Studies Support St. Jude Medical's FFR and LAA Closure Technology

May 19, 2016—St. Jude Medical, Inc. announced results from two cardiovascular clinical trials presented at the EuroPCR 2016 conference held May 17–20 in Paris, France. One study evaluated the impact of St. Jude Medical’s fractional flow reserve (FFR) technology on patient outcomes in acute coronary syndrome (ACS). The second study compared left atrial appendage occlusion (LAAO) therapy to standard medical treatment.

The PRIME-FFR study aimed to quantify the value of FFR when deciding the most appropriate treatment for patients with ACS. The investigators defined management strategies for patients based on angiography results before performing FFR, and then made a final treatment strategy decision after performing FFR. Results showed that management strategy reclassification after performing routine FFR was high and that FFR is safe to use in ACS patients. This indicates that a management strategy guided by FFR safely leads to changes in physician decision making.

In the second study, investigators assessed the impact of a LAAO in patients with atrial fibrillation (AF) and intracerebral hemorrhage (ICH) versus patients who received standard medical therapy. The LAAO in AF and ICH study found that patients with AF and a previous ICH who were treated with a St. Jude Medical LAAO device had a lower risk of ischemic stroke, major bleeding, and all-cause mortality compared to patients treated with standard care, suggesting that LAAO offers a major clinical benefit.

St. Jude Medical’s LAAO therapy devices include the Amplatzer cardiac plug and the Amplatzer Amulet occluder.

Lead author Jen Erik Nielsen-Kudsk, MD, stated in the company’s announcement, “Patients with AF and previous ICH have an increased risk of ischemic stroke or repeated hemorrhage. The data from this latest clinical assessment further shows that having a device like the Amplatzer LAA occlusion device implanted in these patients’ hearts offers them additional opportunity for improved cardiac health.” Dr. Nielsen-Kudsk is an Associate Professor of Cardiologic Medicine at Aarhus University in Aarhus, Denmark.