FDA approves CardioMEMS heart failure management system

28 May 2014 (Last Updated May 28th, 2014 18:30)

St Jude Medical and CardioMEMS have received approval from the US Food and Drug Administration for the CardioMEMS HF System.

CardioMEMS HF system

St Jude Medical and CardioMEMS have received approval from the US Food and Drug Administration for the CardioMEMS HF System.

Claimed to be the first and only FDA-approved heart failure (HF) monitoring device, the CardioMEMS HF System has been proven to reduce HF hospital admissions when used by physicians to manage heart failure.

The 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.

The method of measuring PA pressure is known as right-heart catheterisation, which is a standard-of-care practice for managing worsening HF in patients who have been hospitalised.

The system allows patients to transmit the same information from their homes to their healthcare providers, enabling personalised and proactive management to reduce the likelihood of hospitalisation.

HF occurs when the heart is unable to pump enough blood to meet the body's demands and blood pressure within the heart is elevated and significant HF progression over a period of days is called as acute decompensation and leads to hospitalisation.

"The CardioMEMS HF System will not only improve the lives of patients, but will also reduce the economic burden of this epidemic disease."

The company said that increased PA pressures often precede indirect measures of worsening HF such as weight and blood pressure changes.

According to the company, the CardioMEMS HF System will enable clinicians to stabilise PA pressures by proactively managing medications and other treatment options, as well as provide an early indication of worsening HF.

St Jude Medical group president Eric Fain 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."

The CardioMEMS HF System is supported by strong clinical evidence, including data from the randomised, controlled CHAMPION trial, which proved its effectiveness in New York Heart Association (NYHA) Functional Classification System class III HF patients who had been hospitalised for HF in the previous 12 months.

CardioMEMS founder and CEO Jay Yadav said: "The CardioMEMS system creates a new paradigm for proactive management of heart failure and will greatly benefit patient:s 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."


Image: The CardioMEMS HF System uses a miniaturised, wireless monitoring sensor that is implanted in the pulmonary artery. Photo: courtesy of Business Wire.