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bioresorbable implant

Pei-Jiang Wang, Farhad Rikhtegar Nezami, Maysam B Gorji, Francesca Berti, Lorenza Petrini, Tomasz Wierzbicki, Francesco Migliavacca, Elazer R Edelman
Polymeric bioresorbable scaffolds (BRS), at their early stages of invention, were considered as a promising revolution in interventional cardiology. However, they failed dramatically compared to metal stents showing substantially higher incidence of device failure and clinical events, especially thrombosis. One problem is that use of paradigms inherited from metal stents ignores dependency of polymer material properties on working environment and manufacturing/deployment steps. Unlike metals, polymeric material characterization experiments cannot be considered identical under dry and submerged conditions at varying rates of operation...
October 17, 2018: Acta Biomaterialia
Do Hyun Kim, Won-Soo Yun, Jin-Hyung Shim, Keun-Ho Park, Dami Choi, Moon Il Park, Se Hwan Hwang, Sung Won Kim
Importance: Studies have shown the controllability and porosity of polycaprolactone as well as the use of 3-dimensional (3-D) printing for nasal reconstruction in animal models. The utility of polycaprolactone with 3-D technology in nasal cartilaginous framework reconstruction in humans remains unknown. Objective: To investigate the safety and efficacy of 3-D printed, bioresorbable polycaprolactone nasal implants. Design, Setting, and Participants: This multicenter clinical trial comprised 20 patients with caudal septal deviations who underwent septoplasty, which used a 3-D printed polycaprolactone mesh, at 2 centers in South Korea...
September 20, 2018: JAMA Otolaryngology—Head & Neck Surgery
Martin Kozel, Viktor Kočka, Libor Lisa, Tomáš Buděšínský, Petr Toušek
A higher rate of bioresorbable vascular scaffold (BVS) thrombosis has been observed after device implantation compared to implantation of permanent metallic stents in recently published studies. The mechanism of BVS thrombosis is currently under debate. To assess whether the immune-inflammatory response after BVS implantation is a potential trigger of BVS thrombosis. The PRAGUE-19 study was an academic study that enrolled consecutive patients with ST-segment elevation myocardial infarction (STEMI) with the intention to implant a BVS...
October 12, 2018: Heart and Vessels
Alfonso Ielasi, Gianluca Campo, Bernardo Cortese, Massimo Leoncini, Attilio Varricchio, Salvatore Brugaletta, Enrico Favaretto, Massimo Fineschi, Davide Piraino, Paolo Calabria, Francesco Granata, Francesco Pisano, Marco Mussardo, Azeem Latib, Maurizio Tespili
BACKGROUND: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI)...
October 4, 2018: Cardiovascular Revascularization Medicine: Including Molecular Interventions
Geisa Salles, Michele Calio, Samson Afewerki, Cristina Pacheco-Soares, Marimelia Porcionatto, Christian Hölscher, Anderson Oliveira Lobo
Delivering drugs and agents to the brain consists in a huge challenge, especially for chronic neurodegenerative disorders, such as Alzheimer's disease (AD). For this, prolonged and sustained release methods to increase brain uptake represent an impacting concept. The bioresorbable polymer poly-lactic acid (PLA) has high potential for medical implants, at the same time, glucagon-like peptide-1 (GLP-1) analogues have considerable neuroprotective attributes and represent a therapeutic strategy for AD. Here, a biodevice is produced by electrospinning PLA with a GLP-1 analogue (liraglutide, LG), coated with a thin layer of gelatin...
October 9, 2018: ACS Applied Materials & Interfaces
Pawel Gasior, Marek Gierlotka, Krzysztof Szczurek-Katanski, Marcin Osuch, Roman Gnot, Michał Hawranek, Mariusz Gasior, Lech Polonski
OBJECTIVES: We sought to determine the 1-year clinical follow-up in patients treated with the thin strut (71 μm) bioabsorbable polymer-coated sirolimus-eluting stent (BP-SES) vs durable coating everolimus eluting stent (DP-EES) in daily clinical routine. BACKGROUND: Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety...
