Healthcare Industry News:  neuromodulation 

Devices Interventional Cardiology

 News Release - September 23, 2009

FAME Trial Two-Year Follow-Up Results Demonstrate Continued Reduction in Risk of Death or Heart Attack When Physicians Use St. Jude Medical Fractional Flow Reserve Technology Prior to Implanting Coronary Stents

Trial Demonstrates an FFR-Guided Strategy to Treat Multivessel Coronary Artery Disease Both Improves Outcomes and is Cost-Saving Compared to Procedures Using Angiography Alone

ST. PAUL, Minn., Sept. 23--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced that the two-year results from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial demonstrated the durability of the improved outcomes noted at one-year for patients with multivessel coronary artery disease whose treatment was guided by FFR rather than by standard angiography alone. Two-year results demonstrated that the risk of death or myocardial infarction (heart attack) was 34% lower for patients whose treatment was guided by St. Jude Medical’s PressureWire technology prior to coronary stenting.

The two-year results demonstrated that patients who received FFR-guided treatment had increasingly superior outcomes over time; the two patient groups had a difference in patient death and myocardial infarction of 3.8% after 12 months and 4.3% after two years.

Study results also showed that at two years:
  • The risk of a patient dying or having a heart attack was reduced by approximately 34% when FFR measurement was performed prior to stenting. (12.7% for the angiography-guided group compared to 8.4% for the FFR-guided group.)
  • The risk of a patient having a heart attack was 6.1% for the FFR-guided group, compared to 9.7% in the control group, a reduction of 37%
  • Only one out of 513, or 0.2%, of deferred lesions resulted in a late myocardial infarction
  • Use of FFR technology did not increase average procedural times
After one year, FFR-guided treatment was also demonstrated to be cost-saving, with a difference of about $2,000, or 14%, between total healthcare costs for the FFR-guided cohort and the group treated by angiography alone. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.

“The two-year data from the FAME study continue to show improved outcomes when multivessel coronary stenting is guided by measurement of FFR,” said co-principal investigator of the FAME study William F. Fearon, M.D., associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, Calif. “Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money.”

The FAME study was a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography 12 months after receiving a stent. The two-year results from the study, which exclusively used St. Jude Medical’s PressureWire™ Certus technology to measure FFR, were presented today at a late-breaking clinical trial at TCT 2009, the annual scientific symposium of the Cardiovascular Research Foundation. The 12-month results from the FAME study were published in the January 15, 2009 issue of the New England Journal of Medicine.

St. Jude Medical’s FFR technology, which includes both the PressureWire Certus and the PressureWire™ Aeris, is one example of the company’s focus on developing products which aid physicians in practicing medicine more proactively. The PressureWire technology enables physicians to pinpoint which specific lesion or lesions are responsible for a patient’s ischemia, giving them the information upon which they can determine the best treatment option for each patient. The PressureWire Aeris, which was recently launched in the U.S., uses wireless technology, removing the need for cables to cross the sterile field, introducing fewer variables and making the entire procedure faster and easier.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. Attended by over 10,000 participants each year, TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field of interventional cardiovascular medicine.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries as measured by PressureWire Certus and 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.

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

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 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.

Source: St. Jude Medical

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