Endotronix claims FDA approval for heart failure sensor implant

Endotronix claims FDA approval for heart failure sensor implant

Endotronix has secured an FDA approval for its early warning sensor implant to remotely track patients with serious and potentially worsening heart failure.

The minimally invasive Cordella system keeps tabs on the pressure within the pulmonary artery. As it becomes more difficult for the blood to pass through on its way to the lungs, the heart has to work harder, which puts more strain on the cardiac muscle.

With a handheld scanner that connects with the implanted device, patients can take their own readings at home alongside daily blood pressure measurements from an arm cuff.

“Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” said Liviu Klein, principal investigator of the Cordella system’s pivotal trial and section chief at the University of California San Francisco.

This past March, Endotronix reported six-month data from its clinical study, dubbed PROACTIVE-HF, which showed lower rates of heart failure-related hospitalizations and all-cause mortality, as well as gains in patient-reported outcomes and quality-of-life measures. Klein attributed those improvements to the sensor data helping to drive more optimized and timely dosings of key medications.

“In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes,” he said in a statement.

Endotronix, a former Fierce Medtech Fierce 15 winner, said it plans to launch Cordella in the U.S. later this year. It has also submitted the system for review in Europe and expects a CE mark decision in 2025.

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