Mortara Instrument Announces ECG Warehouse Contract Awards With US FDA
MILWAUKEE, Sept. 30 /PRNewswire/ — Today Mortara Instrument announced the award of two contracts from the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). The first award is a multi-year contract for continued maintenance of the FDA ECG Warehouse, and the second award supports the expansion of the ECG Warehouse to incorporate continuous 12-lead ECG recordings.
Mortara has a long-standing relationship with the FDA, providing ECG algorithm tools and data warehousing solutions to support the Agency’s regulatory review of cardiac safety data. Since 2006, the FDA has been using the ECG Warehouse and toolset to review ECG studies submitted to them. To facilitate the FDA review process, the ECG Warehouse incorporates Mortara’s VERITAS(TM) ECG algorithms which analyze and quantitatively evaluate the submitted ECG data. Today the ECG Warehouse contains over 4 million ECGs from more than 420 ECG studies, all of which have been automatically analyzed by the VERITAS algorithms.
Under the ECG Warehouse maintenance contract, Mortara will continue to support Sponsor and ECG Central Laboratory upload of ECG studies, provide support to FDA personnel, and provide on-going basic development enhancements to the ECG Warehouse.
The ECG data submitted from cardiac safety studies are often extracted from continuous ECG recordings done with 12-lead Holter monitors or 12-lead telemetry at protocol-specified time points. Under the contract to supply an ECG Warehouse for continuous 12-Lead Holter recordings, Mortara will be tasked with providing the Agency the means to review the full underlying ECG data set as well as the extracted ECGs. The expanded warehouse tools will include provision for web-based upload, navigation of continuous data, arrhythmia identification, and waveform morphology comparison.
The intent is to support review of continuous recordings that are typically the underlying data source for the discrete ECGs that are currently being submitted to the FDA ECG Warehouse today. This work will be the first step in positioning the FDA to request the upload of continuous recordings as part of the cardiac safety regulatory review process.
Mark Mentzer, Vice President of Clinical Research for Mortara Instrument commented, “Mortara is pleased to utilize its expertise in the field of continuous 12-lead ECG acquisition and analysis to provide the Agency with an expanded version of the ECG Warehouse. Mortara is the leading provider of 12-lead continuous data technology, and has proven experience in providing tools for the regulatory review of ECG data. This award is validation that we are making a difference in cardiac safety evaluation and that our expertise will help to shape the future.”
About Mortara Instrument, Inc.
Mortara Instrument, Inc., based in Milwaukee, WI, is distinguished in the field of non-invasive diagnostic cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems and data warehousing solutions, and cardiology monitoring systems. Mortara Instrument manufactures and distributes its ECG devices and related technology worldwide. The company’s web site is www.mortara.com.
SOURCE Mortara Instrument