ST. PAUL, Minn.--(BUSINESS WIRE)--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.
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.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Kristi Warner, 651-756-2085