St. Jude wins CardioMEMS addition to European cardiology guidelines, ahead of a possible NCD

St. Jude Medical CardioMEMS HF System--Courtesy of St. Jude

St. Jude Medical has been working for a couple of years to make the case for its tiny implantable heart failure monitor CardioMEMS--without much sales success thus far. But it gained a bit more fodder with the inclusion of the device to the European Society of Cardiology guidelines as a recommended tool to diagnose and treat acute and chronic heart failure.

The company has been trying to demonstrate that CardioMEMS can reduce hospital admissions and improve the quality of life for heart failure patients. And now that St. Jude ($STJ) is in the midst of a $25 billion acquisition by Abbott ($ABT) that's slated to close in the fourth quarter--the heat is really on to make the case for CardioMEMS, which is the first and only approved pulmonary artery pressure implantable monitor for heart failure.

"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," said Dr. Giovanni Battista Perego from Istituto Auxologico Italiano in Milan, Italy, in a statement.

In January, St. Jude submitted for a National Coverage Determination (NCD) for CardioMEMS from the Centers for Medicare and Medicaid Services (CMS). Acceptance of the submission is anticipated this quarter, with a decision to follow in 9 to 12 months. That would put a potential NCD for CardioMEMS into 2017. But receipt of coverage by CMS would send a solid signal to private insurers, who have been split on their reception to the monitor thus far.

In fact, St. Jude projected only $65 million in CarioMEMS sales in 2016. St. Jude acquired the product from a company of the same name in May 2014, just after the FDA approval and ahead of a CE mark that followed that December, for a total of $445 million. That includes the $60 million it had paid to buy 19% of the company in 2010.  

CardioMems is specifically approved for Class III Heart Failure patients who have a preserved Ejection Fraction (HFpEF), a category that includes about half of all heart failure patients.

In a clinical trial, CardioMEMS use reduced heart failure hospitalizations by 28% at 6 months with a 37% reduction at 15 months. St. Jude also recently published 30-day hospital readmission rates for Medicare-eligible patients that showed significant reductions.

The ESC guidelines also reference subcutaneously implanted BioMonitor 2 from Biotronik, which was approved by FDA in April to monitor and diagnose cardiac arrhythmias. Medtronic ($MDT) also markets its Linq cardiac monitor, which is the smallest cardiac monitor and is insertable. It started a trial of Linq in April that's specifically in heart failure patients. The FDA approved Linq in 2014 to monitor cardiac arrhythmias.

St. Jude expects that CardioMEMS' inclusion in the guidelines will "make this technology more widely available to benefit patients living with heart failure," said Medical Director and VP of Medical Affairs Dr. Philip Adamson.

- here is the release
- and here are the ESC guidelines