Endotronix manufactures wireless, implantable pulmonary artery pressure sensors for monitoring chronic heart failure patients.
For most patients with heart failure today, care is episodic. Medication and other treatments are adjusted only if the patient is hospitalized or sees a doctor during regular doctor visits.But digital health and medtech startups Internal creation Attempts are being made to change that by making it easier to monitor heart failure at home.
On Sunday, the Lyle, Illinois-based company shared the results of its recent clinical trial evaluating its implantable sensor technology at the European Society of Cardiology Heart Failure Society 2022 annual meeting in Madrid, Spain. The startup’s Cordella pulmonary artery pressure sensor system was implanted in 70 heart failure patients at seven European sites in Ireland, Belgium and Germany and was found to be safe and effective in managing chronic conditions. The company announced on MondayThere were no device failures or deaths after three months, and heart failure hospitalizations were low, according to unpublished data shared by the company.
With heart failure, the pumping capacity of the organ is no longer sufficient to supply the body with enough blood and oxygen. The condition is progressive, especially without treatment, and can get worse over time. This makes it important to be able to adjust treatment to keep patients stable and out of the hospital. Endotronix co-founder and CEO Harry Rowland at the Heart Failure Association Conference.
The vast majority of patients hospitalized for heart failure have elevated pulmonary artery pressure, Rowland said. Pulmonary hypertension is a major indicator of worsening heart failure, he said.
“So if you can see these pressures rising at home a few weeks before they need urgent help, doctors can intervene — they can change the medication the patient is taking,” Rowland said. “Patients can stabilize their hearts at home without[hospitalization].”
The Cordella sensor is placed in the patient’s pulmonary artery using a catheter inserted through the jugular vein in the neck or the femoral vein in the leg.
“It’s a very short process, usually an hour or less — the patient implants the sensor and they can go home the same day,” Rowland said.
Every day after that, usually in the morning, they wake up and place a handheld device on their chest that powers the implanted sensor and measures the pressure inside the heart, he explained. These pressure readings are sent remotely to the patient’s health provider.
“Sensors and systems help me personalize treatment for my patients,” Dr. Wilfried Mullens, a cardiologist at the Oost-Limburg Hospital in Genk, Belgium, and Hasselt University in Belgium, the lead investigator of the clinical trial, said in an email. “It’s very important that there is no ‘one size fits all’ approach for HF patients.”
He noted that the study showed that using the device could not only reduce heart failure hospitalizations and deaths, but also improve patients’ quality of life. The study found that about two-thirds of patients saw an improvement in their classification of heart failure, which was based on the patient’s level of functioning.
The device is currently being studied in patients with grade 3 heart failure (based on New York Heart Association Functional Classification System, of four categories); these patients were breathless with little activity, as if walking at a normal pace. But people with heart failure can move between classes; people with grade 2 heart failure can usually walk at a normal pace, and may only be out of breath if they pick up the pace.
The study found that 41 patients with grade 3 heart failure met the criteria for grade 2 heart failure after 3 months; 5 patients met the criteria for grade 1 heart failure, when a person usually has no symptoms and has no restrictions on activity.
“Patients don’t mind taking measurements several times a week because the system is very easy to use and doesn’t take much time to process,” Mullens said. “They also feel safe because our HF team will react to the data provided.”
Endotronix still has work to do until its Cordella sensor is approved in Europe or the US. The company expects to complete enrollment for a 450-patient trial later this year and start the trial next year, targeting FDA approval in the first half of 2024, Rowland said.
It also has competition. which is, Abbott FDA-cleared CardioMEMS device Measurement of intra-cardiac pressure in patients with grade 3 heart failure using an implantable sensor. For patients with implanted CardioMEMS sensors, readings are taken by lying on a “smart pillow” and sent to clinicians remotely.
Rowland believes his company’s system is more user-friendly because patients can quickly take readings from a sitting position using their handheld device. In a recent trial, 93% read daily for 6 months. High levels of patient compliance will ultimately mean doctors have more information to better manage heart failure, so they can help keep patients out of the hospital and improve their quality of life, he said.
Photo: Endotronix
