Edwards Lifesciences Corp. (EW) announced an update on their ongoing clinical study.
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Study Overview
The “SMART TRENDS Study,” officially titled “Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery,” evaluates whether Edwards Lifesciences’ monitoring software can help doctors better manage blood pressure during moderate- to high‑risk noncardiac surgery and potentially limit kidney injury. This completed feasibility study matters for investors because it tests the clinical value of Edwards’ next‑generation hemodynamic tools, which support the company’s premium monitoring ecosystem.
Intervention/Treatment
The study tests two device options. The first is the Acumen HPI Smart Alerts and Smart Trends software, used with the Acumen IQ sensor, designed to warn clinicians when a patient is trending toward low blood pressure. The second adds the full HemoSphere advanced monitoring platform with Acumen HPI software, plus the Acumen IQ sensor and IQ cuff, aiming to give continuous, less invasive blood‑pressure tracking and early warning of trouble during surgery.
Study Design
This is an interventional, multicenter feasibility study using a non‑randomized, sequential design that compares outcomes to historical controls. All participants receive one of the monitoring approaches; there is no blinded or placebo group, and neither clinicians nor patients are masked. The main goal is practical: to see if the technology can be used smoothly in routine surgery and whether it supports better blood‑pressure management and reduced kidney complications, rather than to test a drug or new surgical procedure.
Study Timeline
The study was first submitted in July 2023, signaling when Edwards formally moved this program into the clinical‑evaluation phase. The trial has since reached overall “Completed” status, meaning enrollment and follow‑up are finished, though results have not yet been posted. The listing was most recently updated on December 19, 2025, showing that Edwards is actively maintaining the record as it moves towards data reporting and potential integration of findings into product messaging and commercial strategy.
Market Implications
For Edwards Lifesciences (EW), positive findings from the SMART TRENDS study could support wider adoption of its HemoSphere and Acumen HPI platform, reinforcing its position in advanced monitoring within the peri‑operative and critical‑care markets. If data show better kidney outcomes or smoother blood‑pressure control, hospitals may see stronger value in upgrading to these premium systems, supporting recurring revenue from sensors and cuffs. Investor sentiment could improve on signs that Edwards can deepen its technology moat beyond valves and into data‑driven monitoring, especially as competitors like Baxter, GE HealthCare, and Philips push their own smart‑monitoring solutions. Until detailed results are released, the update mainly signals pipeline progress rather than a near‑term earnings catalyst, but it enhances the narrative that Edwards is building a broader, software‑enabled surgical‑care franchise. The study is completed and recently updated, with further details available on the ClinicalTrials.gov portal.
