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POST-IT Clinical Registry Demonstrates Importance of St. Jude Medical Fractional Flow Reserve Technology at EuroPCR 2014

May 22, 2014

Analysis of more than 900 patients enrolled in real-world registry demonstrates improved clinical decisions when FFR is used to guide cardiac treatment procedures

ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results from the POST-IT (Portuguese Study on the Evaluation of FFR Guided Treatment of Coronary Disease) registry were presented during a hot line late-breaking clinical trial session at EuroPCR 2014. Data from the registry, which was sponsored by the Portuguese Association of Cardiovascular Interventions, demonstrated that the use of St. Jude Medical PressureWire™ fractional flow reserve (FFR) technology changed the course of treatment for approximately half of the patients with coronary artery disease (CAD), thus ensuring patients with ischemia-producing narrowings received appropriate therapy.

“Data from the POST-IT registry provides further evidence of the benefits associated with FFR measurement technology in a real-world setting,” said Sergio B. Baptista, M.D., of Hospital Fernando Fonseca in Amadora, Portugal, a principal investigator of the POST-IT study. “The results demonstrate that FFR-guided therapy adds important information that alters the current treatment strategy within the cardiology community for PCI procedures, furthering my belief that FFR should become the standard of care for treating patients with coronary artery disease.”

POST-IT is a national, prospective, multi-center registry that enrolled 918 eligible patients at 19 centers in Portugal. Data from the registry highlighted the potential clinical and economic benefits of FFR measurement across a wide range of patients with both stable and unstable coronary artery disease. Results demonstrated that use of PressureWire FFR measurement systems results in improved treatment strategies for patients, with FFR changing the treatment strategy for more than 400 patients or 44.3 percent. Further, the registry found more patients were appropriate candidates for percutaneous coronary interventions (PCI) when assessed with FFR-guided therapy, increasing the number of patients referred for PCI from 35 percent to 43 percent.

“Collectively, these findings show that when FFR-guided therapy is used, cardiologists can significantly improve patient management,” said LuÍs F. Raposo, M.D., of Hospital de Santa Cruz in Carnaxide, Portugal, co-principal investigator of the POST-IT study. “The findings also suggest that FFR reduces costs to healthcare systems due, in part, to its ability to eliminate further non-invasive tests and potential future procedures.”

“St. Jude Medical welcomes the abundance of positive data that continues to demonstrate the profound role FFR has on improving patient care,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “There have long been questions about whether patients are in need of a stent or if they would have better results with medical therapy alone. These significant new data reaffirm findings from previous clinical trials, including the landmark FAME trials and the RIPCORD study, which demonstrated that patients who received FFR-guided therapy ultimately can have better outcomes than those who received standard angiography alone.”

POST-IT Registry Protocol

The POST-IT registry required all patients to first undergo a coronary angiogram. Based on the results of the coronary angiography, the supervising cardiologist was asked to create an initial management plan for each patient, based on all available information. Once the original treatment plan was finalized, patients underwent FFR assessment of all vessels suitable for revascularization (whether PCI or CABG), which were defined as those =2.25 mm. After FFR results were known, the supervising cardiologist was then asked to revise their final treatment decision. Consistency between the final and initial management plans were then evaluated.

About FFR

FFR 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™ Aeris. 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, which can result in improved patient outcomes and reduced healthcare costs.

To learn more about FFR-guided therapy or see a demo of the PressureWire™ fractional flow reserve (FFR) measurement technology, EuroPCR attendees can visit St. Jude Medical at booth F16.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer 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 has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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, 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 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 29, 2014. 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

Investor Relations

jweigelt@sjm.com

or

Kate Stoltenberg, 651-756-3388

Media Relations

kstoltenberg@sjm.com

Source: St. Jude Medical, Inc.


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