October 8, 2018: Catheterization and Cardiovascular Interventions
Satoru Mitomo, Akihito Tanaka, Luciano Candilio, Lorenzo Azzalini, Mauro Carlino, Azeem Latib, Antonio Colombo
A 55-year-old male underwent percutaneous coronary intervention (PCI) for left anterior descending artery chronic total occlusion. After lesion preparation with non-compliant (NC) balloon, two bioresorbable vascular scaffolds (2.5/28 mm, 3.0/28 mm, Absorb BVS, Abbott Vascular, Santa Clara, CA, USA) were implanted followed by 1:1 sized NC balloon post-dilatation at 20 atm. Final intravascular ultrasound (IVUS) showed acceptable BVS expansion in diffusely calcified lesions. Twenty-one months' follow-up coronary angiography revealed severe restenosis with reocclusion at the distal edge of the distal BVS...
April 2018: Journal of Cardiology Cases
Livia Luciana Gheorghe, Xavier Millán, Marcelo Jimenez-Kockar, Josep Gomez-Lara, Dabit Arzamendi, Leonardo Danduch, Victor Agudelo, Antonio Serra
AIMS: Percutaneous treatment of coronary chronic total occlusion (CTO) is associated with important arterial remodelling after successful recanalization. Bioresorbable vascular scaffold (BVS) implantation in CTO has been shown feasible and can be of interest when the scaffold achieves complete bioresorption. We sought to evaluate the 3-year results in terms of clinical events, serial imaging outcomes and the vasomotion response in CTO lesions successfully treated with BVS. METHODS AND RESULTS: A total of 33 patients (35 CTO lesions) successfully treated with BVS were included in ABSORB-CTO study...
October 2, 2018: EuroIntervention
Satoru Mitomo, Richard J Jabbour, Azeem Latib, Antonio Colombo
Bioresorbable vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, CA) temporarily elute antiproliferative drugs and provide vessel support, which then subsequently resorb to allow restoration of normal vessel function and architecture. To attain the best possible results with BVS, a dedicated implantation technique (PSP: adequate lesion preparation, proper sizing, postdilatation) is considered mandatory, and calcified lesions are one of the most challenging lesion subsets for BVS implantation. In five cases with severe calcifications refractory to balloon predilatation, we performed excimer laser catheter ablation (ELCA: Turbo Elite catheter; Spectranetics Corporation, Colorado Springs, CO, USA), which facilitated adequate lesion expansion with high-pressure noncompliant balloon inflation and BVS implantation...
September 30, 2018: Catheterization and Cardiovascular Interventions
Gregg W Stone, Stephen G Ellis, Tommaso Gori, D Christopher Metzger, Bernardo Stein, Matthew Erickson, Jan Torzewski, Jerome Williams, William Lawson, Thomas M Broderick, Ameer Kabour, Guy Piegari, Jeffrey Cavendish, Barry Bertolet, James W Choi, Steven O Marx, Philippe Généreux, Dean J Kereiakes
BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada)...
September 24, 2018: Lancet
Clemens von Birgelen, Paolo Zocca, Rosaly A Buiten, Gillian A J Jessurun, Carl E Schotborgh, Ariel Roguin, Peter W Danse, Edouard Benit, Adel Aminian, K Gert van Houwelingen, Rutger L Anthonio, Martin G Stoel, Samer Somi, Marc Hartmann, Gerard C M Linssen, Carine J M Doggen, Marlies M Kok
BACKGROUND: During the past decade, many patients had zotarolimus-eluting stents implanted, which had circular shape cobalt-chromium struts with limited radiographic visibility. The Resolute Onyx stent was developed to improve visibility while reducing strut thickness, which was achieved by using a novel composite wire with a dense platinum-iridium core and an outer cobalt-chromium layer. We did the first randomised clinical trial to assess the safety and efficacy of this often-used stent compared with the Orsiro stent, which consists of ultrathin cobalt-chromium struts...
September 21, 2018: Lancet
Manisha Singh, Himansu Sekhar Nanda, Richard D O'Rorke, Adam E Jakus, Ankur Harish Shah, Ramille N Shah, Richard D Webster, Terry W J Steele
Soft tissue fixation of implant and bioelectrodes relies on mechanical means (e.g., sutures, staples, and screws), with associated complications of tissue perforation, scarring, and interfacial stress concentrations. Adhesive bioelectrodes address these shortcomings with voltage cured carbene-based bioadhesives, locally energized through graphene interdigitated electrodes. Electrorheometry and adhesion structure activity relationships are explored with respect to voltage and electrolyte on bioelectrodes synthesized from graphene 3D-printed onto resorbable polyester substrates...
