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Promus Premier Coronary Stent System Has Obtained an Approval From The US FDA

Nov 27, 2013

US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system. The company's next-generation durable polymer ...

Tags: Coronary Stent System, Boston Scientific

Svelte Medical Had Completed Enrollment in Its DIRECT II Drug-Eluting Stent Clinical Study

Nov 22, 2013

Svelte Medical Systems (New Providence, NJ) announced that it had successfully completed enrollment in its DIRECT II drug-eluting stent clinical study. The trial is designed to study the safety and efficacy of the company’s ...

Tags: Svelte Medical, Enrollment, DIRECT II

ITGI Medical Has Signed a Strategic Cooperation Agreement with Vascular Solutions

Nov 14, 2013

Israeli bio-medical engineering company ITGI Medical has signed a strategic cooperation agreement with Vascular Solutions, a medical device company, to commercialize ITGI's Aneugraft Dx coronary covered stent in the US market. Pursuant to ...

Tags: ITGI Medical, Aneugraft DX Stent

Biomedical Obtained CE Mark Approval for Its Pk Papyrus Covered Coronary Stent System

Nov 7, 2013

Germany-based biomedical technology company Biotronik has obtained CE Mark approval for its PK Papyrus covered coronary stent system for use in the treatment of acute coronary artery perforation. According to Biotronik, the company's PK ...

Tags: Coronary Stent System, Medicine

Micell Has Received CE Mark Clearance for Its Mistent Ses

Jun 14, 2013

Micell, a US-based biomedical company, has received CE (Conformité Européenne) Mark clearance for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). MiStent Sirolimus Eluting Absorbable ...

Tags: Micell, Mistent SES

Two-Year Results From Excella BD Randomized Clinical Trial Was Announced by Elixir Medical

May 27, 2013

US-based medical devices developer Elixir Medical has announced that the results of its CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating were outstanding. Its CE Mark-approved DESyne BD ...

Tags: Elixir Medical, BD Randomized Clinical

MGuard Embolic Protection Stent Is Launched by InspireMD

Apr 25, 2013

InspireMD has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to initiate MASTER II clinical study of its MGuard embolic protection stent (EPS). The CE-marked ...

Tags: InspireMD, Protection Stent Study

Abbott Has Obtained Regulatory Approval for Its Eluting Coronary Stent System

Jan 4, 2013

Abbott has obtained regulatory approval for its XIENCE Xpedition Everolimus Eluting Coronary Stent system,designed for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary ...

Tags: Abbott, FDA, Drug Eluting System, XIENCE, symptomatic heart disease

Svelte Medical Systems Has Treated The First Patient in The ACES Clinical Trial

Dec 31, 2012

Svelte Medical Systems has treated the first patient in the ACES (Acrobat Coronary stent system effectiveness European Study) clinical trial. ACES is a randomized, controlled study to show the clinical benefit and utilization of the ...

Tags: Svelte Medical Systems, clinical trial, ACES, company news

The First Patient Has Been Treated by Svelte Medical Systems Aimed to Treat Diseases

Dec 25, 2012

Svelte Medical Systems has treated the first patient in a randomized, controlled study using its fixed-wire based system, designed for treating patients with coronary artery lesions. The low profile Svelte Acrobat Integrated Delivery ...

Tags: Svelte Medical Systems, fixed wire based system, coronary artery lesions

Boston Scientific Has Obtained CE Mark Approval for Its Synergy Bioabsorbable

Dec 18, 2012

Boston Scientific has obtained CE mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, designed to improve post-implant vessel healing. The coronary stent, which features a combination of ...

Tags: CE Mark, post-implant vessel healing, coronary stent

Abbott's Everolimus Eluting Coronary Stent System Has Been Accorded with CE Mark

Dec 18, 2012

Global healthcare firm Abbott's everolimus eluting coronary stent system has been accorded with CE Mark in Europe. The XIENCE Xpedition everolimus eluting coronary stent system, which is used to treat coronary artery disease, provides ...

Tags: Abbott, CE mark, coronary stent system, coronary artery disease

Cardionovum Plans to Launch Its New Sirolimus-Eluting Coronary Stent System

Dec 17, 2012

Cardionovum is planning to launch its new Sirolimus-eluting coronary stent system, Prolimus Biograde, in Q4 2012. The new Prolimus Biograde features thin-stent strut design of just 71 microns which is designed to provide uniform stent ...

Tags: Cardionovum, Sirolimus-eluting coronary stent system, clinical product

Elixir Gains CE Mark Approval for DESyne BD Novolimus Eluting Coronary Stent System

Dec 17, 2012

Elixir Medical has gained CE Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating. The Elixir DESyne BD stent leverages the technology that enables an ultrathin (< 3 microns) polymer ...

Tags: Elixir Medical, Elixir DESyne BD stent, biodegradable polymer coating

Boston Scientific Receives FDA Approval for New Lengths of Promus Plus Stent System

Dec 17, 2012

Boston Scientific has received the US Food and Drug Administration (FDA) approval for 32 mm and 38 mm lengths of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent system. The Promus Element Stent is made with a ...

Tags: FDA, Boston Scientific, Promus Element Stent, coronary artery disease

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