FDA Clears First Heart Failure Monitoring Device to Reduce Readmissions

CardioMEMS Heart Failure System FDA Approval

FDA Clears First Heart Failure Monitoring Device to Reduce Readmissions

May 30, 2014 — The U.S. Food and Drug Administration (FDA) granted market clearance to the CardioMEMS Heart Failure System, the first FDA-approved heart failure (HF) monitoring device shown in clinical trials to significantly reduce hospital readmissions. The system was shown in trials to significantly reduce heart failure hospitalizations and improve quality of life in NYHA class III HF patients.

The CardioMEMS system provides physicians with daily information on heart function allowing prevention of heart failure decompensation and hospitalization. It uses a miniaturized, wireless monitoring sensor is implanted in the pulmonary artery (PA) during a minimally invasive procedure and can then directly measure PA pressure. The system allows patients to transmit this information from their homes to their healthcare providers allowing clinicians to adjust medication and pro-actively implement other treatment options to avoid hospitalization and improve the patient’s condition.

HF progression over a period of days is known as acute decompensation and leads to hospitalization. Increased PA pressures precede indirect measures of worsening HF such as increase in weight and leg swelling.

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 Lynne Warner Stevenson, M.D., director of the heart failure program at Brigham and Women’s Hospital in Boston.

Heart failure causes more than 1 million hospitalizations every year and is the most common cause of hospitalization in the United States. These frequent, unpredictable hospitalizations create a tremendous burden for patients, their families and our healthcare system and new technologies and strategies are needed to address the problem. According to the American Heart Assn., the estimated direct and indirect cost of HF in the U.S. for 2012 was $31 billion and that number is expected to more than double by 2030. Starting in 2013, Medicare is penalizing hospitals for excessive re-admissions for heart failure.

Clinical Data
The CardioMEMS HF System is supported by strong clinical evidence, including data from the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring ofPressure to Improve Outcomes in NYHA Class III Patients) trial published in The Lancet. The randomized, controlled CHAMPION clinical trial proved the effectiveness of the CardioMEMS HF System in New York Heart Association (NYHA) Functional Classification System class III HF patients who had been hospitalized for HF in the previous 12 months. In contrast 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 study showed that management based on PA pressures led to a clinically significant reduction in HF admissions. Specifically, the trial demonstrated a statistically and clinically significant 28 percent reduction in the rate of HF hospitalizations at six months, and 37 percent reduction in HF hospitalizations during an average follow-up duration of 15 months.

Unlike telemonitoring of weight and blood pressure, transthoracic impedance or intensified clinic follow-up, the CardioMEMS system has demonstrated the ability to significantly reduce heart failure hospitalizations in a large-scale clinical trial. This one-time implant, delivered using a catheter-based procedure, allows physicians to proactively manage pressures to an individually tailored target rather than reacting to symptoms once a patient’s heart failure has worsened.

The Centers for Medicare and Medicaid Services (CMS) have implemented initiatives to promote better outcomes, patient safety, and effective care by requiring hospitals to collect data on various quality metrics, most notably HF readmission rates. These data are publicly available and the purpose is to increase hospitals’ accountability for quality outcomes in order to preserve reimbursement for patient care. The CHAMPION trial demonstrates that the CardioMEMS system provides both clinical and economic benefits for healthcare in this area.

St. Jude Medical Acquisition

In September 2010, St. Jude Medical invested $60 million for 19 percent ownership of CardioMEMS, with an exclusive option to purchase the remaining 81 percent of the company for $375 million. With the FDA approval, St. Jude Medical said it now intends to immediately exercise its exclusive option to acquire CardioMEMS, and expects to complete the acquisition in the second quarter of 2014.

For more information: www.cardiomems.com