30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.
Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.

开始日期2026-12-31

申办/合作机构

Vascular Graft Solutions Ltd.

NCT05914246 / Active, not recruitingN/A

VIOLA PMS Clinical Protocol

The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

开始日期2023-07-05

申办/合作机构

Vascular Graft Solutions Ltd.

NCT03209609 / Active, not recruitingN/A

A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support

Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.

开始日期2018-01-09

申办/合作机构

Vascular Graft Solutions Ltd.

100 项与 Vascular Graft Solutions Ltd. 相关的临床结果

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0 项与 Vascular Graft Solutions Ltd. 相关的专利（医药）

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项与 Vascular Graft Solutions Ltd. 相关的文献（医药）

2022-08-01·JAMA cardiology

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Article

作者: Marks, Mary E. ; Taylor, Bradley S. ; Voisine, Pierre ; Scavo, Vincent ; DiMaio, J. Michael ; Dagenais, François ; Bagiella, Emilia ; Puskas, John D. ; Yarden, Orit ; Orion, Eyal ; Mack, Michael J. ; Williams, Judson B. ; Gillinov, Marc ; Gammie, James S. ; Moquete, Ellen G. ; Jessup, Mariell ; Ailawadi, Gorav ; Raymond, Samantha ; Acker, Michael A. ; O’Gara, Patrick T. ; Goldstein, Daniel J. ; Chu, Michael W. A. ; Crestanello, Juan A. ; Gelijns, Annetine C. ; Iribarne, Alexander ; Moskowitz, Alan J. ; Vengrenyuk, Yuliya ; Chang, Helena L. ; O’Sullivan, Karen ; Narula, Jagat ; Rose, Eric A. ; Alexander, John H.

Importance:

Intimal hyperplasia and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.

Objective:

To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure.

Design, Setting, and Participants:

This within-patient randomized, open-label, multicenter study was conducted at 17 Cardiothoracic Surgical Trials Network centers in North America. Between January 2018 and February 2019, 224 patients with multivessel coronary artery disease undergoing isolated bypass surgery were enrolled. For each patient, 1 of 2 vein grafts was randomized to receive external support or no support.

Interventions:

External vein graft support or no support.

Main Outcomes and Measures:

The primary efficacy end point was intimal hyperplasia area assessed by intravascular ultrasound at 12 months postrandomization for each study graft. Secondary confirmatory end points were lumen diameter uniformity assessed by angiography and graft failure (≥50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.

Results:

Among 224 patients (mean [SD] age, 65.8 [8.3] years; 178 [79.5%] male), 203 (90.6%) were eligible for intravascular ultrasound, of which 85 (41.9%) had at least 1 study graft occluded or severely diseased at 12 months (55 supported, 56 unsupported). After imputation of data missing because of graft occlusion or severe disease, the estimated mean (SE) intimal hyperplasia area was 5.11 (0.16) mm2 in supported grafts and 5.79 (0.20) mm2 in unsupported grafts (P = .07). In a sensitivity analysis of 113 patients with both grafts imaged, the mean intimal hyperplasia area was 4.58 (0.18) mm2 and 5.12 (0.23) mm2 in supported and unsupported grafts, respectively (P = .04). By 12 months, 5 patients (2.2%) died and 16 patients (7.1%) experienced a major cardiac or cerebrovascular event.

Conclusions and Relevance:

The 12-month difference in intimal hyperplasia area between supported and unsupported grafts did not achieve statistical significance. Cumulative mortality and major cardiac or cerebrovascular events rates were similar to those in other randomized coronary artery bypass trials. Further investigation to assess the effect of external graft support devices on long-term graft patency and clinical outcomes is warranted.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03209609.

2015-11-01·The Annals of thoracic surgery

Letter

作者: Orion, Eyal ; Taggart, David P

2015-10-01·The Journal of thoracic and cardiovascular surgery1区 · 医学

Flow patterns in externally stented saphenous vein grafts and development of intimal hyperplasia

1区 · 医学

Article

作者: Meirson, Tomer ; Orion, Eyal ; Ben Gal, Yanai ; Di Mario, Carlo ; Channon, Keith M ; Taggart, David P ; Patel, Niket ; Webb, Carolyn

BACKGROUND:

Low and oscillatory wall shear stress promotes endothelial dysfunction and vascular disease. The aim of the study was to investigate the impact of an external stent on hemodynamic flow parameters in saphenous vein grafts (SVGs) and their correlation with the development of intimal hyperplasia.

