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Performance

 

At the LivaNOva Cardiac Rhythm Management business unit, (formerly 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 CRM systems are imagined, designed and built to improve health and save lives.

Across the globe, we strive 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 2016 Edition of LivaNova's 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.livanova.sorin.com. This new edition includes performance data collected through December 31, 2015 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 for full transparency with our physicians and patients. Because our products are globally marketed, with the majority of patients outside the United States, the LivaNova CRM division provides worldwide data in its Product Performance Report to ensure that patients, physicians and regulators are better 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 Guidelines1.

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 problem with our devices. Your contributions play a key role in communicating accurate and vital product performance information.

We thank you for your support.

 
Bryan Olin

Vice President, Quality Assurance
Cardiac Rhythm Management

 

 

1Carlson 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.

 

 

CRM Product Performance Reports

To view and download a report, see the list below:

 

  • May 2016 Product Performance Report download 1.12 MB application/pdf

  • November 2015 Product Performance Report download 3.72 MB application/pdf

  • May 2015 Product Performance Report download 4.31 MB application/pdf

  • November 2014 Product Performance Report download 4.16 MB application/pdf

  • May 2014 Product Performance Report download 4.76 MB application/pdf

  • May 2013 Product Performance Report download 2.07 MB application/pdf

  • November 2012 Product Performance Report download 1.74 MB application/pdf

  • May 2012 Product Performance Report download 1.43 MB application/pdf

  • November 2011 Product Performance Report download 1.42 MB application/pdf

  • May 2011 Product Performance Report download 1.44 MB application/pdf

  • November 2010 Product Performance Report download 1.19 MB application/pdf

  • May 2010 Product Performance Report download 1.16 MB application/pdf

  • November 2009 Product Performance Report download 1.09 MB application/pdf

  • May 2009 Product Performance Report download 934.16 kB application/pdf

  • November 2008 Product Performance Report download 1.25 MB application/pdf

  • May 2008 Product Performance Report download 1.27 MB application/pdf

  • November 2007 Product Performance Report download 1.69 MB application/pdf

  • May 2007 Product Performance Report download 3.07 MB application/pdf

  • November 2006 Product Performance Report download 1.46 MB application/pdf

  • May 2006 Product Performance Report download 1.16 MB application/pdf

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