Cardiology Product Guide » CE Mark

Boston Scientific Launches Platinum Chromium TAXUS(R) Element(TM) Stent System

Jim Marino — Fri, 11 Jun 2010 09:08:28 +0000

Boston Scientific Corporation has announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included an indication for the treatment of diabetic patients.

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Abbott Launches TREK(TM) Catheter System in Europe

Jim Marino — Fri, 28 May 2010 10:57:50 +0000

Abbott announced the European approval and launch of its TREK(TM) Coronary Dilatation Catheter for the treatment of coronary artery disease. The TREK system represents a new approach to balloon catheter design, and provides physicians with a high-performing option for treating challenging lesions and difficult-to-reach blockages. Abbott received CE Mark for the TREK system earlier this year. The TREK family is a completely re-engineered line of balloon catheters, incorporating many advanced design and technology changes.

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Boston Scientific Announces European Approval and Launch of Platinum Chromium PROMUS(R) Element(TM) Stent System

Jim Marino — Tue, 01 Dec 2009 13:04:09 +0000

Boston Scientific Corporation has announced that it has received CE Mark for its PROMUS® Element(TM) Everolimus-Eluting Coronary Stent System, the Company’s third-generation drug-eluting stent (DES) technology. The PROMUS Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The Company will begin marketing the PROMUS Element system immediately in the European Union and other CE Mark countries.

CE Mark approval for Cook Medical’s microcatheter

Jim Marino — Wed, 29 Oct 2008 14:04:46 +0000

Cook Medical has received the CE Mark approval for its MiraFlex™ High Flow Microcatheter. Designed to complement the company’s existing embolisation products and coils, the device represents the newest improvement in micro-catheter technology. It enhances traceability necessary to access the most distal vasculature. Having an inner diameter of .025 inch, the catheter is approved for use in small vessels. It enables coil delivery in the finest way.

St. Jude Medical’s SJM Confirm™ receives CE Mark

Jim Marino — Fri, 17 Oct 2008 04:34:33 +0000

St. Jude Medical, Inc. has received CE Marking for its implantable cardiac monitor (ICM), SJM Confirm™. The most compact ICM in the market (equal to the size of a thumb drive) is designed for the detection of atrial fibrillation and other abnormalities in heart rhythms. The device is implanted subcutaneously, just under the skin near the upper part of the chest. It can also be implanted, under local anesthesia, in an outpatient application. The system’s sensing algorithm helps in detecting small, wide-ranging signals in a better way.

OrbusNeich Sapphire catheter receives CE Mark approval

Jim Marino — Thu, 14 Aug 2008 15:38:06 +0000

OrbusNeich’s Sapphire(TM) 1.25mm PTCA dilatation catheter has received the CE Mark approval, a company announcement says. The product is slated for immediate roll-out. It affords greater pushability and superior kink resistance to the physicians. According to Professor Tan Huay Cheem of the University Hospital in Singapore, the product may be considered to be a first choice for the treatment of highly stenotic lesions.

ES Vascular gets CE Marking for OAS system

Jim Marino — Wed, 09 Jul 2008 19:56:46 +0000

ES Vascular has announced that it has received a CE Marking approval for its Open Aortic Stapler (OAS) system. The OAS system is to be used for mechanical suturing technology of aortic synthetic grafts during open repair of AAA and other aortic reconstructions. The approval allows commercialization of the device in most European countries.

MGuard coronary stent trial depicts positive efficacy and safety data

Jim Marino — Thu, 26 Jun 2008 20:21:25 +0000

InspireMD has achieved positive results with its MGuard coronary stent in an ongoing multicenter trial aimed at establishing the safety and efficacy of the product in high-risk patients with complex lesions. The study’s six-month data demonstrates no thrombosis and an overall MACE rate of 6.6%. The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, according to the company. The product, which combines a coronary stent with an embolic protection device, has received a CE Marking to treat patients with coronary artery diseases.

Boston Scientific receives CE Marking for ALTRUA pacemakers

Jim Marino — Tue, 24 Jun 2008 20:25:41 +0000

Boston Scientific Corp. was given European CE Marking for its new ALTRUA family of pacemakers. ALTRUA pacemakers are used to treat bradycardia, a condition in which the heart beats too slowly. ALTRUA is flexible and features a sensor to regulate the heart after experiencing physical activity or emotional stress and an automatic capture capability designed for automatic and accurate ventricular pulse management.

Medtronic Defender embolic protection filter gets CE marking

Jim Marino — Tue, 29 Apr 2008 20:21:00 +0000

Medtronic Inc. has received CE marking approval for the Defender embolic protection filter to be used during minimally invasive procedures in carotid arteries and saphenous vein grafts. The filter acts as a basket during the stenting procedure, allowing sufficient blood flow while trapping embolic debris. Without this protection, the debris can flow into other portions of blood vessels and lead to stroke.