Cardiac Interventions Today

Preliminary FAME II Data Support Superiority of FFR-Guided PCI to Medical Therapy

May 15, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced that a significant difference in the need for urgent revascularization was shown when fractional flow reserve (FFR)-guided assessment was used to direct treatment in patients with stable coronary artery disease, according to preliminary data from the FAME II (FFR-Guided Percutaneous Coronary Intervention [PCI] plus Optimal Medical Treatment [OMT] vs Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial. The statistically significant results, presented at a late-breaking trial session at the EuroPCR 2012 conference in Paris, validate the important role that FFR-guided therapy has in improving patient outcomes, the company stated in a press release.

REPRISE I Data Presented for Boston Scientific’s Lotus TAVR Device

May 15, 2012—Boston Scientific Corporation (Natick, MA) announced that results from the REPRISE I trial were presented at the EuroPCR 2012 conference in Paris. REPRISE is evaluating the acute safety of the transcatheter Lotus aortic valve system in patients with severe aortic valve disease. The data demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge, advised the company.

Three-Month DAPT Duration Approved in EU for Abbott Vascular’s Xience DES

May 15, 2012—Abbott Vascular (Santa Clara, CA) issued a press release announcing that the company’s Xience Prime and the Xience V everolimus-eluting coronary stent systems have received European CE Mark approval for use with dual-antiplatelet therapy (DAPT) for at least 3 months after stent implantation in patients with coronary artery disease.

St. Jude Medical Gains CE Mark Approval for the Enlightn Renal Denervation System

May 15, 2012—St. Jude Medical, Inc. (St. Paul, MN), announced CE Mark approval and the European launch of its Enlightn renal denervation system at the EuroPCR 2012 conference in Paris.

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