Angiographic and Histopathological Characteristics of a Novel Polyacrylate Liquid Embolic Agent Compared with Ethylene-Vinyl Alcohol Copolymer in a Large Animal Model.

Purpose: To study the in vivo safety and effectiveness of a novel radiopaque nonadhesive polyacrylate (PA) peripheral liquid embolic system (AMBER SEL-P) relative to ethylene-vinyl alcohol copolymer (EVOH, Onyx) in a healthy swine endovascular model.

Materials And Methods: Twenty-five swine underwent rete mirabile and bilateral kidney embolization with PA or EVOH and were followed up for 24 hours (n = 5) and 30 days (n = 10), and 3 (n = 10) months. Angiographic features (penetrability, radiopacity, catheter entrapment, fragmentation, occlusion, and vasospasm) were evaluated.

Comparative evaluation of local and downstream responses in two commercially available paclitaxel-coated balloons in healthy peripheral arteries of a swine model.

Objective: To investigate the local, downstream, and systemic effects of 2 different paclitaxel-coated balloons.

Design: Preclinical study in healthy peripheral arteries of a swine model, with randomized allocation of the distribution of the devices: the test paclitaxel-coated balloon (PCB) (Luminor), a control PCB (IN.PACT), and a plain angioplasty balloon (Oceanus), considering single (1×) and overlapping (3×) doses with simple blind histologic analysis.

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model.

Introduction And Objectives: New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries.

Methods: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs.

Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study.

Introduction And Objectives: Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries.

Methods: Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs.

Safety and efficacy of different paclitaxel-eluting balloons in a porcine model.

Introduction And Objectives: Paclitaxel-eluting balloons have shown high antiproliferative efficacy in the treatment and prevention of restenosis. Nevertheless, not all available devices are equally effective, which makes it interesting to compare results in a preclinical model. Our objective was to assess the preclinical efficacy and safety of different devices.