|CardioMEMS's HF System for monitoring heart failure--Courtesy of St. Jude Medical|
St. Jude Medical ($STJ) touted a new study published in the Journal of the American College of Cardiology: Heart Failurethat was supportive of its CardioMEMS Heart Failure Monitor, based on a new analysis of its pivotal clinical trial, which led to FDA approval in 2014.
The analysis showed that the device can improve medication management, and thereby cut heart failure hospitalizations, St. Jude said. It also validated the guidance in the clinical trial about proper use of the device, according to a release.
Proper usage is key, because the preventative, data-intensive treatment paradigm for heart failure is a new one for doctors. Institutions that adopt the CardioMEMS have typically had to assign a sign nurse to monitor the constant stream of individual-patient heart data, and alert docs when there is a signal of deterioration in a patient's condition.
As such, the findings in the study have been made before (after all, the device's clinical trial found that it led to a 37% reduction in hospitalization over about 15 months), but St. Jude needs all the positive data and affirmation that it can get to help it overcome poor (or nonexistent) reimbursement for the device.
In spite of the potential for downstream savings in the form of fewer hospitalizations, regional Medicare Administrative Contractors have been hesitant to cover the device on behalf of Medicare, leading to disappointing sales. Two MACs have said they will not reimburse the device at all, meaning it is not covered in 12 states and the District of Columbia.
In response, St. Jude has filed for a National Coverage Decision with the Centers for Medicare & Medicaid Services. A positive decision would guarantee nationwide Medicare coverage of the device.
St. Jude also talked up an independent study from a New York healthcare system during the annual meeting of the American College of Cardiology, which showed patients who were implanted with the company's CardioMEMS heart failure monitoring implant experienced a plethora of benefits.
Northwell Health's analysis of 66 patients found that the 34 patients who were implanted with the CardioMEMS scored better on a quality-of-life questionnaire, had a 7% reduction in body weight, and increased the distance they could walk in 6 minutes by 38%.
Data about heart health from the CardioMEMS implant are viewable by doctors via St. Jude's online patient care network. They can use the information to proactively adjust medications or make other changes to therapy in real time.