The EluNIRTM Ridaforolimus Eluting Coronary Stent System.

Abstract:

INTRODUCTION:First-generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, more biocompatible and either durable, biodegradable or polymer-free surfaces, better device profile and refined drug elution. Area covered: The EluNIRTM (Medinol, Tel Aviv, Israel) Ridaforolimus Eluting Coronary Stent System is a new DES with unique properties. In this review, we highlight the special characteristics of the stent and summarize relevant clinical data. The EluNIRTM was studied in two clinical trials, the NIREUS trial and the larger, pivotal, BIONICS trial. These trials collectively provide data on the safety, performance, and efficacy of the device. Expert commentary: The newly FDA-approved EluNIRTM stent features an elastomeric durable polymer which elutes a novel drug, Ridaforolimus. The stent has thin struts with variable widths and a delivery catheter with a spring tip. These characteristics may explain the good angiographic and clinical results of this stent, which were noninferior to the FDA-approved Medtronic ResoluteTM stent DES.

journal_name

Expert Rev Med Devices

authors

Savvoulidis P,Perlman G,Bagur R

doi

10.1080/17434440.2018.1549986

subject

Has Abstract

pub_date

2019-01-01 00:00:00

pages

71-76

issue

1

eissn

1743-4440

issn

1745-2422

journal_volume

16

pub_type

杂志文章
  • New autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis.

    abstract::Methotrexate (MTX) is the cornerstone of treatment for rheumatoid arthritis (RA), and is widely used both as first-line therapy and as an important component of long-term therapy. Although subcutaneous MTX is typically delivered orally, parenteral administration offers benefits with respect to tolerability and systemi...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2014.929492

    authors: Schiff M,Jaffe J,Freundlich B,Madsen P

    更新日期:2014-09-01 00:00:00

  • Current interventional coronary applications of excimer laser.

    abstract::Excimer laser utilization as an adjunctive device for percutaneous coronary intervention has increased in the last few years. Many technical advancements have led to better results in terms of efficacy and safety with a low complication rate. In particular, excimer laser for thrombus-containing lesions is able to achi...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2013.811846

    authors: Fracassi F,Roberto M,Niccoli G

    更新日期:2013-07-01 00:00:00

  • Cardiac rhythm management devices in a magnetic resonance environment.

    abstract::MRI is the gold standard diagnostic tool for soft tissue imaging for many specialties. An impressive body of research has proven the effectiveness of cardiac rhythm management devices (CRMDs) objectively, in terms of parameters that include patient's quality of life, morbidity, and mortality. However, interaction betw...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2014.882228

    authors: Fanourgiakis J,Kanoupakis E

    更新日期:2014-03-01 00:00:00

  • The Visible Heart® project and methodologies: novel use for studying cardiac monophasic action potentials and evaluating their underlying mechanisms.

    abstract:INTRODUCTION:This review describes the utilization of Visible Heart® methodologies for electrophysiologic studies, specifically in the investigation of monophasic action potential (MAP) recordings, with the aim to facilitate new catheter/device design and development that may lead to earlier diagnosis, treatment, and u...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2018.1493922

    authors: Schmidt MM,Iaizzo PA

    更新日期:2018-07-01 00:00:00

  • Patient-specific instrumentation in total knee arthroplasty.

    abstract:INTRODUCTION:Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic procedures. During the past decade, patient-specific instrumentation (PSI) has been commercially introduced in order to simplify and make TKA surgery more effective, precise and efficient than conventional mechanical instrumenta...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2019.1627197

    authors: León-Muñoz VJ,Martínez-Martínez F,López-López M,Santonja-Medina F

    更新日期:2019-07-01 00:00:00

  • Update on the management and associated challenges of adult patients treated with veno-arterial extracorporeal membrane oxygenation.

    abstract:INTRODUCTION:Currently, veno-arterial extracorporeal membrane oxygenation (VA ECMO) represents a valuable treatment option for patients presenting with severe cardiogenic shock. Although the overall usage of VA ECMO in experienced centers is expanding, some management aspects remain challenging, with no consensus among...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2019.1614439

    authors: Kado Y,Miyamoto T,Fukamachi K,Karimov JH

    更新日期:2019-06-01 00:00:00

  • Non-invasive assessment of gestational hemodynamics: benefits and limitations of impedance cardiography versus other techniques.

