St. Jude Medical and CardioMEMS have announced the US Food and Drug Administration’s (FDA) approval for the CardioMEMS heart failure (HF) monitoring device.
The CardioMEMS HF system features a wireless monitoring sensor which is implanted in the pulmonary artery (PA) during a minimally invasive procedure to directly measure PA pressure.
With the help of CardioMEMS, patients can transmit the information from their homes to their health care providers allowing for personalized and proactive management to reduce the likelihood of hospitalization.
The HF monitoring device allows clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF.
St. Jude Medical group president Dr Eric S Fain said: "The CardioMEMS HF system will not only improve the lives of patients but will also reduces the economic burden of this epidemic disease and we are delighted to have CardioMEMS become a part of St. Jude Medical."
Effectiveness of the CardioMEMS HF system has been demonstrated in the randomized, controlled CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial.
The CHAMPION clinical trial proved the effectiveness of the CardioMEMS HF system in New York Heart Association Functional Classification System class III HF patients who had been hospitalized for HF in the previous 12 months.
Compared to large-scale studies of tele-monitoring of weight, blood pressure and transthoracic impedance such as Tele-HF, TIM-HF and DOT-HF, the CHAMPION trial showed that management based on PA pressures led to a clinically significant reduction in HF admissions.
The CHAMPION study showed a statistically and clinically significant 28% reduction in the rate of HF hospitalizations at six months, and 37% reduction in HF hospitalizations during an average follow-up duration of 15 months.
St. Jude Medical invested $60m in September 2010 for acquiring 19% ownership in CardioMEMS, with an exclusive option to purchase the remaining 81% of the company for $375m.
Image: The CardioMEMS HF System features a miniaturized, wireless monitoring sensor. Photo: Courtesy of Business Wire/ St. Jude Medical, Inc.