For most heart failure patients today, care is episodic. Medications and other treatments are only adjusted when a patient is hospitalized or sees their doctor during periodic office visits. But digital health and medtech startup Endotronix is trying to change that by making it easier to track heart failure at home.
On Sunday, the Lisle, Illinois-based company shared the results of its recent clinical trial evaluating its implantable sensor technology at the European Cardiovascular Association’s 2022 annual conference for heart failure in Madrid, Spain. Spain. The start-up’s Cordella pulmonary artery pressure sensor system, which was implanted in 70 heart failure patients at seven European sites in Ireland, Belgium and Germany, has been shown to be safe and effective in managing heart failure. chronic illness, the company announced on Monday. There were no device failures or deaths after three months, and low rates of heart failure hospitalizations, according to data shared by the company that has yet to be released.
In heart failure, the organ no longer pumps well enough to supply enough blood and oxygen to the body. The condition is progressive and, especially without treatment, gets worse over time. It is therefore important to be able to adjust treatment to keep patients stable and out of hospital. The Cordella sensor measures pressure in the heart’s pulmonary artery to help healthcare providers assess a patient’s condition remotely and adjust medications or other treatments, said Harry Rowland, co-founder and CEO of ‘Endotronix, in a Zoom call ahead of the Heart Failure Association conference.
The vast majority of patients hospitalized for heart failure have high pressure in the pulmonary artery, Rowland said. High pressure in the pulmonary artery is the main indicator of worsening heart failure, he said.
“So if you could see those pressures increasing when they’re home a few weeks before they need that emergency help, the doctors can step in – they can change the medications a patient is taking,” Rowland said. “Patients can stabilize their heart when they’re at home without needing (to be hospitalized).”
The Cordella sensor is placed inside the patient’s pulmonary artery using a catheter inserted into either the jugular vein in the neck or the femoral vein in the leg.
“It’s a short procedure, usually an hour or less, the patient gets the implanted sensor, and they can go home the same day,” Rowland said.
Then, each day thereafter, usually in the morning, they will wake up and place a hand-held device on their chest that energizes the implanted sensor and measures the pressure inside the heart, he explained. These pressure readings are sent remotely to the patient’s healthcare provider.
“The sensor and the system help me to personalize the treatment of my patients,” said Dr. Wilfried Mullens, principal investigator of the clinical trial and cardiologist at Oost-Limburg Hospital in Genk and the University of Hasselt. , in Belgium, in an e-mail. “As there is no ‘one size fits all’ for heart failure patients, this is very important.”
He noted that the study demonstrated that using the device not only reduced heart failure-related hospitalizations and deaths, but improved patients’ quality of life. The study found that about two-thirds of patients saw an improvement in their heart failure classification, which is based on a patient’s functional level.
The device is currently being studied in patients with class 3 heart failure (according to the New York Heart Association Functional Classification System, out of four classes in total); these patients become short of breath with minimal activity, such as walking at a normal pace. But patients with heart failure can move between classes; and those with class 2 heart failure usually walk well at a normal pace and can only run out of breath if they pick 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 usually has no symptoms and there are no activity limitations.
“Patients don’t hesitate to perform the measurements several times a week because the system is very easy to use and doesn’t take a lot of time to manipulate,” Mullens said. “They also have a sense of security because 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 United States. The company plans to complete enrollment for a 450-patient trial later this year and conduct the trial next year with the goal of obtaining FDA approval in the first half of 2024, Rowland said.
It also has competition. Namely, Abbott’s FDA-cleared CardioMEMS device uses an implantable sensor to measure the pressure inside the heart in patients with Class 3 heart failure. For patients with an implanted CardioMEMS sensor, readings are taken while lying on a “smart pillow” and then sent remotely to clinicians.
Rowland says his company’s system is more user-friendly because patients can quickly take measurements while seated using his handheld device. In the recent trial, 93% took daily readings for six months. He said a 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 hospital. and improve their quality of life.