St Jude Medical’s New FFR Measuring PressureWire with Agile Tip Wins U.S. Clearance

St Jude Medical’s New FFR Measuring PressureWire with Agile Tip Wins U.S. Clearance

For Fast and Easy FFR Measurement

Performance that matches workhorse PCI guidewires with near 1:1 torque response1

Smooth, effortless stent/balloon delivery1

Better maneuverability than other pressure guidewires in in vitro testing1

2.6 times lower pressure drift per hour as compared to competitive pressure guidewires in in vitro testing2

Only PressureWire from St. Jude Medical was used in the FAME and FAME II trials

Unmatched Maneuverability1: Agile Tip

PressureWire with Agile Tip is designed to allow physicians to quickly and easily navigate tortuous vessels, which may reduce procedure time and eliminates the need for additional delivery devices.

Round tip profile with Agile Tip technology compared to previous flat wire tip

Symmetrical rotation regardless of angulation

Improved steering response in sharp bends and acute takeoffs

Superior Torque Response

PressureWire with Agile Tip enables smooth and accurate vessel navigation compared to the Volcano PrimeWire Prestige PLUS™, which demonstrates a whipping effect when torque is built up gradually before being released.1

Faster and Easier Device Delivery: Hydrophilic Coating

PressureWire with Agile Tip features a newly developed hydrophilic coating that lowers friction within guide catheters and reduces the force required to deliver a stent.1

St. Jude Medical. Data on File: R3149 PressureWire Generation 8 PMS Report.

St. Jude Medical. Data on File. Average pressure drift from 25 competitive pressure guidewires and 50 PressureWire Certus during one-hour simulated clinical use in heparinized blood.

Find out more about physiological assessment using a guidewire-mounted pressure sensor and its clinical applications. Go to the Knowledge Center.

PrimeWire Prestige is a registered or unregistered trademark of Volcano Corporation.

Incorporating FFR Measurement into Procedures Significantly Reduces Major Adverse Coronary Events

When integrated into routine lab procedures, measurement of fractional flow reserve (FFR) has been shown to reduce the incidence of adverse events in patients being treated for complex coronary artery disease. Compared to angiography alone, FFR allows physicians to more accurately identify hemodynamically relevant stenoses, reducing rates of death, myocardial infarction and repeat revascularization.1

Key findings from the FAME study show a 28% reduction in major adverse cardiac event (MACE) rates and significant cost savings — without prolonging procedure time.

1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24.

Study Reports Integrating FFR into Procedures Improves Outcomes and Reduces Costs

The FAME study, published in The New England Journal of Medicine, shows that routine measurement of FFR in patients with complex coronary artery disease reduces MACE and makes stent placement more efficient and more cost-effective.1

FAME Study Results

Study Methods

FAME (FFR versus Angiography for MultiVessel Evaluation)

Randomized, prospective study – angiography only or angiography plus FFR

20 centers in U.S. and Europe

1,005 PCI patients undergoing DES stenting for multivessel disease

Outcomes

Compared to angiography-only procedures, FAME shows that FFR:

Reduces composite rates of death, myocardial infarction, re-PCI and CABG at one year by 28%

Reduces mortality and myocardial infarction at one year by 34%

Is cost-saving and does not prolong procedure time

Decreases amount of contrast agent used

Results in similar, if not better, functional status

St. Jude Medical Announces Next-Generation PressureWire for FFR Measurement

The new PressureWire with Agile Tip provides improved handling performance during FFR measurement procedures

ST. PAUL, Minn.–(BUSINESS WIRE)–Mar. 23, 2012– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for multiple enhancements to its PressureWire™ Fractional Flow Reserve (FFR) measurement guidewire. FFR measurement identifies the severity of narrowings in the coronary arteries and allows for a more effective assessment of coronary lesions, or blockages, resulting in more accurate diagnosis and improved appropriate treatment of coronary artery blockages.

The PressureWire with Agile Tip was designed to replicate the performance of standard percutaneous coronary intervention (PCI) guidewires and delivers exceptional handling even in the most challenging anatomies. Available in both of the company’s Aeris (wireless) and Certus PressureWire models, this eighth-generation guidewire also can deliver interventional tools more easily, for faster and more cost-effective PCI.

Another new feature in the next-generation PressureWire is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons.

“In the evolution of our PressureWire family, we have long sought to match or exceed the handling performance of conventional workhorse PCI guidewires, a significant challenge owing to the presence of the pressure sensor and signal cables,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “Based on the clinical feedback obtained to date, this eighth generation family of guidewires gives us confidence we have risen to the challenge.”

When integrated into routine lab procedures, measuring FFR, as shown by the FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study, sponsored by St. Jude Medical, reduces the risk of death or heart attack by 34 percent. PressureWire technology from St. Jude Medical was used exclusively in the FAME and FAME II trials and has been proven in more than 500 additional studies. Using PressureWire Aeris or PressureWire Certus to measure FFR helps ensure access to accurate information in the cath lab, increasing the efficiency and efficacy of coronary revascularization.

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 or PressureWire Certus. 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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.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 December 31, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

The FDA has cleared a number of improvements on St Jude Medical‘s PressureWire Fractional Flow Reserve (FFR) measurement guidewire, including the new “Agile Tip” that helps navigate through difficult vasculature.

PressureWire with Agile Tip crossection St Jude Medicals New FFR Measuring PressureWire with Agile Tip Wins U.S. ClearanceThe device is available in wireless and wired models, Aeris and Certus respectively, and has an improved instrument delivery system for faster coronary interventions.

Another new feature in the next-generation PressureWire is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons.

“In the evolution of our PressureWire family, we have long sought to match or exceed the handling performance of conventional workhorse PCI guidewires, a significant challenge owing to the presence of the pressure sensor and signal cables,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “Based on the clinical feedback obtained to date, this eighth generation family of guidewires gives us confidence we have risen to the challenge.”

When integrated into routine lab procedures, measuring FFR, as shown by the FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study, sponsored by St. Jude Medical, reduces the risk of death or heart attack by 34 percent. PressureWire technology from St. Jude Medical was used exclusively in the FAME and FAME II trials and has been proven in more than 500 additional studies. Using PressureWire Aeris or PressureWire Certus to measure FFR helps ensure access to accurate information in the cath lab, increasing the efficiency and efficacy of coronary revascularization.

Source : http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1675836&highlight

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