MassDevice EuroPCR 2018 Roundup

Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follow patients through to five years in a real-world setting after their treatment with the Portico, Abbott said. “Patients with severe aortic stenosis require timely treatment to reduce symptoms and improve clinical outcomes and quality of life. These new data reinforce that treatment with the Portico valve is safe in a real-world setting – with robust clinical results – and confirm that Portico is an excellent solution for patients at increased risk for surgery,” principal investigator Dr. Francesco Maisano of Zürich, Switzerland’s Universitäts Spital said in a prepared statement. A total of 941 patients have been treated so far in the trial at 61 centers across the EU, Canada and Australia. At 30 days post-implant, patients showed “excellent hemodynamic performance” of 8.6 mm Hg and an effective orifice area of 1.8 cm2. A total...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news