Endotronix Inc. Archives - Medical Design Sourcing

Endotronix has positive pulmonary artery sensor data

The Cordella system. [Image courtesy of Endotronix]Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor.

Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes.

The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of congestion. It met primary safety and efficacy endpoints and demonstrated a markedly low rate of HF hospitalizations. Endotronix also reported a clinically significant improvement in patient quality of life, increased physical activity and improvement in the NYHA functional class.

Positive results from PROACTIVE-HF follow the company’s premarket approval (PMA) application to the FDA for Cordella in January. Dr. Liviu Klein presented the results at the Technology and Heart Failure Therapeutics (THT) Conf…

Endotronix submits pulmonary artery sensor for FDA premarket approval

The Cordella system. [Image courtesy of Endotronix]Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system.

Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes.

The Cordella system delivers proactive PA pressure data and non-invasive vital health data for at-home HF management. Its user-friendly devices securely transmit daily health information to the managing clinician as well. This supports the optimal dosing of guideline-directed medical therapy, reducing congestion and engaging patients.

In April, Endotronix completed enrollment in its Proactive-HF pivotal study supporting its application for FDA premarket approval. Endotronix said that Proactive-HF enrolled more than 450 patients across the U.S., Ireland and Belgium. The study’s primary endpoints include mor…

Endotronix wins FDA IDE for Cordella pressure-guided therapy trial

The Cordella system. [Image courtesy of Endotronix]Endotronix announced today that the FDA granted it investigational device exemption (IDE) to conduct a study for its Cordella sensor.

The study evaluates the use of Cordella in pulmonary artery (PA) pressure-guided therapy. PROACTIVE-HF 2, a prospective, dual-arm trial, aims to expand access for heart failure patients. Endotronix seeks to support efficient and scalable remote patient management with a clinician-directed self-management strategy.

According to a news release, the company expects to enroll up to 1,500 patients in the U.S. and Europe. It anticipates the first patient enrollment later this year.

PROACTIVE-HF 2’s randomized arm assesses the safety and efficacy of PA pressure-guided therapy using Cordella. That arm evaluates NYHA Class II patients at risk for congestion. In both cohorts, patients and clinicians can access daily trended telehealth data. The treatment cohort can also access da…

Endotronix expands U.S. headquarters in Illinois

Endotronix today announced plans to relocate and expand its headquarters in Naperville, Illinois to support a commercial launch of its heart failure treatment devices.

The company’s new building will significantly increase its manufacturing and operating capacity to grow its workforce by 30%. The new location also allows for continued expansion for its Cordella heart failure system and pulmonary artery sensor, which is pending FDA pre-market approval.

The 80,000 sq. foot facility more than doubles its current footprint. It is undergoing custom enhancements to include a state-of-the-art cleanroom, manufacturing, quality and administrative space. Endotronix expects the first phase of construction to be completed in early 2023 and will include a hybrid workspace designed to accommodate a flexible workforce.

“This is an exciting time for Endotronix. As we approach full enrollment in our Proactive-HF clinical trial, we are looking ahead toward sca…