While there are many drugs and medical devices for treating cardiovascular diseases, including heart failure, there are still many patients worldwide with unmet needs. In the United States, heart failure contributes to over $135B in total medical costs annually, primarily attributable to inpatient costs, with up to $87K per patient in annual medical costs.1
At Astellas Rx+, our goal is to contribute to helping heart failure patients by developing cutting-edge medical technologies. DIGITIVA is one tool recently listed with the U.S. Food and Drug Administration. DIGITIVA is comprised of a medical device, a SaMD digital therapeutic, and a clinical review team. Building on the strengths of our partners, we will leverage Eko Health Inc.’s latest digital stethoscope plus cloud-based analysis software, Welldoc, Inc’s digital therapeutic capabilities, and the addition of a clinical review team with the goal of:
- Improving disease management and aiming to positively impact clinical outcomes for patients
- Providing healthcare providers with an innovative tool for supporting the management of heart failure patients
- Supporting clinical evaluation through the DIGITIVA dedicated clinical review team
- Studying whether DIGITIVA can reduce acute decompensation of heart failure through behavior change and intervention
- Reducing total cost of care to payers
Astellas is targeting initial commercial programs launching in the United States in 2024.
For additional information, the DIGITIVA™ Instructions for Use are linked here and the CORE 500™ Digital Stethoscope Instructions for Use are linked here.
Source: 1 Data on file