St. Jude Medical Announces FDA Clearance and Launch of the New PressureWire X Guidewire Designed to Optimize PCI Procedures in Patients With Complex Anatomies

The St. Jude Medical fractional flow reserve technology has demonstrated improved patient outcomes and reduced costs associated with percutaneous coronary intervention procedures

St. Jude Medical PressureWire™ X Guidewire (Photo: Business Wire)

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ST. PAUL, Minn.--()--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the U.S. clearance and launch of the company’s new PressureWire™ X Guidewire fractional flow reserve (FFR) measurement system. The latest generation of the pioneering PressureWire™ Guidewire system is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma, with the accuracy and simplicity physicians expect when treating patients during percutaneous coronary intervention (PCI), especially those with complex anatomies.

A PCI procedure, or coronary angioplasty, is a non-surgical procedure designed to open coronary blood flow blockages and restore blood flow to the hearts of patients living with coronary artery disease (CAD)—the most common type of heart disease. PressureWire Guidewire FFR measurements are used by physicians to identify the severity of narrowings in the coronary arteries, which can result in more accurate diagnoses and improved treatment decisions for their patients. Although there are approximately 900,000 PCI procedures performed annually in the United States, only one in five of those are performed using FFR guidance.

“For years, clinical research has confirmed that fractional flow reserve is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention,” said Dr. Annapoorna Kini, the director of the cardiac cath lab and the director of the interventional fellowship program at Mount Sinai Medical Center New York, NY. “The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”

The use of FFR to optimize PCI is supported by strong evidence, and continues to be a topic of multiple clinical studies. In addition to launching the latest PressureWire Guidewire, St. Jude Medical has also launched the PRESSUREwire REGISTRY (Practical Evaluation of Fractional Flow Reserve (FFR) and its Association Alternate Indices During Routine Clinical Procedures), a multicenter clinical trial to determine the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome (ACS), a major cause of global morbidity and mortality.

The PRESSUREwire REGISTRY will build upon clinical trials designed to assess the positive outcomes associated with FFR technology, such as the St. Jude Medical sponsored FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trials, which found that St. Jude Medical PressureWire guidewire technology can improve patient outcomes over angiography alone in patients with CAD.

The St. Jude Medical FAME trial body of evidence also demonstrated reductions in the risk of death or heart attack in patients undergoing PCI, as well as reduced health care costs for patients whose treatment was guided by FFR technology. Primary outcome two-year data from the FAME 2 trial showed that in patients with at least one significant coronary blockage with an FFR value of at least .80, FFR-guided PCI plus medical therapy reduced urgent revascularization by 77 percent compared to medical therapy alone. In 2015, five-year data from the FAME study confirmed the sustained, long-term benefits of FFR-guided PCI over angiography-guided intervention.

“St. Jude Medical strives to provide physicians with fractional flow reserve pressure guidewire technology that is backed by ample clinical data and that matches the handling performance of conventional PCI guidewires,” said Dr. Mark Carlson, chief medical officer and vice president of global medical affairs at St. Jude Medical. “The new PressureWire X Guidewire shows our dedication to providing physicians with cost-effective, easy-to-use technologies that aid them in making the best treatment decisions for their patients. In turn, patients can have peace of mind knowing their physicians have more confidence in their readings.”

About Fractional Flow Reserve

Fractional flow reserve is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire™ Guidewire FFR measurement systems. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced health care costs.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

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, reimbursement strategies, 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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
Investor Relations
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Laurel Hood, 651-756-2853
LHood02@sjm.com

Release Summary

St. Jude Medical announces FDA clearance and launch of PressureWire X Guidewire. St. Jude Medical FFR technology has demonstrated improved patient outcomes and reduced costs associated with PCI.

Contacts

St. Jude Medical, Inc.
Investor Relations
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Laurel Hood, 651-756-2853
LHood02@sjm.com