Sorin and Cyberonics have merged and are now LivaNova.
Information found here may no longer be correct or up-to-date: please visit www.livanova.com
for the most current information.
Your continued use of our website constitutes understanding and acceptance of these changes.
At the LivaNova Cardiac Rhythm Management (CRM) franchise, 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, LivNova CRM strives to ensure the highest levels of performance and quality throughout the entire product life cycle, and to provide timely and reliable information on device performance to physicians and patients.
This November 2017 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 June 30 2017 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 Guidelines1,2.
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.
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.
2.Maisel WH, Hauser RG, Hammill SC, Hauser RG, Ellenbogen KA, Epstein AE, Hayes DL, et al. Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines Developed in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm 2009; 6(6): 869-885