Healthcare Industry News:  neuromodulation 

Devices Interventional Cardiology

 News Release - March 30, 2009

St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution

UPPSALA, Sweden & WAUKESHA, Wis. & ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) and GE Healthcare today announced the worldwide commercial launch of the first fully integrated wireless solution for the measurement of Fractional Flow Reserve (FFR).

The new FFR solution, seamlessly integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup.

The solution is based on the PressureWire® Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE’s Mac-Lab® hemodynamic recording system, a system used to record and display physiological parameters in the coronary cathlab. PressureWire Aeris was developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical and is now part of the Company’s Cardiovascular Division.

The Mac-Lab FFR upgrade utilizes existing cathlab infrastructure, including screens, input modules and controls, and together with the PressureWire Aeris technology forms a seamlessly integrated FFR measurement system for greatly improved cathlab workflow and ease of use.

“The PressureWire Aeris system represents a true paradigm shift in our thinking about the accessibility of FFR,” said Augusto Pichard, M.D., professor of medicine, Cardiology, and director of cardiac cath labs, Washington Hospital Center, Washington, D.C. “The integration with our existing GE hemodynamic recording system means that traditional limitations of FFR measurements, including utilizing a stand alone machine for calculation, are removed.”

With all FFR results integrated into the existing physiological information archive, this new solution is also the only system on the market where the hemodynamic severity of coronary lesions, as measured by FFR, is documented together with other procedural data and angiographic imagery, creating a more complete patient record.

"Combining the strength of GE's Mac-Lab hemodynamic recording system with the performance of PressureWire Aeris in the assessment of FFR has the potential to enhance clinical workflow tremendously," said Omar Ishrak, president and chief executive officer of GE Healthcare Systems. "We are pleased to offer a tool which enables the interventional cardiologist to guide coronary procedures with higher accuracy, improving long term patient outcomes and lower procedural cost."

The Mac-Lab FFR solution is available as an upgrade path to all existing GE Mac-Lab installations worldwide, as well as new installations.

"The incorporation of FFR and PressureWire Aeris into GE Mac-Lab is a major advancement as we work to make FFR standard of care in the interventional cathlab. With FFR available directly in the existing hemodynamic recording system the need for additional equipment is removed and the procedure setup is reduced to the flip of a switch," said Anders Qvarnström, vice president and general manager of the St. Jude Medical Cardiovascular Division in Sweden. "FFR is a highly valuable clinical tool for the interventional cardiologist, guiding the PCI procedure for improved patient outcomes and lowered cost. The combination of our innovative wireless PressureWire Aeris and the Mac-Lab FFR upgrade makes this tool readily available in a large number of cathlabs worldwide.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary vasculature and it is measured by PressureWire Aeris. FFR specifically identifies which individual coronary narrowing is 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), published in the Jan. 15 issue of the New England Journal of Medicine, demonstrated a statistically significant 30 percent difference 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.

The FAME study, in which pressure guidewires from Radi Medical Systems were exclusively used, also showed that FFR measurement is cost-saving and does not add time to the procedure.

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 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.

About Radi Medical Systems

Radi Medical Systems develops, manufactures and sells medical devices designed to improve patient care. The company’s pioneering work in the field of interventional cardiology has resulted in market-leading intravascular sensors and hemostasis management devices. The company was acquired by St. Jude Medical in December 2008, and is now part of the Cardiovascular Division of St. Jude Medical. For more information, please visit www.radi.se.

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 our website at http://www.gehealthcare.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 Annual Report on Form 10-K for the fiscal year ended January 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.


Source: St. Jude Medical

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