Hemodynamic sensor for management of HF receives expanded indication from FDA
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Abbott announced its sensor providing hemodynamic-guided management of patients with HF has received an expanded indication from the FDA.
The system (CardioMEMS) is now indicated for patients with NYHA class II HF and patients with blood tests confirming elevated levels of natriuretic peptides, according to a press release from the company. The system was previously indicated for patients with NYHA class III HF with at least one HF hospitalization in the prior year.
“Class II patients, while they may have milder symptoms, are at significant risk for heart failure admissions that are not benign,” J. Thomas Heywood, MD, director of advanced HF and co-director of the Pulmonary Hypertension Program at Scripps Clinic, told Healio. “Most heart failure patients do not understand the severity of a hospital admission, which increases a person’s mortality rate by 25% to 30% in the year following an admission. A physician’s role is to avoid decompensation in heart failure that leads to these types of admissions. The Abbott CardioMEMS HF system has been shown to do this.”
The sensor is implanted into the pulmonary artery via a minimally invasive procedure and monitors for changes in pulmonary artery pressure that indicate worsening HF, which may enable clinicians to change management of therapy before hospitalization is necessary, according to the release.
The expanded indication was based on results of the GUIDE-HF trial. As Healio previously reported, in an analysis of data from before the onset of the COVID-19 pandemic, the CardioMEMS system reduced a composite of HF hospitalization, emergency visits and mortality in patients with class II, III or IV HF and a previous HF hospitalization or elevated natriuretic peptides.
“Since we will now be able to offer the CardioMEMS HF system to heart failure patients earlier in their disease course, we have a greater chance of preventing the first heart failure admission, not just the second,” Heywood told Healio. “The CardioMEMS HF system offers an important patient benefit, as it allows us to monitor heart failure patients very well in the comfort and safety of their own homes. It allows us to keep them at home and out of the hospital.”
For more information:
J. Thomas Heywood, MD, can be reached at heywood.james@scrippshealth.org.
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