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|St. Jude Medical Announces Multiple Enhancements to Industry-Leading PressureWire FFR Measurement System|
The PressureWire Aeris and Certus provide FFR measurements, which indicate the severity of blood flow blockages in the coronary arteries. This physiological measurement helps 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 restriction.
"The PressureWire segment is one of the biggest areas of growth for St. Jude Medical's interventional business because of its clinical benefits and ability to reduce the cost of PCI procedures," said Frank Callaghan, president of St. Jude Medical's Cardiovascular Division. "We continue to invest in PressureWire technology to improve its ease-of-use and to help establish FFR measurement as a standard of care across a broader range of patients."
PressureWire Aeris Agreements:
The PressureWire Aeris system offers a secure, wireless interface between PressureWire and a cath lab's hemodynamic recording system to immediately display, measure and save FFR data. With FFR results integrated into a patient's existing study record, the severity of coronary lesions is documented together with other procedural data and angiographic imagery. The wireless technology of the PressureWire Aeris also eliminates cables crossing the sterile field, reducing variables and making the entire procedure faster and easier.
St. Jude Medical's new agreement with Siemens will enable integrated wireless FFR measurement with PressureWire Aeris as an upgrade to hospitals using the Siemens AXIOM Sensis XP. The AXIOM Sensis XP is one of the most widely used hemodynamic recording systems in cath labs and offers advanced measurement programs which aid physicians in interventional procedures.
Because of this new agreement with Siemens, and existing compatibility with other recording systems including the GE Mac-Lab(R) Hemodynamic Recording System, Mennen Horizon XVu and the McKesson Horizon Cardiology Hemo(TM) solution, the PressureWire Aeris technology can be used in the majority of cardiac cath labs for wireless integrated FFR measurement utilizing existing hardware.
Next-Generation PressureWire Certus:
The new PressureWire Certus includes modifications to design and functionality which will provide physicians with more controlled handling and versatility. It is the only guidewire on the market to offer in one wire the combined measurement of pressure and temperature which enables calculations of FFR, Coronary Flow Reserve (CFR) and an Index of Microcirculatory Resistance (IMR).
The PressureWire Certus was the only FFR measurement system used in the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which found both superior clinical outcomes and reduced healthcare costs in patients whose treatment was based on FFR.
Recently presented two-year follow-up data from the landmark FAME trial demonstrated that 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. Additionally, FFR measurement did not increase the procedural time.
FFR-guided treatment using the PressureWire system was also found to save healthcare costs, with a difference of about $2,000, or 14%, in reduced costs 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.
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 PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the interventional cardiologist in assessing 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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
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 January 2, 2010. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
SOURCE: St. Jude Medical, Inc.
St. Jude Medical, Inc.