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.

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, 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’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 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.

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 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 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.

Boston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.