Medtronic www.medtronic.com and Mercy www.mercy.net the fifth largest Catholic healthcare system in the U.S will work together to establish a new data sharing and analysis network to help gather clinical evidence for medical device innovation and patient access.
Traditional clinical trials can be complex, time consuming, and costly. Looking for the right the solution, Medtronic and Mercy Technology Services www.mercy.net/mercy-technology-services, seek to co-develop a new way to answer questions about medical device safety and patient outcomes through access to valuable clinical information captured during routine patient care.
In the initial phase, the data network will capture unidentified data from about 80,000 patients with heart failure to explore real world factors that can determine a patient’s response to Cardiac Resynchronization Therapy (CRT). CRT is a clinically proven heart failure treatment option for some heart failure patients designed to help the lower chambers of the heart beat together in a more synchronized pattern.
According to Dr. Joseph Drozda, Mercy’s Director of Outcomes Research, “Heart failure is a complex progressive condition. To more effectively treat patients, we need a better understanding of how the patient is responding to treatment.”
FDA’s vision is to establish a National Evaluation System for Health Technology (NEST). With a national system, FDA wants to quickly be able to generate meaningful insights from routine clinical care data.
The Medtronic and Mercy partnership was selected by the Medical Device Innovation Consortium http://mdic.org as a Demonstration Project for their use of scalable methods that generate real world evidence. This project will ultimately help shape the model for NEST to provide faster more cost effective regulatory decisions and accelerated therapy innovations.
“Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understanding how those devices perform outside of the controlled clinical trial setting”, said Dr. Rick Kuntz, Senior Vice President of Strategic Scientific Operations at Medtronic.