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Stents
Drug-eluting balloon wins unanimous FDA panel vote
Stents : 22 July, 2014
CR Bard has won a unanimous vote from an FDA advisory panel for its drug-eluting balloon catheter, setting the stage for the device's full regulatory approval. Previously, the FDA disclosed the documents for its Circulatory Systems Devices Panel meeting on 12 June which reviewed the device.
 
European approval for coronary stent
Stents : 18 March, 2014
A platinum chromium coronary stent system from Boston Scientific will bring benefit to coronary patients in Europe after receiving CE approval
 
CE Mark achieved for oesophageal stent
Stents : 17 February, 2014
The WallFlex oesophageal stent from Boston Scientific has received CE Mark for the treatment of oesophageal strictures in Europe
 
Asian distribution agreement for stents
Stents : 10 January, 2014
Medical technology company to market self-apposing stents in the Asian region through distribution agreements signed in the region
 
Support agreement for drug eluting stents
Stents : 09 December, 2013
The Medicines Company enters agreement with Boston Scientific on providing support for hospitals using the Promus Premier drug eluting stent system
 
Membrane technology for peripheral stents
Stents : 21 November, 2013
A new polyethylene membrane material from DSM is available for use in stents for the treatment of peripheral artery disease
 
Aortic valve replacement device meets key performance measures
Stents : 04 November, 2013
Data presented at the TCT Conference shows how the Lotus Valve system for use with severe aortic valve stenosis patients has met key performance requirements
 
CE approval for aortic valve replacement technology
Stents : 29 October, 2013
The Lotus Valve transcatheter aortic valve replacement system from Boston Scientific has received CE approval
 
Trial results to be presented on self-apposing stent
Stents : 24 October, 2013
Results from trials using the Sirolimus-Eluting self-apposing stent from Stentys will be presented at the TCT event in San Francisco
 
InspireMD partners with HealthLink for global logistics and distribution services
Stents : 28 August, 2013
InspireMD completes the first phase of a manufacturing consolidation that is aimed at improving the company's long term gross margins.
 
Boston Scientific completes enrollment in SuperNOVA trial to evaluate Innova Self-Expanding Stent System
Stents : 20 August, 2013
Boston Scientific completes enrollment in the SuperNOVA trial - a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of the Innova Self-Expanding Stent System (Innova Stent System).
 
Cook Medical partners with IU Health to study peripheral arterial treatment
Stents : 30 July, 2013
Cook Medical is partnering with IU Health to evaluate a potential treatment for peripheral arterial disease (PAD), a vascular disease of the legs.
 
Self-apposing stent is approved in Europe for additional coronary indications
Stents : 11 July, 2013
STENTYS is commercializing in Europe the world's first and only Self-Apposing Stent to treat acute myocardial infarction (AMI), announced today that it received approval from its European Notified Body to expand the CE Mark indications of the Self-Apposing stent.
 
Cook Medical receives 510(k) clearance for the Evolution Biliary Controlled-Release Uncovered Stent
Stents : 06 June, 2013
The Food and Drug Administration grants 510(k) clearance for the Evolution Biliary Controlled-Release Uncovered Stent from Cook Medical.
 
World's first dual therapy stent improves delayed coronary artery healing associated with monotherapy DES
Stents : 29 May, 2013
OrbusNeich is launching what the company claims is the world's first dual therapy stent - the COMBO Dual Therapy Stent - to address the challenges of delayed healing of the coronary artery associated with monotherapy drug eluting stents (DES), the current standard of care for the treatment of coronary artery disease (CAD).
 
Two trials show positive results for drug-eluting stent technologies treating coronary heart disease
Stents : 27 May, 2013
Boston Scientific reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease.
 
Self-apposing stent reinforces strength of clinical results
Stents : 24 May, 2013
New one-year data is presented from the APPOSITION III clinical trial at the international EuroPCR conference in Paris, France.
 
Abbott receives CE Mark for world's longest coronary drug eluting stent
Stents : 22 May, 2013
Abbott receives the CE Mark in Europe for the XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD).
 
Trial shows Genous stent is associated with lower restenosis rate compared to bare metal stents
Stents : 22 May, 2013
OrbusNeich is reporting that the company's Genous Stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months.
 
Stentys enrolls first heart attack patient in US stent clinical trial
Stents : 21 May, 2013
Stentys enrolls the first patient in APPOSITION V, the pivotal FDA-approved IDE trial which will enable the company to apply for marketing approval of the Self-Apposing Stent in the USA.
 
St Jude Medical receives CE approval of 3-D vessel reconstruction technology to improve stent placement
Stents : 20 May, 2013
St Jude Medical receives CE Mark approval of the company's ILUMIEN OPTIS PCI Optimization System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease (CAD).
 
Sentrant Introducer Sheath receives the CE mark
Stents : 08 April, 2013
Medtronic's Sentrant Introducer Sheath receives the CE mark and will soon be launched internationally.
 
InspireMD receives CE Mark approval for carotid embolic protection stent
Stents : 18 March, 2013
InspireMD, the developer of the MGuard Embolic Protection Stent (EPS), receives CE mark approval for the company's self-expanding Nitinol carotid EPS.
 
Covidien completes patient enrollment in iliac stent clinical study series
Stents : 21 February, 2013
Covidien completes patient enrollment in the company's iliac stent clinical study series which is composed of two prospective, multinational, multicentre studies - VISIBILITY Iliac and DURABILITY Iliac.
 
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary stent receives CE Mark approval
Stents : 14 February, 2013
Boston Scientific receives CE Mark approval for the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation durable polymer drug-eluting stent (DES) technology, and is starting its European market launch.
 
