The European Society of Cardiology has added St. Jude Medical‘s (NYSE:STJ) CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure patients,” the company said today.
The CardioMems device consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the vessel. The device is designed to help physicians manage patients’ medication to control their heart failure before visible changes to weight or blood pressure occur.
The new guidelines, published this year, support the use of pulmonary artery pressure monitoring with the CardioMems HF system for the diagnosis and treatment of acute and chronic heart failure, St. Jude said.
“The ESC guideline for the CardioMEMS HF System provides direction for physicians who are working to appropriately treat our heart failure patients and reduce their risk of repeated heart failure hospitalizations,” Dr. Giovanni Perego of Milan, Italy’s Istituto Auxologico Italiano said in a press release.
The company said data from the Champion study of the device served as a base for the updated guideline, which the company says applies to all Class II heart failure patients, regardless of their ejection fraction.
“We are very pleased to see the CardioMEMS HF System was included in the guidelines and congratulate the European Society of Cardiology for working to make this technology more widely available to benefit patients living with heart failure,” medical affairs veep Dr. Philip Adamson
The addition is a big win for St. Jude, after a Medicare contractor in February said it would not cover the CardioMEMS implantable heart monitor, citing the need for more clinical data on the device.
Novitas, a Medicare Administrative Contractor that covers patients in Pennsylvania, New Jersey, Maryland, Delaware, Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, Mississippi and and Washington, D.C., said it would not cover the CardioMEMS device, which is designed to monitor patients for signs of heart failure.
In November 2015, St. Jude put another brick in the wall of its defense of the CardioMEMS device, touting data from the Champion trial showing lower hospitalization rates for patients treating using data from the CardioMEMS device.
In September 2015, 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.
