Cordella

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Retrieved on: 
Vendredi, janvier 5, 2024
Cordella, Food, FDA, NYHA, News, IDE, GDMT, Congestion, Patient, HF, Heart failure, PMA, Vital signs, Pharmaceutical industry

NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
  • Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home.
  • "Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year."
  • This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment .

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Retrieved on: 
Vendredi, janvier 5, 2024
Cordella, Food, FDA, NYHA, News, IDE, GDMT, Congestion, Patient, HF, Heart failure, PMA, Vital signs, Pharmaceutical industry

NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • NAPERVILLE, Ill., Jan. 5, 2024 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA).
  • Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home.
  • "Submitting this PMA application is a significant regulatory milestone and brings us one step closer to the expected commercial launch of the Cordella Sensor in the second half of this year."
  • This news follows the company's prior announcement that PROACTIVE-HF, the company's 450-patient investigational device exemption (IDE) trial, completed enrollment .

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Retrieved on: 
Lundi, octobre 9, 2023
Cordella, Incidence, Pressure, III, Mercury (element), Death, Risk, Hospital, Trial of the century, Vanderbilt University Medical Center, Safety, Congestion, Heart rate, Randomized controlled trial, Patient, HF, FDA, Heart failure, New York Heart Association Functional Classification, IDE, Clinical trial, Blood pressure, Investigator's brochure, Pulmonary hypertension, External carotid artery, Pulmonary artery, Investigational device exemption, Pharmaceutical industry, NYHA

"The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.

Key Points: 
  • "The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.
  • "The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm.
  • The PROACTIVE-HF 2 prospective, open-label randomized controlled clinical trial will enroll up to 1,500 patients in the U.S. and Europe.
  • "We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data.

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Retrieved on: 
Lundi, octobre 9, 2023
Cordella, Incidence, Pressure, III, Mercury (element), Death, Risk, Hospital, Trial of the century, Vanderbilt University Medical Center, Safety, Congestion, Heart rate, Randomized controlled trial, Patient, HF, FDA, Heart failure, New York Heart Association Functional Classification, IDE, Clinical trial, Blood pressure, Investigator's brochure, Pulmonary hypertension, External carotid artery, Pulmonary artery, Investigational device exemption, Pharmaceutical industry, NYHA

"The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.

Key Points: 
  • "The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years.
  • "The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm.
  • The PROACTIVE-HF 2 prospective, open-label randomized controlled clinical trial will enroll up to 1,500 patients in the U.S. and Europe.
  • "We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data.

Endotronix Celebrates 400th Implant of Cordella™ Pulmonary Artery Pressure Sensor for Proactive, Remote Heart Failure Management

Retrieved on: 
Vendredi, septembre 30, 2022
Hospital, Cordella, GDMT, Safety, Journal, PMA, IDE, University of California, San Francisco Fetal Treatment Center, CE marking, Compliance, Health, Pressure, Heart failure, Clinical trial, Patient, Joe Byrd (Cherokee Nation Principal Chief), Journal of Cardiac Failure, CEO, III, Geography, Guideline, Solution, Cardiology, NYHA, New York Heart Association Functional Classification, Pulmonary hypertension, University, Classification, HF, Pharmaceutical industry, Medical device, Sensor

LISLE, Ill., Sept. 30, 2022 /PRNewswire/ -- Endotronix, Inc., a privately-held digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced implantation of the 400th Cordella™ Pulmonary Artery (PA) Pressure Sensor. The milestone includes successful implants across the company's completed European trials, SIRONA First-in-Human and SIRONA 2, as well as the currently enrolling global investigational device exemption (IDE) trial, PROACTIVE-HF. Designed to unlock the power of comprehensive HF management, PROACTIVE-HF is evaluating a multisystem care delivery model that includes daily PA pressure and vital sign measurements as well as self-reported symptoms to optimize remote care.

Key Points: 
  • Dr. Klein also serves as Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at the University of California San Francisco.
  • The Cordella System and Sensor, together, provide a meaningful advancement in heart failure management that we believe will help clinicians achieve better patient engagement and outcomes."
  • Providing a more comprehensive approach to patient management, the Cordella Heart Failure System is designed to enable scalable remote heart failure management that combines patient engagement, GDMT uptitration, and diuretic optimization to improve care and prevent worsening heart failure.
  • Their solution, the CordellaHeart 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.