First patient starts treatment in the DIRECT II drug-eluting stent study
Stents : 01 February, 2013
The first patient begins treatment in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium.
 
Covidien receives CE Mark approval for one-handed self-expanding peripheral stent
Stents : 28 January, 2013
Covidien receives CE Mark approval for the company's EverFlex Self-expanding Peripheral Stent with Entrust Delivery System.
 
New drug eluting stent system offers delivery benefits
Stents : 04 January, 2013
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.
 
FSS introduces reconstrainable stent delivery technology in Europe
Stents : 24 December, 2012
Flexible Stenting Solutions receives the CE Mark and is to market the company's 6 Fr Reconstrainable FlexStent Self-Expanding Stent System in the European Union.
 
First patient starts treatment in the ACES effectiveness study
Stents : 21 December, 2012
Svelte Medical Systems is reporting the treatment of the first patient in the ACES (Acrobat Coronary stent system effectiveness European Study) clinical trial by Victor Legrand, MD, PhD at CHU Liege in Liege, Belgium.
 
First US patient is treated with first-of-its-kind drug-eluting peripheral stent
Stents : 19 December, 2012
Riverside Methodist Hospital in Columbus, Ohio, USA, is treating the first patient with Cook Medical's Zilver PTX drug-eluting peripheral stent just weeks after the US Food and Drug Administration (FDA) approved the device.
 
First patient enrolls in multicentre study of the SYNERGY coronary stent system
Stents : 03 December, 2012
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.
 
Largest prospective study shows IVUS-guided stent placement improves patient outcomes
Stents : 20 November, 2012
Volcano is reporting results from the largest study of its kind show that stent procedures guided by intravascular ultrasound (IVUS) resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.
 
Zilver PTX stent achieves FDA approval as first drug-eluting stent in US to treat peripheral arterial disease
Stents : 20 November, 2012
Cook Medical receives US Food and Drug Administration (FDA) marketing approval for the first devices in its Zilver PTX Drug-Eluting Peripheral Stent portfolio, company officials reported today. It’s the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.
 
SRS Medical acquires The Spanner Prostatic Stent from AbbeyMoor Medical
Stents : 05 November, 2012
SRS Medical acquires The Spanner Temporary Prostatic Stent from AbbeyMoor Medical of Parkers Prairie, Minnesota, USA.
 
MAQUET joins Stent For Life Initiative
Stents : 30 October, 2012
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.
 
PROMUS Element platinum chromium stent demonstrates positive outcomes in patients with long coronary lesions
Stents : 26 October, 2012
Boston Scientific is reporting clinical endpoint data from the PLATINUM Long Lesion trial, demonstrating positive outcomes for the PROMUS Element Everolimus-Eluting Platinum Chromium (PtCr) Stent System in patients with long coronary lesions.
 
STENTYS receives FDA approval to begin first US clinical trial with self-apposing stent
Stents : 24 October, 2012
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).
 
Svelte receives FDA approval to begin a study of coronary Stent Integrated Delivery System
Stents : 23 October, 2012
Svelte Medical Systems receives conditional approval from the FDA to begin a pivotal study for the Svelte coronary stent Integrated Delivery System (IDS).
 
Zilver PTX stent trial shows sustained patency after three years
Stents : 15 October, 2012
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.
 
Cook Medical launches Zilver Vena venous self-expanding stent in Canada
Stents : 09 October, 2012
Following Health Canada approval, Cook Medical is making the Zilver Vena Venous Self-Expanding Stent available to physicians across Canada at the 2012 Annual Meeting of the Canadian Society for Vascular Surgery.
 
New stent-delivery system facilitates implantation in more complex vessel anatomies
Stents : 28 September, 2012
STENTYS is releasing Europe an enhanced stent-delivery system for the company's self-apposing stent.
 
Boston Scientific launches drug eluting stent to treat severe lesions below the knee
Stents : 27 September, 2012
Boston Scientific is launching in European countries the PROMUS ELEMENT PLUS BTK (Below The Knee) Everolimus-Eluting Stent System for the treatment of certain severe peripheral artery lesions.
 
XIENCE Xpedition Everolimus eluting stent receives CE Mark
Stents : 21 August, 2012
Abbott's XIENCE Xpedition Everolimus Eluting Coronary Stent System receives CE Mark in Europe for the treatment of coronary artery disease.
 
Trial data shows stent delivers higher freedom from Target Lesion Revascularization rates
Stents : 14 August, 2012
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.
 
AXIOS stent and delivery system for biliary tract drainage receives CE Mark approval
Stents : 19 July, 2012
Xlumena receives CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage.
 
Cook Medical receives 510(k) for Evolution colonic controlled-release stent
Stents : 10 July, 2012
The US Food and Drug Administration (FDA) grants Cook Medical 510(k) clearance for Cook Medical's Evolution Colonic Controlled-Release Stent.
 
Stent shows strong performance in CAD patients with and without diabetes
Stents : 29 May, 2012
The Resolute drug-eluting stent (DES) from Medtronic is shown in a new study to yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up.
 
Cook Medical launches first drug-eluting stent in Australia to treat PAD
Stents : 22 May, 2012
Cook Medical is launching a first-of-its-kind drug-eluting peripheral stent in Australia, the Zilver PTX Drug-Eluting Peripheral Stent.
 
Boston Scientific receives FDA approval of EPIC vascular stent
Stents : 21 May, 2012
Boston Scientific receives US Food and Drug Administration approval and is launching the Epic Vascular Self-Expanding Stent system.
 
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