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Boston Scientific's Direxion Torqueable Microcatheter Obtains FDA and CE Mark Approvals

Nov 22, 2013

Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...

Tags: Boston Scientific, Microcatheter

Russian Firm Was Licensed to Use The Hydromer Hydrophilic Coating on PTC Microcatheters

Jul 18, 2013

Hydromer and the Russian Cardiovascular Catheter company have entered into an agreement, under which the Russian firm is licensed to use the Hydromer hydrophilic coating on its percutaneous transluminal coronary angioplasty (PTCA) ...

Tags: Russian Firm, PTCA Microcatheters

Boston Scientific Secured 510(K) Approval From The US FDA and CE Mark

Jul 16, 2013

Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets. The ...

Tags: Health, Medicine, Guidezilla Guide Extension Catheter

Medtronic Has Received Both FDA and The CE Approvals for Peripheral Angioplasty Balloon

Jun 6, 2013

Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon ...

Tags: Angioplasty Balloon, Medicine

Medtronic's Sentrant Introduces Sheath for The Endovascular Repair of Aortic Aneurysms

Apr 8, 2013

The European Union (EU) has granted CE mark certification to Medtronic's Sentrant Introducer Sheath for the endovascular repair of aortic aneurysms. Designed for use with the company's Endurant II AAA and Valiant Captivia Stent Graft ...

Tags: aortic aneurysms, Medtronic, Sentrant Introducer Sheath

GORE Dryseal Sheath with Hydrophilic Coating Is Introduced by Gore in Europe

Jan 25, 2013

W. L. Gore & Associates has announced European launch of improved GORE DrySeal Sheath with hydrophilic coating which allows for easier insertion and removal from blood vessels while performing endovascular repair procedures. The CE-marked ...

Tags: W.L.Gore&Associates, GORE DrySeal Sheath, hydrophilic coating

Cosmotec Has Obtained Shonin Approval From Japanese Ministry of Health

Jan 4, 2013

Cosmotec, a distribution partner of Endologix in Japan, has obtained Shonin approval from Japanese Ministry of Health, Labor and Welfare (MHLW) for its IntuiTrak Delivery system. Featuring a simplified deployment mechanism and hydrophilic ...

Tags: Cosmotec, Endologix, Japan, Shonin approval, MHLW

the New Flexible-Tip SuperCross FT Microcatheter is Introduced by Vascular Solutions

Dec 19, 2012

Vascular Solutions has introduced a new flexible-tip SuperCross FT microcatheter to provide superior deliverability over a guidewire in tortuous anatomy. Available in 130cm and 150cm lengths, SuperCross FT has an embedded gold distal ...

Tags: microcatheter, tortuous anatomy, clinical technology

Endurant II AAA Stent Graft System Is Introduced by Medtronic in US

Dec 18, 2012

Medtronic has introduced the Endurant II AAA Stent Graft system in the US, following the US Food and Drug Administration's (FDA) approval. The Endurant II AAA Stent Graft system is designed for the treatment of abdominal aortic aneurysms ...

Tags: Medtronic, Endurant II AAA Stent Graft system, FDA, EVAR

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