ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. announced today its wireless PressureWire™ Aeris technology, which aids in the diagnosis and treatment of coronary artery blockages by measuring Fractional Flow Reserve (FFR), will now be available to hospitals using the McKesson Horizon Cardiology Hemo™ solution. Through a new agreement with McKesson, physicians will have greater access to the market’s only wireless FFR measurement system.
FFR measurement indicates the severity of blood flow blockages in the coronary arteries, allowing physicians to better identify which specific lesion or lesions are responsible for a patient’s ischemia, a deficiency of blood supply to the heart caused by blood flow restriction. The PressureWire Aeris technology will help physicians determine the best treatment option for their patients during coronary interventions, such as stent procedures.
The PressureWire Aeris is a first-of-its-kind wireless FFR measurement system which requires no additional equipment or cabling in the cardiac catheterization laboratory. The elimination of additional equipment and cabling has the potential to simplify set-up and increase procedural efficiencies.
The PressureWire Aeris wireless technology works by integrating physiological lesion assessment directly into the hemodynamic recording system already available in the cath lab to immediately display, measure and save FFR data. This integration is an optional module for hospitals using McKesson’s Horizon Cardiology Hemo system version 12.1. The McKesson Horizon Cardiology Hemo system was designed to improve the overall workflow of the entire catheterization suite. A single interface in the Horizon Cardiology Hemo system combines both the FFR measurement controls and clinical documentation including lesion, stage and medication. This unique integration between the PressureWire Aeris wireless technology and the Hemo system v 12.1 provides availability of this important clinical data in the physician report and registry submission modules.
Two-year follow-up data from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) trial compared FFR-guided treatment using a St. Jude Medical PressureWire to treatment using standard angiography alone, and found both superior clinical outcomes and reduced healthcare costs in patients whose treatment was based on FFR. The combined risk of death or myocardial infarction (heart attack) was 34% lower for patients whose treatment was guided by PressureWire technology prior to coronary stenting.
FFR-guided treatment using the St. Jude Medical PressureWire System was also found by the FAME trial to be cost-saving, with a difference of about $2,000, or 14%, in healthcare costs to the hospital between the two patient groups after one year. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.
“The data from the FAME study demonstrate that compared to angiography alone, St. Jude Medical’s FFR technology significantly improves patient outcomes while reducing costs to the healthcare system,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “Through the integration of PressureWire Aeris with McKesson’s cath lab recording systems, even more physicians will now have access to this patient-benefiting and cost-saving technology.”
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries, and it is measured by the PressureWire Aeris and PressureWire™ Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patients’ heart muscle (called ischemia), and guides the interventional cardiologist in assessing and determining which lesions warrant coronary interventions which results in improved treatment outcomes.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
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 Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Contact:
St. Jude Medical, Inc. Investor Relations: Angie Craig, 651-756-2191 acraig@sjm.com or Media Relations: Marisa Bluestone, 651-756-6739 mbluestone@sjm.com
