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(TM) HF System.
St. Paul, Minn.: 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 beneficiaries.
"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.
Forward-Looking Statements
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.