St. Jude Medical (NYSE:STJ) put another brick in the wall of its defense of the CardioMEMS heart failure monitor, which was assailed earlier this year by claims that the device is not cost-effective.
New data from the St. Paul, Minn.-based company’s 550-patient Champion trial, published online yesterday in The Lancet, showed lower hospitalization rates for patients treating using data from the CardioMEMS device.
The trial compared patients treated using CardioMEMS with standard care for heart failure, with a primary outcome of hospital admissions. After the last patient enrolled completed 6 months of follow-up for an average of 18 months, some 170 subjects were transferred to the treatment arm for a 2-year open enrollment phase averaging 13 months.
The initial control group showed a 33% reduction in hospitalizations, while there was a 48% reduction for patients from the control group who moved to the treatment arm. There were 8 (1%) device-related or system-related complications and 7 (1%) procedure-related adverse events, according to the study.
“This rigorous analysis showed a dramatic, long-term impact for high-risk patients who were managed with the CardioMEMS HF system,” medical affairs VP Dr. Philip Adamson said in prepared remarks. “During the 1st 18 months, the control group hospitalization rates remained high, but once patient management using pressure data from the CardioMEMS HF system was introduced for the 1st time, we saw a hospitalization reduction of almost 50%, a clinically and highly statistically significant result.”
“Despite advances in medical care, a significant number of heart failure patients are readmitted to the hospital within a relatively short period of time and every hospitalization is very traumatic for those patients and their families,” added lead author Dr. William Abraham of Ohio State University’s Wexner Medical Center. “The longitudinal analysis shows an important reduction in these admission rates when patients are monitored with the CardioMEMS HF system.”
It’s timely news for St. Jude, which acquired CardioMEMS for $435 million after the heart failure monitor won FDA approval last year. In September, a study from the non-profit Institute for Clinical and Economic Review in Boston found that the CardioMEMS device may not be a cost-effective solution for patients with congestive heart failure, saying it’s priced about $10,000 higher than ICER’s “value-based price benchmark” of $7,622. Including intervention costs and potential savings on a population basis, the annual cost of the device “exceeds the potential budget impact threshold at which excessive cost burdens would be placed on the overall health care system,” ICER reported. The ICER report also found there to be a “low certainty of a small net benefit” for the system compared to alternatives for managing the disorder, according to the report. The group questioned the device’s impact on mortality and its performance in a setting outside the Champion trial.
Last month, the FDA warned St. Jude about process issues at the Atlanta plant where the CardioMEMS implant is made. A spokeswoman for St. Jude told MassDevice.com via email that the federal safety watchdog flagged the issues before it began to integrate the CardioMEMS operation into its global quality system. The company has since addressed most of the issues to the FDA’s satisfaction and is “working diligently” to close out the rest, she wrote.