CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around
This article was originally published in The Gray Sheet
FDA’s Circulatory System Devices panel wrestled with a new analysis of the CHAMPION trial of the Champion heart failure monitor Oct. 9. CardioMEMS was banking that the new analysis would eliminate the doubts about possible bias that undermined the company’s first effort to earn FDA approval in 2011.
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FDA approved the CardioMEMS HF wireless heart-failure monitor, and St. Jude has exercised its option to buy the technology and its manufacturer. The approval is based on the results of the CHAMPION pivotal trial, which showed that patients monitored with the remote, implantable system needed fewer hospitalizations.
The Medicare agency is questioning whether Boston Scientific’s Watchman stroke device or the CardioMEMS implantable heart failure monitor, championed by St. Jude Medical, can meet the “substantial clinical improvement” threshold to qualify for an inpatient new-technology add-on payment.
Among the latest round of applicants announced Dec. 26 for the hospital inpatient, new-technology add-on payments are five device makers: Boston Scientific (Watchman), CardioMEMS (Champion HF), Abbott Vascular (MitraClip), NeuroPace (RNS), and Aptus Endosystems (Heli-FX EndoAnchor).