CardioMEMS Heart Failure Monitoring System Receives Approval from CMS for
New Technology Add-On Payment
St. Jude Medical’s CardioMEMS HF System demonstrates our commitment to
delivering high-quality, innovative solutions that reduce health care costs
and improve outcomes for patients
ST. PAUL, Minn. -- August 5, 2014
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today
announced that the Center for Medicare and Medicaid Services (CMS) has
approved a New Technology Add-on Payment (NTAP) for the CardioMEMS^™ HF
System. The CardioMEMS HF System is the first and only U.S. Food and Drug
Administration approved heart failure (HF) monitoring device that has been
proven to significantly reduce hospital admissions when used by physicians to
manage heart failure. The NTAP program, which recognizes new technologies that
provide substantial clinical improvement over already available therapies, is
designed to support timely access to innovative technologies for Medicare
“We are pleased CMS recognizes the substantial clinical benefit provided by
the CardioMEMS HF System,” said Eric S. Fain, M.D., group president of St.
Jude Medical. “This favorable decision helps ensure that Medicare patients
have access to this innovative technology as we introduce CardioMEMS as a new
treatment paradigm to proactively manage heart failure, improve patient
outcomes and reduce hospital admissions.”
Beginning October 1, 2014, CMS will reimburse hospitals an incremental amount
in addition to the Medicare Severity Diagnosis Related Group (MS-DRG) payment.
For more information on the CMS NTAP approval for the CardioMEMS HF System,
please visit the CMS website.
More than 5 million Americans suffer from HF, which leads to 1 million
hospitalizations and 2.8 million office and emergency department visits a
year, and is a significant economic burden for hospitals and society.
Approximately $31 billion is spent annually on HF in the U.S. and this cost is
projected to more than double to $70 billion by 2030.
The CardioMEMS HF System allows clinicians to monitor pulmonary artery (PA)
pressures in order to proactively manage medications and other treatment
options while also providing an early indication of worsening HF. The
CardioMEMS HF System is supported by strong clinical evidence, including data
from the CHAMPION (“CardioMEMS Heart Sensor Allows Monitoring of Pressure to
Improve Outcomes in NYHA Class III Patients”) trial published in The Lancet.
The CHAMPION trial demonstrated a 37 percent reduction in HF hospitalizations
during an average follow-up duration of 15 months.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive epidemic
diseases. The company does this by developing cost-effective medical
technologies that save and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical
focus areas that include cardiac rhythm management, atrial fibrillation,
cardiovascular and neuromodulation. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. Such forward-looking statements include the expectations, plans
and prospects for the Company, including potential clinical successes,
anticipated regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by the
Company are based upon management’s current expectations and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors beyond the
Company’s control and the risk factors and other cautionary statements
described in the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the Company’s Annual
Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly
Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Kristi Warner, 651-756-2085
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