Clamart, France - On June 01, 2018, MicroPort®CRM, a business unit of MicroPort Scientific Corporation ("MicroPort®"), announced the approval by the Japanese Pharmaceutical and Medical Devices Agency ("PMDA") of PLATINIUM™ 4LV SonR CRT-D cardiac resynchronization device and the associated SonRtip™ lead featuring the innovative SonR technology.
The SonR system uses an innovative contractility micro-sensor embedded in the SonRtip lead to assess the patient's left ventricular contractility and optimize the Cardiac Resynchronization Therapy ("CRT") response in heart failure patients. Based on the patient's heart activity and needs, the algorithm automatically optimizes atrioventricular ("AV") delay and interventricular ("VV") delay settings – with the goal of improving the cardiac performance. Optimization is performed weekly at rest and during exercise which allows the therapy to be continuously adapted to the individual needs of each patient1.
The safety and clinical effectiveness of MicroPort®'s proprietary SonR Cardiac Resynchronization system were evaluated in RESPOND- CRT study, a multi-center, randomized, two-arm, double-blinded, prospective trial enrolling more than 1,000 patients with advanced heart failure. Automatic optimization with SonR was compared to manual echocardiography guided optimization.
The one-year data showed that the study met its primary safety and efficacy end points and demonstrated that SonR was associated with a 35% risk reduction in heart failure hospitalization2.
Longer term results, after a complete 18 months patient follow-up, confirmed the significant risk reduction in heart failure hospitalization. In addition, the study showed that the clinical outcomes were especially in favor of SonR in subgroups of patients less prone to respond to CRT. In patients with a renal dysfunction and a history of atrial fibrillation, SonR was associated with a 45% and 52% risk reduction in all-cause death or cardiovascular hospitalization respectively, and with a 38% risk reduction in all-cause death or HF hospitalization in patients with left bundle branch block and narrow QRS3.
"We've seen excellent long-term clinical results from the RESPOND CRT study on SonR optimization system." said Benoît Clinchamps, MicroPort®, President of the CRM Business Unit. "Embracing MicroPort®'s commitment to advancing medical therapies to treat patients around the globe, we're pleased to bring this exclusive innovative technology for the benefit of Japanese patients who suffer from advanced heart failure."
About CRT
Cardiac Resynchronization Therapy ("CRT") is a therapy that delivers timely electrical pulses to the chambers of the heart. This allows the heart to beat in a more coordinated and synchronized manner, improving the heart's pumping efficiency and blood flow. Studies have shown, however, that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. A major cause of poor CRT response is inappropriate AV and VV timing.
About the RESPOND-CRT Trial
The RESPOND-CRT study is a prospective, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of the SonR system. The trial enrolled 1,039 patients at 125 sites in Europe, US and Australia who were implanted with a CRT-D device. Patients were randomized 2:1 to receive AV or VV optimization either with SonR or echocardiography. The primary analyses were performed at 12 months, secondary analysis were performed at 18 months.
The RESPOND-CRT trial is an Investigation Device Exemption (IDE) study approved by the Food and Drug Administration ("FDA"). The study met all of its primary safety and efficacy end points. The SonRtip lead was proven to be safe, with only 1% of patients reporting lead dislodgement and 0.1% of patients reporting lead fracture. Optimization with SonR was proven to be as effective as echo-guided optimization based on responder rates. Patients were defined as responders at 12 months based on a hierarchical set of criteria as follows: alive, free from heart failure events, with an improved NYHA functional class or quality of life. Responder rates were 75% in the SonR arm and 70.4% in the Echo arm with [P <0.0001 non-inferiority]. The design of the trial has been published in the American Heart Journal, 2014.
About SonR contractility sensor
The SonR optimization system consists of the SonR micro-accelerometer sensor embedded in the SonRtip™atrial pacing lead and of the SonR optimization algorithm featured in the PLATINIUM™SonR CRT-D device.
Result of a 10-year clinical science program, the SonR sensor is designed to uniquely measure patient's cardiac muscle vibrations generated by the myocardium during cardiac contractions. SonR measurements correspond to LVdP/dtmax, the gold standard for assessing left ventricular contractility, a key indicator of cardiac performance. These real-time measurements are transmitted to the CRT-D device which uses them to determine the best settings for the patient. Every week, the system automatically optimizes to adapt to the patient's changing condition. SonR is the only CRT contractility sensor-based optimization system that is designed to automatically optimize patients every week and, importantly, while the patient is active, providing real-life optimization.
SonR technology is available exclusively in MicroPort® CRM Cardiac Resynchronization devices.
References
1. Brugada J., Brachmann J., Delnoy P.P., et al. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND-CRT) trial. Am Heart J 2014;167:429-36.
2. Brugada J., Delnoy P.P., Brachmann J. et al. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7; 38(10): 730-738.
3. Singh J., Aydin A., Murgatroyd F. et al. Automatic contractility sonsor-guided optimization is associated with improved outcomes in CRT subgroups at high risk of non-response. Heart Rhythm 2017; 14(Suppl 5.): C-AB36-02
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