St. Jude Medical Expands US Hospital Access to Wireless Fractional Flow Reserve Technology

St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced its wireless PressureWire(TM) Aeris technology, which aids in the diagnosis and treatment of coronary artery blockages by measuring Fractional Flow Reserve (FFR), will now be available to US hospitals using the Philips Xper Flex Cardio physiomonitoring system. Physicians will have greater access to the market’s only wireless FFR measurement system through this new Philips agreement.

FFR measurements indicate 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 helps physicians determine the best treatment options for patients during coronary interventions, such as stent procedures.

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 risk of contamination, and making the entire procedure faster and easier.

The Philips Xper Flex Cardio physiomonitoring system has been designed to streamline the overall workflow of the entire catheterization suite. A single interface on the Philips physiomonitoring 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 Philips physiomonitoring system provides availability of this important clinical data in the physician reporting module. The new product line offers a truly integrated wireless FFR solution for physicians.

Two-year follow-up data from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography inMultivessel 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 percent 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 a 14 percent reduction in health care costs to the hospital between the two patient groups after one year. These lower health care costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.

“St. Jude Medical’s FFR technology is clinically proven to significantly improve patient outcomes while reducing costs to the health care system,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “This agreement with Philips allows physicians to more easily gain access to the only wireless FFR measurement system available.”

Because of this new agreement with Philips, and existing compatibility with other recording systems including the GE Mac-Lab(R) Hemodynamic Recording System, Mennen Horizon XVu, McKesson Horizon Cardiology Hemo(TM) solution and Siemens AXIOM Sensis XP, the PressureWire Aeris technology can be used in nearly all cardiac cath labs for wireless integrated FFR measurement utilizing existing hardware.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries. 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.

Source: St Jude Medical