METHODS:

We performed post hoc computational fluid dynamics analysis of the randomized Venous External Support Trial, in which angiography and intravascular ultrasound data were available for 29 patients, 1 year after coronary artery bypass grafting. Each patient received 1 external stent, to either the right or left coronary territories; ≥ 1 patients with nonstented SVGs served as control(s). Diffuse flow patterns were assessed using mean values of various hemodynamic parameters, including time-averaged wall shear stress and oscillatory shear index (OSI). Focal flow disturbances were characterized using percentile analysis of each parameter.

RESULTS:

Angiography and intravascular ultrasound data were available for 53 and 43 SVGs, respectively. The stented versus nonstented SVG failure rates were significantly lower in the left territory (17.6% vs 27.5%; P = .02), and significantly higher in the right territory (46.2% vs 13.4%; P = .01). In both diffuse and focal flow-pattern analyses, OSI was significantly lower in the stented versus nonstented SVG group (P = .009 and P < .003, respectively), whereas no significant differences were observed in time-averaged wall shear stress values. High OSI values were correlated with the development of intimal hyperplasia (P = .01).

CONCLUSIONS:

External stenting affects SVG's hemodynamics 1 year after coronary artery bypass grafting and may mitigate the progression of intimal hyperplasia by reducing oscillatory shear stress.

项与 Vascular Graft Solutions Ltd. 相关的新闻（医药）

2024-10-16

·PRNewswire

CardioSight, Inc. Appoints New CEO

BUDAPEST, Hungary, Oct. 15, 2024 /PRNewswire/ -- CardioSight, Inc., developers of a revolutionary intra-cardiac visualization and interventional platform, announces the appointment of Steve Motes as Chief Executive Officer effective October 15, 2024. Continue Reading Steve Motes, CEO Steve brings to CardioSight more than 25 years of medical device industry experience. He most recently served as the CEO of Vascular Graft Solutions, a Tel Aviv, Israel startup. Before VGS, Steve served as the U.S. Vice President of Acute MCS/ECMO at Abbott (formerly St. Jude/Thoratec). He began his career at Abbott as a Director of Mechanical Circulatory Support. Steve also had successful careers at Edwards Lifesciences, Medtronic (formerly Covidien/Somanetics), and Dräger Medical. "Steve's broad background of medical device sales leadership, launching new products, commercializing acquired technologies, and his experience in running startup organizations while fundraising makes him the right leader at the right time for CardioSight" - Attila Meretei, CEO, MedRes and CardioSight Board Member. "We are thrilled to have Steve lead the team here at CardioSight," said Dr. Pedro Del Nido, Member of the Board for CardioSight, Inc. "Steve's many years as a market leader in cardiac devices, coupled with his most recent executive experience, aligns well with CardioSight as we look to navigate the next phase of our company. With Steve on board, we can begin taking those next critical steps towards regulatory approval and commercialization". "Prototype development at CardioSight has advanced to a stage where we needed a commercially oriented leader who can transform a working technology into a product that will equip surgeons with new capability to image the work field and guide procedures to faster and better outcomes. Steve is that talented leader." - Carl Berke, PhD, Partner, Mass General Brigham Ventures and CardioSight Board Member. About CardioSight, Inc CardioSight is an emerging MedTech company aimed at providing surgeons and interventional cardiologists with a novel, first-of-its-kind, intra-cardiac visualization and interventional platform. It is designed to provide high-resolution near-field visualization to guide surgical instruments delivered through its working channel into the beating heart. It is intended to allow direct visualization of target cardiac tissues and instrument/tissue interaction and open the way to developing novel minimally invasive procedures. Media Contact Steve Motes [email protected] SOURCE CardioSight, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更

