Subjects: TRI, FDA
Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study
Amended study design provides immediate access and clinical benefits for all patients and becomes the first global IDE study for PA pressure-guided heart failure management
LISLE, Ill., Jan. 5, 2022 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company's PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor1, shifting the design from a randomized control study to a single-arm study. Following the 2021 update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment and the recently presented GUIDE-HF data, the FDA's decision underscores the clinical benefits of PA pressure-guided HF management for New York Heart Association (NYHA) class III heart failure patients2,3. The new PROACTIVE-HF trial design ensures the over 100 previously enrolled patients have immediate access to the proven clinical benefits of PA pressure-guided therapy and expands the study to include clinical sites across Europe, as well as the U.S. The company is currently implementing the updated PROACTIVE-HF study design at trial sites worldwide.
"The FDA's decision to approve the amended study design further validates what we are seeing in clinical practice. PA pressure-guided heart failure management is quickly becoming standard of care for NYHA class III patients based on the growing body of evidence supporting this approach," commented Dr. Liviu Klein, Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at UCSF and National Principal Investigator of the PROACTIVE-HF trial. "Understanding changes in PA pressure data is key to properly implementing guideline directed medical therapy and keeping these patients out of the hospital. The Cordella HF System and Sensor offers the next gen technology in PA pressure sensing and will play a critical part in how heart failure patients are managed moving forward."
The single-arm study design maintains similar safety and efficacy endpoints as the original study design, with the primary efficacy endpoint designed to demonstrate low rates of all-cause mortality and HF hospitalizations in the high-risk NYHA class III patient cohort. Under the updated study design, the PROACTIVE-HF trial will enroll over 400 NYHA class III patients at more than 100 sites worldwide. The trial is expected to complete enrollment in the second half of this year.
"The FDA's decision is great news for our PROACTIVE-HF study patients ? they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Furthermore, it is an important acknowledgement for the therapeutic category and the benefits that PA pressure-guided heart failure management enables," stated Harry Rowland, CEO of Endotronix. "Our team and clinical partners have been energized by the announcement and it obviously has a significant impact on our ability to bring the Cordella Sensor to market sooner in the U.S. and Europe."
About Endotronix
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordellatm Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. Learn more at www.endotronix.com.
The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella PA Sensor is currently under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial) and is not currently available for commercial use in any geography.
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.
- CAUTION: Investigational device. Limited by Federal law to investigational use.
- Maddox TM, Januzzi JL et al. 2021 J Am Coll Cardiol. 2021 Feb, 77 (6) 772-810.
- Lindenfeld J, Zile MR, et al. Lancet. 2021 Sept 11; 398 (10304):991-1001.
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