Endotronix is carving out a spot to be a dominant player in the heart failure treatment market. The Lisle, IL-based firm said it has enrolled the first patient in a trial to evaluate the safety and efficacy of the Cordella Pulmonary Artery Pressure Sensor System.
Data from the SIRONA II trial will support a CE mark submission. The study will enroll up to 60 patients in up to eight sites in Europe.
“We’re looking for product safety,” Katrin Leadley, MD, CMO of Endotronix,told MD+DI. “We have an endpoint at 30 days for overall safety associated with any complications of this device. We also have an endpoint after 90 days to evaluate the accuracy of the sensor.”
The Cordella Sensor is implantable and streamlines HF care management along with providing early detection of worsening heart failure. Endotronix has also developed the Cordella Heart Failure System, a remote patient management software solution.
Together the Cordella System and Sensor aim to proactively provide healthcare providers with the information they need to improve patient care between office visits while supporting reimbursement for care delivery activities. The system enables remote titration of medication and streamlines patient management to help keep patients out of the hospital.
Leadley said the SIRONA II trial builds on the success of the company’s First-in-Human trial and expands its experience with the Cordella Sensor as it progresses toward receiving CE mark.
Endotronix noted the sensor could gain CE mark for the technology sometime next year. Plans call for the company to also seek out a nod from FDA for the Cordella Pulmonary Artery Pressure Sensor.
“We are in very close communication with FDA currently,” she said. “And the anticipated start of the IDE trial would be in 3Q19 or 4Q19.
When and if the Cordella Pulmonary Artery Pressure Sensor System gains approval, the sensor would go up against Abbott Laboratories CardioMEMS HF System. The Abbott Park, IL-based company inherited the CardioMEMS technology when it acquired St. Jude Medical in 2016 for $25 billion.
However, St. Jude didn’t develop the HF system. It acquired Atlanta-based CardioMEMS for $455 million to gain access to the technology.
“From a sensor and technology perspective we are similar [to CardioMEMS] of course,” she said. “However, [Cordella] has different advantages. We have a handheld reader, so the patients don’t have to lay down. For HF patients this is a big deal because they don’t like laying down because of shortness of breath. Also, a pretty big differentiating factor is patients can use the Cordella Heart Failure System along with the pressure sensor.”
She added, “The physician is seeing – in addition to pulmonary artery pressure, the systemic blood pressure; and heart rate. The physician has a more comprehensive opportunity to treat the HF …”
News of the trial comes nearly a year after Endotronix announced raising $45 million in a series D round to support commercialization efforts surrounding its technology. The company gained significant attention in January, when Canaccord Genuity's Jason Mills identified the firm as one of 16 disruptive medtech companies in the private sector.