St. Jude Medical's CardioMems HF System Receives CMS Approval for New Technology Add-On Payment

August 5, 2014—St. Jude Medical, Inc. announced that the US Center for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for the company’s CardioMems HF system, a heart failure (HF) monitoring device. In May, the company announced that the CardioMems device was approved by the US Food and Drug Administration and the company began a strategic launch of the system. CMS will reimburse hospitals an incremental amount in addition to the Medicare Severity Diagnosis Related Group payment beginning October 1, 2014.

The company noted that the NTAP program recognizes new technologies that provide substantial clinical improvement over already-available therapies. The program is designed to support timely access to innovative technologies for Medicare beneficiaries. The CardioMems HF system had been shown to significantly reduce hospital admissions when used by physicians to manage heart failure, stated St. Jude Medical.

The CardioMems HF system provides pulmonary artery (PA) pressure data using a wireless sensor. The system uses radiofrequency energy to power the sensor and to measure PA pressure. The system consists of three components: an implantable sensor with delivery catheter, a patient electronics unit, and a PA pressure database.

St. Jude Medical stated that the system allows clinicians to monitor PA pressures to proactively manage medications and other treatment options while also providing an early indication of worsening HF.

The company noted that clinical evidence supporting the CardioMems HF system includes data from the CHAMPION trial, which demonstrated a 37% reduction in HF hospitalizations during an average follow-up duration of 15 months. In February 2011, CardioMems announced the publication of the CHAMPION results by William T. Abraham, MD, et al in The Lancet (2011;377:658–666).