July 24, 2024 04:15 PM Eastern Daylight Time IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term […]
Tag: Endotronix
Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial
NAPERVILLE, Ill., Oct. 9, 2023 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, […]
Endotronix Extends Positive Outcomes with 12-month Data Release from the SIRONA 2 Trial for Remote Heart Failure Management Using the Cordella Pulmonary Artery Sensor
The study met secondary study endpoints and long-term sensor use was associated with significant improvements in patient quality-of-life metrics and low event rates for heart failure hospitalization and death LISLE, Ill., May 22, 2023 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology […]
Endotronix Announces Enrollment Completion of PROACTIVE-HF Pivotal Trial
Data to support regulatory submission and accelerate U.S. market access for the Cordella™ Pulmonary Artery (PA) Sensor Cordella™ is the first and only patient management platform to provide both critical PA pressure data, using an implanted sensor, and noninvasive vitals (blood pressure, […]
Endotronix Celebrates 400th Implant of Cordella™ Pulmonary Artery Pressure Sensor for Proactive, Remote Heart Failure Management
Company also announces publication of the PROACTIVE-HF trial design rationale, the first global IDE trial for PA pressure-guided heart failure management, in the Journal of Cardiac Failure LISLE, Ill., Sept. 30, 2022 /PRNewswire/ — Endotronix, Inc., a privately-held digital health and medical technology company dedicated […]
Endotronix Announces Development Agreement for a New Expanded U.S. Headquarters in Naperville, Illinois
Company is constructing a new commercial manufacturing facility and anticipates expanding its workforce to support the launch of its comprehensive patient management platform for heart failure LISLE, Ill., July 19, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to […]
Endotronix Announces Positive Data from SIRONA 2 in Late-Breaking Clinical Trial Session
Study met all primary safety and efficacy endpoints for the Cordella™ PA Pressure Sensor System for the treatment of NYHA class III heart failure patients LISLE, Ill., May 23, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing […]
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 […]
Endotronix Celebrates 100th Implant Of The Cordella™ Pulmonary Artery Pressure Sensor For Proactive, Remote Management Of Heart Failure
Milestone achieved as company prepares for next stage of commercial growth and expansion LISLE, Ill., March 23, 2021 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global […]
Endotronix Appoints Industry Veteran Dan Dearen to Board of Directors
Expands company’s financial expertise during time of growth in advance of commercial launch LISLE, Ill., March 2, 2021 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment […]