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

* Reuters is not responsible for the content in this press release.

Mon Mar 30, 2009 8:00am EDT

UPPSALA, Sweden & WAUKESHA, Wis. & ST. PAUL, Minn.--(Business Wire)--
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. 



St. Jude Medical
Angela Craig, 651-481-7789
Investor / Media Relations
acraig@sjm.com
or
Radi Medical Systems
Iohn Ryott, +46-18-161000
Media Relations
John.ryott@radi.se
or
GE Healthcare
Corey Miller, +1-414-469-5499
Media Relations
corey.miller@ge.com



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.