2023-04-25

·美通社

Cynosure任命Nadav Tomer为首席执行官

医学美容和技术领域领先企业 Cynosure 任命 Nadav Tomer 为首席执行官资深医疗技术高管将推进 Cynos3ure 的增长和创新战略，并巩固公司作为医疗美容技术领先机构的地位马萨诸塞州韦斯特福德 2023年4月25日 /美通社/ -- 医疗美学系统和技术领域领先企业Cynosure, LLC（以下称"Cynosure"或"公司"）今天宣布任命Nadav Tomer为Cynosure首席执行官。Tomer是一位成就卓著的医疗技术高管，也是Cynosure投资方Clayton, Dubilier & Rice（"CD&R"）旗下基金的前运营顾问。此项任命自2023年5月1日起生效。他将接替Todd Tillemans。Todd将辞去首席执行官一职，并将和 Tomer先生密切合作以确保平稳过渡。 Cynosure董事会主席Sandi Peterson表示："Nadav在医疗技术领域有着极其出色的运营执行往绩，我们很高兴欢迎他加入Cynosure，担任首席执行官。Nadav拥有数十年的从业经验，通过推进创新、加速全球商业化以及与研发团队合作以充分发挥其潜力，帮助全球医疗技术企业实现强劲、盈利的增长。对于我们利用Cynosure的优秀团队、全球基础设施和差异化技术的优势继续加强公司竞争优势而言，他的经验将是非常宝贵的。我相信Nadav是带领Cynosure实现下一阶段发展的正确领导人选。" Tomer表示："我很高兴能在医疗美容行业如此重要的转折点加入Cynosure。我关注Cynosure已经有一段时间，这家公司的创新产品、对客户的价值主张和世界一流团队给我留下了深刻印象。这些优势中的每一项对于长期成功都至关重要，并将帮助公司扩大其全球平台的影响力和绩效。最重要的是，我期待加入这家以使命为导向的公司。这家公司正在重新定义医学美容技术如何让所服务的患者感受到最佳状态。" Peterson继续说道："我谨代表整个董事会，感谢Todd在过去三年中的领导。他对奠定Cynosure当前业务的坚实基础发挥了不可或缺的作用，我们对他的贡献表示感谢。我们祝愿Todd在未来的事业中一切顺利。" 关于 Nadav Tomer Nadav Tomer为Cynosure带来了超过22年的高度相关的领导经验，曾为许多全球医疗技术企业监督全球损益并领导增长、转型和重振计划。他曾为强生公司的多项全球业务担任高级领导职务，包括专注于糖尿病护理、脊柱、心脏病、血管、骨科和电生理学等治疗领域的业务。最近期任职于强生公司期间， Tomer先生担任该公司价值14亿美元的DePuy Synthes Spine特许经营企业全球总裁（这是世界上最全面的脊柱医疗产品组合之一），并推动全球战略、商业执行、创新和组合及品牌管理举措，使该企业从以前的市场份额损失中稳定下来，并将产品研发管线价值提高两倍，从而使业务走上增长轨道。自2022年5月以来，Tomer先生一直担任Cynosure的主要投资者CD&R旗下基金的运营顾问，负责支持投资募集和为基金的医疗保健业务提供咨询。他还是Revival Healthcare Capital的运营合伙人，这是一家专注于医疗设备和诊断领域的投资公司。 Tomer先生目前担任Augmedics和Vascular Graft Solutions董事。他毕业于哈佛商学院的高级管理课程，拥有内盖夫本古里安大学的医学学士学位，以及巴伊兰大学金融和新创企业工商管理硕士学位。关于 Cynosure Cynosure拥有超过30年的以科学为驱动力的创新历史，是医疗美容治疗系统的领先供应商，使皮肤科医生、整形外科医生、医学水疗中心和其他医疗从业人员能够进行非侵入性和微创手术。公司广泛的产品组合涵盖多个主要类别，包括皮肤再生、身体塑形和脱毛。通过在美国、加拿大、法国、摩洛哥、德国、西班牙、英国、澳大利亚、中国、日本和韩国的直销人员，以及在大约130个其他国家\/地区的国际分销商，Cynosure在全球范围内销售其产品。如需企业或产品信息，请访问Cynosure网站： www.cynosure.com。

