For most patients suffering from heart failure today, care is episodic. Medication and other treatments are only adjusted when a patient is hospitalized or sees their doctor during periodic office visits. But the digital health and medtech startup Endotronix is trying to change that by making it easier to monitor heart failure at home.
On Sunday, the Lisle, Illinois-based company shared the results from its recent clinical trial evaluating its implantable sensor technology at the European Society of Cardiology’s Heart Failure Association 2022 annual conference in Madrid, Spain. The startup’s Cordella Pulmonary Artery Pressure Sensor System, which was implanted in 70 heart failure patients at seven European sites across Ireland, Belgium and Germany, was found to be safe and effective in managing the chronic condition, the company announced Monday. There were no device failures or deaths after three months, and low rates of heart failure hospitalization, according to data shared by the company that has not yet been published.
With heart failure, the organ no longer pumps well enough to supply sufficient blood and oxygen to the body. The condition is progressive and, especially without treatment, gets worse over time. That makes it important to be able to adjust treatment to keep patients stable and out of the hospital. The Cordella sensor measures the pressure in the pulmonary artery of the heart to help health providers evaluate a patient’s condition remotely and make adjustments to medications or other treatments, said Harry Rowland, co-founder and CEO of Endotronix, in a Zoom call in advance of the Heart Failure Association conference.
The vast majority of patients hospitalized for heart failure have elevated pressure in the pulmonary artery, Rowland said. High pressure in the pulmonary artery is the leading indicator of worsening heart failure, he said.
“So if you could see those pressures rising when they’re at home a couple of weeks in advance of when they need that emergency help, physicians can intervene—they can change the medications that a patient is on,” Rowland said. “The patients can get their heart stabilized when they’re at home without the need to (be hospitalized).”
The Cordella sensor is placed inside the patient’s pulmonary artery using a catheter that is inserted either through the jugular vein in neck or the femoral vein in the leg.
“It’s a short procedure, generally an hour or less—the patient gets the sensor implanted, and they can go home the same day,” Rowland said.
Then every day thereafter, in the morning typically, they’ll wake up and place a handheld device on their chest that energizes the implanted sensor and measures the pressure inside the heart, he explained. Those pressure readings are sent remotely to the patient’s health provider.
“The sensor and system helps me to individualize therapy for my patients,” said Dr. Wilfried Mullens, the principle investigator for the clinical trial, and a cardiologist at Hospital Oost-Limburg in Genk and University Hasselt, Belgium, in an email. “As there’s no ‘one-size-fits-all’ for HF patients, this is very important.”
He noted that the study demonstrated using the device not only reduces heart failure hospitalizations and deaths, but improved patient’s quality of life. The study found that about two-thirds of patients saw their heart failure classification improved, which is based on a patient’s functional level.
The device is currently being studied in patients with class 3 heart failure (based on the New York Heart Association functional classification system, out of four total classes); these patients run out of breath with minimal activity, like walking at a normal pace. But heart failure patients can move between classes; and those with class 2 heart failure are generally fine walking at a normal pace, and might only run out of breath if they pushed up the pace.
The study found 41 patients who had class 3 heart failure, met the criteria for class 2 heart failure after three months; and five patients met the criteria for class 1 heart failure, when a person typically has no symptoms, and there’s no limitation on activity.
“Patients do not mind doing the measurements several times a week as the system is very easy to use and does not take much time to handle,” Mullens said. “They also have a sense of security as our HF team will react to the data provided.”
Endotronix still has work to do before its Cordella sensor is approved in Europe or the U.S. The company expects to complete enrollment for a 450-patient trial later this year and conduct the trial next year with a goal of winning FDA approval in the first half of 2024, Rowland said.
It also has competition. Namely, Abbott’s FDA-approved CardioMEMS device uses an implantable sensor to measure pressure inside the heart in patients with class 3 heart failure. For patients with an implanted CardioMEMS sensor, readings are taken by lying on a “smart pillow,” and then sent remotely to clinicians.
Rowland contends his company’s system is more user-friendly, as patients can quickly take readings in a seated position using its handheld device. In the recent trial, 93% took daily readings for six months. He said that high level of patient compliance will ultimately mean doctors have more information to better manage heart failure, so they can help patients stay out of the hospital and improve their quality of life.