    abstract::To obtain data for maternal stroke volume and cardiac output during pregnancy, it is preferable to use a non-invasive, accurate and reproducible method. In this aspect, impedance cardiography is an excellent technique which is also highly accessible and easy to perform. This paper is a comprehensive review on the publ...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2013.853466

    authors: Staelens A,Tomsin K,Grieten L,Oben J,Mesens T,Spaanderman M,Jacquemyn Y,Gyselaers W

    更新日期:2013-11-01 00:00:00

  • Evolution of endovascular stroke therapies and devices.

    abstract::Acute ischemic stroke is caused by occlusion of a cerebral artery, resulting in loss of brain tissue and neurologic deficits. However, a portion of the ischemic brain can be salvaged if blood flow is restored within an appropriate time frame. The past year has seen the publication of five positive randomized controlle...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2016.1143772

    authors: Wallace AN,Kansagra AP,McEachern J,Moran CJ,Cross DT 3rd,Derdeyn CP

    更新日期:2016-01-01 00:00:00

  • Miniaturization of left ventricular assist devices: the ongoing trend.

    abstract::The shortage of appropriate donor hearts and the expanding pool of patients waiting for a heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. With expanding clinical experience and continued technical advances, continuous-flow pumps are evolving...

    journal_title:Expert review of medical devices

    pub_type: 历史文章,杂志文章,评审

    doi:10.1586/erd.11.62

    authors: Garbade J,Bittner HB,Lehmann S,Mohr FW,Barten MJ

    更新日期:2012-01-01 00:00:00

  • Stent placement for esophageal strictures: an update.

    abstract::The use of stents for esophageal strictures has evolved rapidly over the past 10 years, from rigid plastic tubes to flexible self-expanding metal (SEMS), plastic (SEPS) and biodegradable stents. For the palliative treatment of malignant dysphagia both SEMS and SEPS effectively provide a rapid relief of dysphagia. SEMS...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/erd.11.44

    authors: Hirdes MM,Vleggaar FP,Siersema PD

    更新日期:2011-11-01 00:00:00

  • Non-invasive imaging techniques to assess myocardial perfusion.

    abstract:INTRODUCTION:Coronary artery disease affecting myocardial perfusion continues to be the leading cause of cardiovascular morbidity and mortality worldwide. While invasive evaluation based on coronary angiography and flow measurements still is considered the reference technique for assessing myocardial perfusion, technol...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2020.1834844

    authors: Villemain O,Baranger J,Jalal Z,Lam C,Calais J,Pernot M,Cifra B,Friedberg MK,Mertens L

    更新日期:2020-11-01 00:00:00

  • Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings.

    abstract:BACKGROUND:With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections us...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章

    doi:10.1080/17434440.2018.1421942

    authors: Lu H,Kalkman DN,Grundeken MJ,Tijssen JGP,Wykrzykowska JJ,de Winter RJ,Koch KT

    更新日期:2018-02-01 00:00:00

  • Single-step atrial thrombus exclusion and transesophageal cardioversion in atrial fibrillation.

    abstract::Atrial fibrillation (AF), the most common arrhythmia, has a major impact on both patient morbidity and healthcare economics. Hospital admissions due to AF have risen by two-thirds in the last 20 years. This is due mainly to an aging population and an increasing prevalence of chronic heart disease. Strategies for the m...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.4.4.549

    authors: Mischke K,Schimpf T,Knackstedt C,Hanrath P,Schauerte P

    更新日期:2007-07-01 00:00:00

  • Drug-eluting stents: from evidence to policy.

