Blockages in the Heart Can Now Be Measured
New diagnostic tool combines St. Jude Medical's PressureWire Aeris with GE's Mac-Lab Hemodynamic Recording System to provide physicians with a wireless solution to aid the diagnosis and treatment of coronary artery blockages
ST. PAUL, Minn., - September 21, 2009 - St. Jude Medical, Inc. (NYSE: STJ) today announced the first use of the PressureWireTM Aeris technology, an interventional tool which measures Fractional Flow Reserve (FFR) to evaluate the severity of blood flow blockages in the arteries. This first-to-market technology helps interventional cardiologists better determine the ideal treatment option for their patients during coronary interventions, such as stent procedures. The first procedures in the U.S. were performed by Dr. Mark Zolnick at CHRISTUS St. Vincent Regional Medical Center in Santa Fe, New Mexico.
The PressureWire Aeris is a first-of-its-kind wireless FFR system which requires no additional equipment or cabling in the cardiac catheterization laboratory. Using the PressureWire Aeris technology, interventional cardiologists can accurately assess the severity of lesions. Having this information available prior to placement of coronary stents helps physicians better determine which specific lesion or lesions are responsible for a patient's ischemia, a deficiency of blood supply to the heart caused by blood restriction.
"Using the PressureWire Aeris helped me determine instantly and with certainty the best course of treatment for my patients. In the first case, I was able to decide that the narrowing of the arteries wasn't severe enough to warrant stenting, and in the next I used the FFR technology to confirm the ideal stent placement," said Dr. Mark Zolnick, a cardiologist at New Mexico Heart Institute. "The PressureWire Aeris is extremely easy to use, reduces material costs and improves patient outcomes. From both a clinical and cost effectiveness perspective, I believe that this technology should be a standard of care."
The landmark FAME trial, which compared FFR-guided treatment using St. Jude Medical PressureWire technology to stenting with angiography alone, found that in addition to saving about 11% in unnecessary material cost, instances of major adverse cardiovascular events, such as death, myocardial infarction and repeat revascularization, are reduced by 28%. The study also found that routine measurement of FFR requires no additional procedure time.
"St. Jude Medical is focused on providing physicians with technologies that aid them in making the best treatment decisions for their patients," said Frank Callaghan, president of St. Jude Medical's Cardiovascular Division. "PressureWire Aeris guides physicians to more accurately diagnose and treat their patients, significantly improving patient outcomes. Procedural set-up and workflow are also now improved, and having FFR measurements immediately accessible on existing cath lab instrumentation allows for quicker integration with patient records and a lower barrier to entry for the hospital to implement this patient-benefiting technology."
The PressureWire Aeris system integrates FFR technology directly into the Mac-Lab® Hemodynamic Recording System to immediately display, measure and save FFR data. With FFR results integrated into a patient's existing study record, this is the only system on the market where the severity of coronary lesions is documented together with other procedural data and angiographic imagery.
The Mac-Lab FFR upgrade, which is available for the XT and XTi Mac-Lab configurations, combines existing catheterization lab infrastructure, including screens, input modules and controls, with the PressureWire Aeris technology to form a seamlessly integrated FFR measurement system, resulting in improved workflow.
The wireless technology of the PressureWire Aeris also eliminates cables crossing the sterile field, reducing variables and making the entire procedure faster and easier. Physicians can remove the device's handle and insert a stent delivery system directly over the PressureWire Aeris, eliminating the time and cost of using an additional, traditional guidewire.
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. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients' heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.
The landmark trial FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation), which used St. Jude Medical PressureWire technology, was published in the Jan. 15, 2009 issue of the New England Journal of Medicine. It demonstrated a statistically significant difference of 28% in Major Adverse Cardiac Events (MACE) such as death, myocardial infarction and repeat revascularization. The randomized, prospective, multi-center trial looked at 1,005 patients with multi-vessel coronary artery disease 12 months after receiving a stent, and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.
About CHRISTUS St. Vincent Regional Medical Center
CHRISTUS St. Vincent Regional Medical Center is a community-based, private, not-for-profit hospital serving more than 300,000 people in seven counties in northern New Mexico. CHRISTUS St. Vincent was founded in 1865 by the Sisters of Charity and is New Mexico's first hospital and the largest private employer in Santa Fe. In April 2008, CHRISTUS Health and St. Vincent finalized the formation of a partnership that allowed St. Vincent to benefit from the resources of the international 40-hospital system. CHRISTUS St. Vincent is designated as a "sole community provider" by the Centers for Medicare and Medicaid Services and accredited by the Joint Commission on Accreditation of Healthcare Organizations.
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 approximately 15,000 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.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
For more information about GE Healthcare, visit http://www.gehealthcare.com.
Forward-Looking Statements (St. Jude Medical)
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 Report on Form 10-Q for the fiscal quarter ended April 4, 2009 and July 4, 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.
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