September 25, 2018: Advanced Healthcare Materials
Arif Al-Nooryani, Galal Alli Abdalla, Tharwat Abdul Ghafar, Amit Bhatia, Branko Beleslin
Bioresorbable vascular scaffolds (BVS) have been designed to overcome long-term limitations of metallic drug-eluting stents including permanent metallic "caging" that might trigger late coronary adverse events. Here, we report for the first time a case of 72-year gentleman with previous coronary artery disease, treated by successful implantation of BVS (Absorb, Abbott Vascular) due to significant stenosis of internal pudenda artery and erectile dysfunction. After 2 years, BVS completely resorbed and there were no signs of pudendal artery restenosis on CT scan, whereas blood flow and sexual function improved...
September 24, 2018: Andrologia
Artur Dziewierz, Dariusz Dudek
New-generation drug-eluting stents are recommended as the default option in all clinical conditions and lesion subsets in patients undergoing percutaneous coronary intervention (PCI). On the other hand, despite achieving very good results in the rate of restenosis, permanent delivery of a metallic platform is affected by several drawbacks, such as caging of the vessel, side branch jailing, impairment of vasomotion, and the impossibility of lumen enlargement. Also, the presence of residual foreign material may increase the risk of late and very late stent thrombosis and support the need for long-term dual antiplatelet therapy after PCI...
2018: Kardiologia Polska
Arif Al Nooryani, Wael N Elabbassi, Bassam AlBaba, Jalal A Kerfes, Loai M Abudaqa, Amit Bhatia, Nagwa A Abdelrahman, Nikola Boskovic, Branko Beleslin
Objectives To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population. Methods This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization. Results A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26-41 months]; complete follow-up, 201 patients)...
September 21, 2018: Journal of International Medical Research
M Janickova, D Statelova, K Mikuskova, M Jesenak, I Malachovsky
OBJECTIVE: The use of biodegradable materials represents a new option in the treatment of paediatric facial skeleton fractures. The benefits of a resorbable system include reductions in time for long-term stability, diminished immobilisation period, and elimination of painful procedures for implant removal. The resorption of the material did not influence bone repair and growth. Bioresorbable plates and screws get completely excreted through physiological routes. MATERIAL AND METHODS: The age of the patients ranges from that of pre-schoolers till 18 years...
2018: Bratislavské Lekárske Listy
Karthik Ramachandran, Tiziana Di Luccio, Artemis Ailianou, Mary Beth Kossuth, James P Oberhauser, Julia A Kornfield
Biodegradable polymers open the way to treatment of heart disease using transient implants (bioresorbable vascular scaffolds, BVSs) that overcome the most serious complication associated with permanent metal stents-late stent thrombosis. Here, we address the long-standing paradox that the clinically approved BVS maintains its radial strength even after 9 mo of hydrolysis, which induces a ∼40% decrease in the poly l-lactide molecular weight ( Mn ). X-ray microdiffraction evidence of nonuniform hydrolysis in the scaffold reveals that regions subjected to tensile stress during crimping develop a microstructure that provides strength and resists hydrolysis...
October 9, 2018: Proceedings of the National Academy of Sciences of the United States of America
Satoru Mitomo, Luciano Candilio, Akihito Tanaka, Azeem Latib, Antonio Colombo
No abstract text is available yet for this article.
2018: Cardiology Journal
Florian Blachutzik, Stephan Achenbach, Monique Tröbs, Mohamed Marwan, Melissa Weissner, Holger Nef, Christian Schlundt
BACKGROUND: Optimal implantation results of bioresorbable scaffolds (BRS) are typically assumed to require postdilatation with non-compliant (NC) balloons to achieve full scaffold apposition and minimize event rates. We systematically evaluated the mechanical effect of NC balloon postdilatation on magnesium-based BRS (Magmaris®, Biotronik AG, Bülach, Switzerland) in vivo. METHODS: In 35 patients, 40 Magmaris® BRS were implanted to treat 37 de novo coronary artery stenoses...
September 9, 2018: Catheterization and Cardiovascular Interventions
Salvatore Brugaletta, Angel Cequier, Fernando Alfonso, Andrés Iñiguez, Sebastian Romaní, Antonio Serra, Pablo Salinas, Javier Goicolea, Pascual Bordes, Bruno García Del Blanco, Rosana Hernández-Antolín, Alberto Pernigotti, Josep Gómez-Lara, Manel Sabaté
AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI...
September 9, 2018: Catheterization and Cardiovascular Interventions
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