    abstract::Drug-eluting stents are a major breakthrough in cardiology, with the Cypher (Cordis Corporation) and Taxus (Boston Scientific) stents preventing 60-70% of repeat coronary revascularizations, compared with bare metal stents. Both evidence- and risk-based application of drug-eluting stents is expected to create relevant...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.1.1.49

    authors: Marchetti M

    更新日期:2004-09-01 00:00:00

  • Evaluation of Pipeline Flex delivery system for the treatment of unruptured aneurysms.

    abstract:INTRODUCTION:Refinements in endovascular technology have revolutionized the treatment of intracranial aneurysms (IAs) with the development of flow-diversion technology. The first generation of the Pipelin Embolization Device (PED) has demonstrated its safety and efficacy. However, the deployment technique was a difficu...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章

    doi:10.1080/17434440.2016.1231573

    authors: Aguilar-Salinas P,Brasiliense LB,Gonsales D,Mitchell B,Lima A,Sauvageau E,Hanel R

    更新日期:2016-10-01 00:00:00

  • New developments in the delivery of cardiac resynchronization therapy: targeted lead placement, multi-site and endocardial pacing.

    abstract::Cardiac resynchronization therapy (CRT) is a proven treatment adjunct for selected patients with heart failure and evidence of ventricular dyssynchrony. When applying most contemporary guidelines the accepted response rate has remained static with up to one-third of patients failing to respond. Empiric lateral/postero...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2014.885320

    authors: Sohal M,Chen Z,Sammut E,Jackson T,Behar J,Carr-White G,Razavi R,Rinaldi CA

    更新日期:2014-05-01 00:00:00

  • Plugs for left atrial appendage occlusion: an overview of available devices.

    abstract:INTRODUCTION:Approximately one-third of all ischemic strokes and the ensuing health and economic burden can be attributed to the presence of atrial fibrillation (AF). The global prevalence of AF continues to rise, thus making it by far the most common diagnosed cardiac arrhythmia. Percutaneous left atrial appendage (LA...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2020.1837621

    authors: Obeid S,Nietlispach F,Meier B

    更新日期:2020-11-01 00:00:00

  • Robotic navigation during spine surgery.

    abstract::Introduction: Potential complications associated with screw malposition may result in neurological deficits or vascular injuries. Spine surgery has significantly developed under the assistance of technological progress. The advantages of applying robotic technology in spine surgery include the possibility of improving...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2020.1699405

    authors: Zhang Q,Han XG,Xu YF,Fan MX,Zhao JW,Liu YJ,He D,Tian W

    更新日期:2020-01-01 00:00:00

  • Crux vena cava filter.

    abstract::Inferior vena cava filters are widely accepted for pulmonary embolic prophylaxis in high-risk patients with contraindications to anticoagulation. While long-term complications have been associated with permanent filters, retrievable filters are now available and have resulted in the rapid expansion of this technology....

    journal_title:Expert review of medical devices

    pub_type: 杂志文章

    doi:10.1586/erd.09.25

    authors: Murphy EH,Johnson ED,Kopchok GE,Fogarty TJ,Arko FR

    更新日期:2009-09-01 00:00:00

  • Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.

    abstract::The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction betwee...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/erd.12.5

    authors: Mattei E,Censi F,Triventi M,Bartolini P,Calcagnini G

    更新日期:2012-05-01 00:00:00

  • Advances in temporary mechanical support for treatment of cardiogenic shock.

    abstract::Mechanical circulatory support devices are the mainstay of treatment for severe cardiogenic shock refractory to pharmacologic therapy. Their evolution over the past few decades has been remarkable with a common theme of developing reliable, less bulky and more easily percutaneously implantable devices. The goal of thi...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2015.1086265

    authors: Koprivanac M,Kelava M,Soltesz E,Smedira N,Kapadia S,Brzezinski A,Alansari S,Moazami N

    更新日期:2015-01-01 00:00:00

  • Using haptic stimulation to enhance auditory perception in hearing-impaired listeners.

    abstract:INTRODUCTION:Hearing-assistive devices, such as hearing aids and cochlear implants, transform the lives of hearing-impaired people. However, users often struggle to locate and segregate sounds. This leads to impaired threat detection and an inability to understand speech in noisy environments. Recent evidence suggests ...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章

    doi:10.1080/17434440.2021.1863782

    authors: Fletcher MD

    更新日期:2020-12-29 00:00:00

  • Clinical role of fluorescence imaging in colorectal surgery - a review.

