St Jude and CardioMEMS FDA-approval of heart failure device
St. Jude Medical and CardioMEMS have announced US Food and Drug Administration (FDA) approval of the CardioMEMS Heart Failure 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 miniaturised, 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 catheterisation is a standard-of-care practice for managing worsening HF in patients who have been hospitalised. The CardioMEMS HF system allows patients to transmit the same information from their homes to their health care providers allowing for personalised and proactive management to reduce the likelihood of hospitalisation.
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 hospitalisation. Increased PA pressures often precede indirect measures of worsening HF such as weight and blood pressure changes. The CardioMEMS HF system allows clinicians to stabilise 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.
Eric Fain, group president of St. Jude Medical, congratulates CardioMEMS on this historic accomplishment in the treatment of heart failure and said: “The CardioMEMS HF system will not only improve the lives of patients but will also reduce the economic burden of this epidemic disease and we are delighted to have CardioMEMS become a part of St. Jude Medical.”
“We want to thank the patients and clinicians who worked with us to prove the benefit of the CardioMEMS HF system. We also want to thank FDA for making this technology available to heart failure patients in the United States,” said Jay Yadav, founder and ceo of CardioMEMS. “The CardioMEMS system creates a new paradigm for proactive management of heart failure and will greatly benefit patients and their families. We are excited to be working with St. Jude Medical, whose geographic reach and focus in the area of heart failure will bring this much needed treatment to patients around the world.”