADYM™ device with its sonR™ functionality is designed to measure and evaluate the performance of the cardiac pump, and to adapt the CR settings to the patients’ cardiac status automatically and recurrently during patients everyday life.
A multi-centre clinical trial including 150 patients is currently being cnducted across Europe. The first sonR™ systems, the PARADYM™ sonR™ CRT-D, including the son-R™ FIX atrial lead, were implanted by Prof. Angelo Auricchio from Cardiocentro Ticino in Lugano, Switzerland, Dr Peter Paul Delnoy from Isala clinics in Zwolle, Netherlands, and Dr Neil Sulke from Eastbourne General Hospital in the United Kingdom.
