Our Performance

Sorin CRM Commitment to Quality

At Sorin CRM, we are committed to constantly delivering innovative medical devices and services that meet customer expectations and are safe, effective and compliant with quality standards and regulations. Translating innovation into clinically meaningful technology, our Cardiac Rhythm Management systems are imagined, designed and built to improve health and save lives.

Across the globe, Sorin CRM strives for the highest levels of performance and quality throughout the entire product life cycle, and for providing timely and reliable information on device performance to physicians and patients.

This May 2014 Edition of Sorin CRM’s Product Performance Report embodies our commitment to update the product performance information regularly and communicate it to physicians and patients. Our performance report is published online semi-annually at www.sorin.com. This new edition includes performance data collected through December 31, 2013 and incorporates the latest information about the company’s most recent leads and pulse generators (pacemakers, ICDs (Implantable Cardioverter Defibrillators), CRT devices (Cardiac Resynchronization Therapy), as well as the most recent updates about product advisories.

As a company, we believe that every patient is important and should be treated equally, and we aim at being fully transparent with our physicians and patients. Because the vast majority of Sorin CRM products have been marketed and used outside the United States and were released for distribution three years earlier than in the United States, Sorin CRM provides worldwide data in its Product Performance Report to ensure that patients, physicians and regulators are better informed, and sooner informed.

This report is reviewed by an independent Product Performance Monitoring Board, in compliance with the Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines(1).

We continually seek your input to help us enhance our product performance, and we encourage you to provide your comments and suggestions to your local representative. We also urge you to inform your local representative immediately about any indication of potential device malfunction with any of our products. Your contribution plays a key role in communicating accurate and vital product performance information.

We thank you for your support.

Marc Orellou

Vice President, Quality Assurance

Download the latest editions of the Product Performance Report here

(1) Carlson MD, Wilkoff BL, Maisel WH, Ellenbogen KA, Saxon LA, Prystowsky EN, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. Heart Rhythm. 2006; 3(10):1250-73.