高管变更

2022-11-25

·PRNewswire

Vascular Grafts Market to Reach the Value of US$ 3.7 Bn by 2031, TMR Study

Increasing incidence of cardiovascular disorders and chronic kidney disorders among the expanding geriatric population underscores growth Characteristic of non-invasive surgical procedure, endovascular stent graft accounted for leading share in 2021 WILMINGTON, Del., Nov. 25, 2022 /PRNewswire/ -- The vascular grafts market size is estimated to rise at a CAGR of 5.6% over 2022 to 2031. The rising utilization of technologically advanced vascular graft products can be ascribed to the rising pool of geriatric individuals, who are more susceptible to cardiovascular illnesses. Apart from this, other essential market drivers include increase in the prevalence of various lifestyle related diseases, and growing healthcare expenditure around the world. Moreover, improvement in medical care and technological advancements in healthcare facilities in developing and developed economies are also aiding in the market development. Vascular Grafts Market – Key Findings of the Report Growing Prevalence of Cardiovascular and Lifestyle Related Disorders: Increase in the incidence of different types of lifestyle related diseases, including high blood pressure or hypertension, obesity, and diabetes, is creating increased demand within the market. These conditions are caused by unhealthy lifestyles, eating habits, and lack of exercise. Thus increase in the incidence of lifestyle related disorders such as hypertension, one of the most common lifestyle related diseases in a number of developed economies, creates growing need for hospitalization. This trend leads to growth in the demand for advanced products from the vascular grafts market. Get Exclusive PDF Sample Copy of Dental Biomaterials Market – Vascular Grafts Market – Growth Drivers Rising incidence of cardiovascular disorders propels demand for coronary artery bypass products Increasing demand for effective and non-invasive surgical procedures drives market growth Rise in the number of lifestyle related diseases augments the demand in the vascular graft market Vascular Grafts Market – Key Players Competitive landscape of the market is consolidated in nature. This can be ascribed to the presence of a relatively smaller number of leading players operating in the market. Some of the key vascular grafts companies operating in the global market include Becton, Dickinson and Company, Cryolife, Inc., Heart Medical, LeMaitre Vascular, Inc., Vascular Graft Solutions, B. Braun SE, Cook Medical, Inc., W. L. Gore & Associates, Inc., Gentinge AB, Junken Medical Co., Ltd., and Medtronic. Leading vascular grafts manufacturers in the market are focused on adopting various strategies, such as mergers and acquisitions, and product portfolio expansions, to gain a competitive edge over their competitors. Ask for References – Vascular Grafts Market: Regional Growth Assessment In 2021, the North America region accounted for the largest vascular grafts market share. In North America, the United States emerged as the leading country. Rising demand from the United States can be attributed to increasing prevalence of heart disorders and growth in the number of patients in the country. For instance, a study by the United States Centers for Disease Control and Prevention states that approximately one individual dies from cardiovascular diseases every 34 seconds in the nation. It also states that one in every five deaths in the United States is caused by cardiovascular diseases. Furthermore, increasing developments in the clinical trials being conducted in the United States is also positively influencing growth of the North America market. On the other hand, Asia Pacific is expected to display fastest growth in the vascular grafts market in the coming years. Growing demand from Asia Pacific can be attributed to rising number of deaths caused by cardiovascular diseases (CVD) in countries, such as Indonesia, China, Russia, and India. China dominated the demand within the Asia Pacific market, owing to the high number of deaths caused by CVDs. Apart from this, development of Asia Pacific market is also estimated to be driven by the increasing number of campaigns and programs aimed at spreading awareness regarding vascular graft procedures. This trend is creating an increased demand for products from surgeons in the region. Make an Enquiry Before Buying – Vascular Grafts Market: Segmentation Vascular Grafts Market, by Product Endovascular Stent Graft Peripheral Vascular Graft Hemodialysis Access Graft Bypass Graft Others Vascular Grafts Market, by Source Synthetic Polytetrafluethylene (PTFE) Polyurethane (PU) Dacron Others Biological Bovine Vein Saphenous Vein Others Biosynthetic Ovine Collagen with Polyester Others Vascular Grafts Market, by Size of Vascular Graft Large Size Vascular Graft Small Size Vascular Graft Vascular Grafts Market, by Application Coronary Artery Bypass Aneurysm Vascular Occlusion Critical Limb Ischemia Renal Failure Others Vascular Grafts Market, by End-user Hospitals Ambulatory Surgery Centers Cardiac Catheterization Laboratories Specialty Clinics Others Vascular Grafts Market, by Region North America Latin America Europe Asia Pacific Middle East & Africa Modernization of healthcare in terms of both infrastructure and services have pushed the healthcare industry to new heights, Stay Updated with Latest Healthcare Research Reports by Transparency Market Research: Continuous Renal Replacement Therapy Market: Continuous Renal Replacement Therapy Market is projected to grow at a CAGR of 7.5% from 2022 to 2031 and reach more than US$ 2.5 Bn by the end of 2031. 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Single-use Flexible Endoscope Market: Single-use Flexible Endoscope Market is projected to advance at a CAGR of 23.9% between 2022 and 2031 and reach more than US$ 9.1 Bn by the end of 2031. Nurse Call Systems Market: The global nurse call systems market is anticipated to reach more than US$ 4.2 Bn by the end of 2031 at a CAGR of 9.8% from 2022 to 2031. About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. For More Research Insights on Leading Industries, Visit Our YouTube Channel and hit subscribe for Future Update - Contact Nikhil Sawlani Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Blog: Email: [email protected] Logo: SOURCE Transparency Market Research

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