This section highlights FDA-related milestones and regulatory updates for drugs developed by Edwards Lifesciences (EW).
Over the past two years, Edwards Lifesciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PROACTIVE-HF and SAPIEN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PROACTIVE-HF - FDA Regulatory Timeline and Events
PROACTIVE-HF is a drug developed by Edwards Lifesciences for the following indication: For the Cordella Pulmonary Artery (PA) Sensor System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PROACTIVE-HF
- Announced Date:
- September 28, 2024
- Indication:
- For the Cordella Pulmonary Artery (PA) Sensor System.
Announcement
Endotronix, an Edwards Lifesciences company announced the one-year clinical results from PROACTIVE-HF, evaluating outcomes for the Cordella Pulmonary Artery (PA) Sensor System.
AI Summary
Endotronix, an Edwards Lifesciences company, shared one-year clinical results from the PROACTIVE-HF trial at the HFSA Annual Scientific Meeting. The study evaluated the Cordella Pulmonary Artery (PA) Sensor System, which directly measures PA pressure—a key indicator of congestion in heart failure patients. Involving 456 patients, the trial demonstrated a significant reduction in both heart failure hospitalizations and all-cause mortality. Specifically, the event rate dropped from 70 to 36 per 100 patients, which is a 49% reduction. Additionally, improvements were seen in quality of life measures, including a rise in the Kansas City Cardiomyopathy Questionnaire score, better performance in the 6-minute walk test, an improved New York Heart Association classification, and a reduction in NT-proBNP levels. The results support the use of PA pressure-guided therapy to adjust treatment and engage patients, ultimately improving heart function and outcomes.
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SAPIEN - FDA Regulatory Timeline and Events
SAPIEN is a drug developed by Edwards Lifesciences for the following indication: For Ultra transcatheter heart valve.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAPIEN
- Announced Date:
- May 1, 2025
- Indication:
- For Ultra transcatheter heart valve
Announcement
Edwards Lifesciences announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.
AI Summary
Edwards Lifesciences announced that the FDA has approved its transcatheter aortic valve replacement (TAVR) therapy, using the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms. This marks the first time the FDA has approved a TAVR treatment for asymptomatic patients. The decision was based on promising data from the groundbreaking EARLY TAVR trial, which compared early TAVR intervention with the traditional “watchful waiting” approach. The trial demonstrated that patients receiving the SAPIEN 3 treatment experienced better outcomes than those monitored under current clinical guidelines. Early intervention can reduce the high risks associated with the sudden onset of symptoms and the rapid progression of severe AS, offering new hope for improved patient care and outcomes.
Read Announcement- Drug:
- SAPIEN
- Announced Date:
- November 25, 2024
- Indication:
- For Ultra transcatheter heart valve
Announcement
Edwards Lifesciences announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve.
AI Summary
Edwards Lifesciences recently announced one-year data showing the excellent performance of its SAPIEN 3 Ultra RESILIA valve. Data from over 9,000 patients revealed very low mortality and reintervention rates, along with larger effective orifice areas and lower echo-derived gradients across all valve sizes. Notably, 84.4% of patients experienced no paravalvular leak, underscoring the valve’s improved performance compared to earlier models.
The results further showed significant improvement in patients’ quality of life, with an average 31-point increase in their Kansas City Cardiomyopathy Questionnaire scores and an average hospital stay of just one day. These findings support the valve’s effectiveness, offering faster recovery times and better clinical outcomes, which is particularly important for patients with lower surgical risks and longer life expectancies.
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