St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, and CardioMEMS, today announced U.S. Food and Drug Administration (FDA) approval of the CardioMEMS™ HF System. The CardioMEMS HF System is the first and only FDA-approved heart failure (HF) monitoring device that has been proven to significantly reduce HF hospital admissions when used by physicians to manage heart failure.
The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery. (Photo: Business Wire)
The CardioMEMS HF System uses a miniaturized, wireless monitoring sensor that is implanted in the pulmonary artery (PA) during a minimally invasive procedure to directly measure PA pressure. Directly measuring PA pressure via a procedure called a right-heart catheterization is a standard-of-care practice for managing worsening HF in patients who have been hospitalized. The CardioMEMS HF System allows patients to transmit the same information from their homes to their health care providers allowing for personalized and proactive management to reduce the likelihood of hospitalization. Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands and blood pressure within the heart is elevated. Significant HF progression over a period of days is known as acute decompensation and leads to hospitalization. Increased PA pressures often precede indirect measures of worsening HF such as weight and blood pressure changes. The CardioMEMS HF System allows clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF. “I believe this strategy has the potential over time to change heart failure. Not just to lighten the burdens every day or to decrease the number of hospitalizations, but to decrease the grim progression of the disease,” said Dr. Lynne Warner Stevenson, director of the Heart Failure Program at Brigham and Women’s Hospital in Boston.