    abstract:INTRODUCTION:Anastomotic leak (AL) after colorectal surgery is a devastating complication; decreased blood perfusion is an important risk factor. Surgeons rely on subjective measures to assess bowel perfusion. Fluorescence imaging (FI) with indocyanine green (ICG) provides a real-time objective assessment of intestinal...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,meta分析,评审

    doi:10.1080/17434440.2017.1265444

    authors: Mizrahi I,Wexner SD

    更新日期:2017-01-01 00:00:00

  • Wearable sensors to improve detection of patient deterioration.

    abstract:INTRODUCTION:Monitoring a patient's vital signs forms a basic component of care, enabling the identification of deteriorating patients and increasing the likelihood of improving patient outcomes. Several paper-based track and trigger warning scores have been developed to allow clinical evaluation of a patient and guida...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2019.1563480

    authors: Joshi M,Ashrafian H,Aufegger L,Khan S,Arora S,Cooke G,Darzi A

    更新日期:2019-02-01 00:00:00

  • Bicomponent electrospun scaffolds to design extracellular matrix tissue analogs.

    abstract::In the last decade, bicomponent fibers have been proposed to fabricate bio-inspired systems for tissue repair, regenerative medicine, medical healthcare and clinical applications. In comparison with monocomponent fibers, key advantage concerns their ability of self-adapting to the physiological conditions through an e...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.2016.1126505

    authors: Guarino V,Cirillo V,Ambrosio L

    更新日期:2016-01-01 00:00:00

  • Shields and garb for decreasing radiation exposure in the cath lab.

    abstract:INTRODUCTION:Decreasing radiation exposure of the cardiac catheterization laboratory staff is critical for minimizing radiation-related adverse outcomes and can be accomplished by decreasing patient dose and by shielding. Areas covered: protection from ionizing radiation can be achieved with architectural, equipment-mo...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2018.1510771

    authors: Karatasakis A,Brilakis ES

    更新日期:2018-09-01 00:00:00

  • Hemodialysis machine technology: a global overview.

    abstract::The market for hemodialysis machines, the background, the current products of manufacturers and the features of hemodialysis machines are described in this article. In addition to the established companies and their products, Chinese manufacturers, and new developments for home hemodialysis, are outlined based on publ...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/erd.10.54

    authors: Polaschegg HD

    更新日期:2010-11-01 00:00:00

  • Designing medical technology for resilience: integrating health economics and human factors approaches.

    abstract:INTRODUCTION:The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthca...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章

    doi:10.1080/17434440.2018.1418661

    authors: Borsci S,Uchegbu I,Buckle P,Ni Z,Walne S,Hanna GB

    更新日期:2018-01-01 00:00:00

  • Shortening hospital stay for thyroid surgery.

    abstract::The number of outpatient surgical procedures performed in hospitals, increases daily. In some countries, such as Italy, outpatient operations outnumber inpatient operations. The incidence of thyroid disorders and, in particular, the cancer forms, has been increasing sharply for many years in several countries. Even if...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1586/17434440.5.1.85

    authors: Dionigi G,Bacuzzi A,Rovera F,Boni L,Piantanida E,Tanda ML,Castano P,Annoni M,Bartalena L,Dionigi R

    更新日期:2008-01-01 00:00:00

  • Insertable cardiac monitors: current indications and devices.

    abstract:INTRODUCTION:Recurrent unexplained syncope is a well-established indication for an insertable cardiac monitor (ICM). Recently, the indications for an ICM have been expanded. AREAS COVERED:This review article discusses the current indications for ICMs and gives an overview of the latest generation of commercially avail...

    journal_title:Expert review of medical devices

    pub_type: 杂志文章,评审

    doi:10.1080/17434440.2018.1557046

    authors: Sakhi R,Theuns DAMJ,Szili-Torok T,Yap SC

    更新日期:2019-01-01 00:00:00