ANN ARBOR, MICH. / JUNE 30, 2020 – The Extracorporeal Life Support Organization and ArborMetrix today announced the launch of ELSO Evidence Explorer, a powerful new tool that enables ECMO manufacturers to understand how their devices and technologies perform in real-world clinical settings.
“Clinicians, industry, and regulators value real-world data and evidence to improve product development, develop new indications, and promote patient safety,” said Christine Stead, Chief Executive Officer, ELSO. “The ELSO Evidence Explorer from ArborMetrix provides a novel platform to rapidly and easily explore the real-world evidence from the largest collection of multi-national ECMO centers in the world.”
The use of real-world evidence is increasingly recognized by regulatory agencies worldwide. It aids in developing appropriate study designs for new indications for existing products, as well as for introduction of new products. This is especially important for ECMO, which until recently has been largely performed off-label. Given the complexity of care and the high rate of mortality and complications, ECMO care also presents limitations for traditional clinical trials, which can be mitigated through real-world registry data.
Making real-world clinical data available to manufacturers helps address these challenges. ELSO Evidence Explorer takes real-time post-marketing data from more than 700 centers worldwide and transforms it to help manufacturers know how clinicians are actually using their devices, what the average patient looks like, and how their device truly performs in the real-world.
“ELSO, as the worldwide leader in extracorporeal life support advocacy, sees tremendous value in the ELSO Evidence Explorer to improve ECMO care,” said Matthew Paden, M.D., President-Elect, ELSO. “Complications can occur during ECMO, and patients who have a complication are more likely to not survive. We are providing a needed tool that can aid our centers in choosing the individual medical devices that are needed to provide ECMO safely.”
ELSO is the first to leverage ArborMetrix Evidence Explorer. “Our vision for Evidence Explorer is simple,” said Spencer Heaton, M.D., M.B.A., Chief Medical and Commercial Officer, ArborMetrix. “We are making possible the sharing of clinically-rich, specialty and condition-specific data in a way that is safe and secure. Our technology platform can be rapidly adapted and deployed to answer questions as they emerge. This ensures all stakeholders have the evidence and answers needed to develop safer clinical practice and devices for the next generation. It is a win, win, win for physicians, industry partners, and, most importantly, patients.”
ELSO Evidence Explorer is available via annual subscription to ECMO manufacturers who are ELSO corporate members.
To learn more, visit elso-explorer.arbormetrix.com.
The Extracorporeal Life Support Organization (ELSO) is an international non-profit consortium of healthcare institutions who are dedicated to the development and evaluation of novel therapies for support of failing organ systems.
ELSO’s global registry is the single source of truth that drives life-saving research for ECMO and other innovative therapies. The ELSO community, which includes more than 700 participating centers across 66 countries worldwide, uses the registry to support clinical research, individual ELSO center quality assessment, and regulatory needs for ECMO. The registry includes data for more than 100,000 ECMO runs.
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