Endotronix Celebrates 400th Implant of Cordella™ Pulmonary Artery Pressure Sensor for Proactive, Remote Heart Failure Management

Retrieved on: 
Vendredi, septembre 30, 2022
Hospital, Cordella, GDMT, Safety, Journal, PMA, IDE, University of California, San Francisco Fetal Treatment Center, CE marking, Compliance, Health, Pressure, Heart failure, Clinical trial, Patient, Joe Byrd (Cherokee Nation Principal Chief), Journal of Cardiac Failure, CEO, III, Geography, Guideline, Solution, Cardiology, NYHA, New York Heart Association Functional Classification, Pulmonary hypertension, University, Classification, HF, Pharmaceutical industry, Medical device, Sensor

LISLE, Ill., Sept. 30, 2022 /PRNewswire/ -- Endotronix, Inc., a privately-held digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced implantation of the 400th Cordella™ Pulmonary Artery (PA) Pressure Sensor. The milestone includes successful implants across the company's completed European trials, SIRONA First-in-Human and SIRONA 2, as well as the currently enrolling global investigational device exemption (IDE) trial, PROACTIVE-HF. Designed to unlock the power of comprehensive HF management, PROACTIVE-HF is evaluating a multisystem care delivery model that includes daily PA pressure and vital sign measurements as well as self-reported symptoms to optimize remote care.

Key Points: 
  • Dr. Klein also serves as Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at the University of California San Francisco.
  • The Cordella System and Sensor, together, provide a meaningful advancement in heart failure management that we believe will help clinicians achieve better patient engagement and outcomes."
  • Providing a more comprehensive approach to patient management, the Cordella Heart Failure System is designed to enable scalable remote heart failure management that combines patient engagement, GDMT uptitration, and diuretic optimization to improve care and prevent worsening heart failure.
  • Their solution, the CordellaHeart 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.

Endotronix Announces Development Agreement for a New Expanded U.S. Headquarters in Naperville, Illinois

Retrieved on: 
Mardi, juillet 19, 2022
CEO, IDE, Patient, Geography, Safety, Cordella, Quality of life, Pulmonary artery, HFA, Cardiology, PMA, HF, Heart failure, European Society of Cardiology, FDA, Clinical trial, Workforce, HUB, Pharmaceutical industry, Medical imaging, European

LISLE, Ill., July 19, 2022 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced plans to relocate and expand their headquarters in Naperville, Illinois to support the full U.S. commercial launch of its Cordella™ Heart Failure System and Pulmonary Artery (PA) Sensor, pending pre-market approval (PMA) of the sensor by the U.S. Food & Drug Administration (FDA). The new building will significantly increase Endotronix's manufacturing and operating capacity, allowing for a 30% workforce expansion as well as continued growth opportunities in the years to come. In addition to the U.S. office, Endotronix will maintain their European office in Ireland.

Key Points: 
  • In addition to the U.S. office, Endotronix will maintain their European office in Ireland.
  • "This is an exciting time for Endotronix.
  • Headquartered in the Chicago-land area since 2013, Endotronix recently signed a lease for an 80,000+ square feet facility that will more than double their current footprint.
  • Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure.

Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study

Retrieved on: 
Mercredi, janvier 5, 2022
Consensus, New York Heart Association Functional Classification, Safety, UCSF, NYHA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cordella, HF, Patient, Cardiology, III, Heart failure, Federal, Investigational device exemption, Joe Byrd (Cherokee Nation Principal Chief), CEO, FDA, Pulmonary hypertension, News, Mortality, IDE, Geography, Technology, Guideline, Sensor, Pharmaceutical industry, Medical device

The company is currently implementing the updated PROACTIVE-HF study design at trial sites worldwide.

Key Points: 
  • 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.
  • 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.

Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study

Retrieved on: 
Mercredi, janvier 5, 2022
Consensus, New York Heart Association Functional Classification, Safety, UCSF, NYHA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cordella, HF, Patient, Cardiology, III, Heart failure, Federal, Investigational device exemption, Joe Byrd (Cherokee Nation Principal Chief), CEO, FDA, Pulmonary hypertension, News, Mortality, IDE, Geography, Technology, Guideline, Sensor, Pharmaceutical industry, Medical device

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.

Key Points: 
  • 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.
  • 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.

Endotronix Celebrates 100th Implant Of The Cordella™ Pulmonary Artery Pressure Sensor For Proactive, Remote Management Of Heart Failure

Retrieved on: 
Mardi, mars 23, 2021
Anatomy, Health sciences, Health, Heart diseases, Organ failure, Heart failure, Cardiology, Cordella, Adherence, New York Heart Association Functional Classification

The sensor provides key heart pressure readings as part of the Cordella Heart Failure System (Cordella System) to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits.

Key Points: 
  • The sensor provides key heart pressure readings as part of the Cordella Heart Failure System (Cordella System) to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits.
  • The Cordella System enables scalable remote heart failure management and aims to increase guideline directed medical therapy (GDMT) adherence and provide early detection of worsening heart failure.
  • Focusing on New York Heart Association (NYHA) Class III Heart Failure patients, both trials seek to demonstrate the benefits of comprehensive PA pressure-guided heart failure management.
  • The Cordella Sensor is under clinical investigation and is not currently available for commercial use in any geography.