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New drug eluting stent system offers delivery benefits |
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| Stents
: 04 January, 2013 |
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Abbott's XIENCE Xpedition Everolimus Eluting Coronary Stent System receives US Food and Drug Administration (FDA) approval and is launching immediately in the USA, providing physicians with a next-generation technology that claims to offer the largest size matrix in the US market. |
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First patient enrolls in multicentre study of the SYNERGY coronary stent system |
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| Stents
: 03 December, 2012 |
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The first patient enrolls in the Boston Scientific EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the SYNERGY Stent System and support US Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. |
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MAQUET joins Stent For Life Initiative |
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| Stents
: 30 October, 2012 |
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MAQUET is joining the Stent for Life initiative as an industry partner to support a coalition of leading organizations, including the European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Society of Cardiology's Working Group on Acute Cardiac Care, and EuroPCR.
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STENTYS receives FDA approval to begin first US clinical trial with self-apposing stent |
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| Stents
: 24 October, 2012 |
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STENTYS receives Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to conduct a pivotal clinical trial in the USA which, if successfully completed, will enable the company to apply for marketing approval of the STENTYS Self-Apposing stent which the company claims is the world's first and only Self-Apposing stent to treat acute myocardial infarction (AMI). |
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Zilver PTX stent trial shows sustained patency after three years |
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| Stents
: 15 October, 2012 |
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Cook Medical reports that three-year data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease demonstrates 70.7 percent primary patency in the superficial femoral artery (SFA) at 36 months for patients treated with the paclitaxel-eluting stent. |
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Trial data shows stent delivers higher freedom from Target Lesion Revascularization rates |
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| Stents
: 14 August, 2012 |
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Three-year data from the Zilver PTX Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease indicates that Cook Medical's paclitaxel-eluting peripheral vascular stent demonstrated 83.0 percent freedom from TLR at 36 months in the PTX group, compared to 70.2 percent for patients treated with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study. |
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Boston Scientific launches Innova self-expanding bare-metal stent in Europe |
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| Stents
: 17 May, 2012 |
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Boston Scientific receives the CE Mark for the company's the Innova Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). |
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Abbott receives approval for XIENCE PRIME stent in Japan |
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| Stents
: 10 April, 2012 |
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Abbott receives approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the next-generation XIENCE PRIME Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. |
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Clinical trials spotlight QCA outcomes |
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| Stents
: 27 March, 2012 |
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Boston Scientific reveals results from a quantitative coronary angiographic (QCA) analysis of the incidence of longitudinal stent deformation in the PERSEUS and PLATINUM randomized clinical trials, comprising more than 2,400 patients across three distinct coronary stent platforms: the Platinum Chromium Element platform (ION Paclitaxel-Eluting Stent System (TAXUS Element) and PROMUS Element Everolimus-Eluting Stent System), the Xience V/PROMUS Everolimus-Eluting Stent System, and the TAXUS Express Paclitaxel-Eluting Stent System.
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Coronary stent system receives regulatory approval in India |
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| Stents
: 06 March, 2012 |
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Cappella Medical Devices receives regulatory approval in India for the company's flagship Sideguard Coronary Stent system which claims to offer superior outcomes in treating patients percutaneously for complex and bifurcated lesions. |
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Boston Scientific Epic stent shows positive clinical outcomes |
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| Stents
: 17 January, 2012 |
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Boston Scientific is reporting nine-month clinical endpoint data from its ORION trial, demonstrating excellent outcomes for the company's Epic Self-Expanding Nitinol Stent System in patients with iliac artery disease, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow. |
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OrbusNeich's Genous stent achieves good, comparable clinical outcomes |
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| Stents
: 09 January, 2012 |
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OrbusNeich is reporting 12-month follow-up data from a post-hoc analysis of the e-HEALING registry demonstrate that the company's Genous Stent achieves good, comparable clinical and safety outcomes in patients discontinuing dual antiplatelet therapy (DAPT) at 30 days and at six months.
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Carotid Wallstent found safe for high surgical risk patients |
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| Stents
: 10 November, 2011 |
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Boston Scientific is reporting positive outcomes from the CABANA post-approval study of the Carotid WALLSTENT Monorail Endoprosthesis used in conjunction with its FilterWire EZ Embolic Protection System in routine clinical practice.
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Svelte Medical systems treats first patient in DIRECT stent study |
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| Stents
: 10 November, 2011 |
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Svelte Medical Systems is reporting the treatment of the first patient in the DIRECT (Direct-on-a-wire Implantation of Rapamycin-eluting stent with bio-Eroding Carrier Technology) study at Auckland City Hospital in Auckland, New Zealand. |
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