ARTICLE SUMMARY:
The FDA recently approved a single-arm pivotal trial design for Cordella, the implantable heart failure sensor of Endotronix, a validation of the clinical benefit of the new product category and a boon to the start-up, which can now complete its clinical trial sooner and at a lower cost.
Endotronix Inc. was founded in 2007 to develop a new pulmonary artery pressure (PAP) sensor for heart failure, joining a product category created by two major strategics. That same year, Medtronic plc became the first to go to the FDA (without success) with its Chronicle implantable hemodynamic monitor, and in 2014 Abbott Laboratories Inc. gained approval for its CardioMEMS HF monitor. Coming into the market later than these two strategic powerhouses Endotronix plans to compete on the basis of an improved sensor, a patient-friendly interface, and a digital health platform designed not only for the engagement of patients and clinicians but also for the collection of rich data. “We have a next-generation pulmonary artery pressure sensor system, and we focused on making it a better user experience for each end user—for the implanting cardiologist, the patient at home, and the clinical staff that uses the information to make medication change decisions,” says Harry Rowland, PhD, co-founder and CEO of Endotronix. But perhaps the small company’s greatest competitive advantage is its timing.
