Medtronic, Inc. has announced the CE (Conformité Européene) mark and international launch of the Resolute Integrity Stent System for the treatment of coronary artery disease, a leading cause of death and poor quality of life. The Resolute Integrity Stent System features a novel drug-eluting coronary stent with superior deliverability the ability of the device to traverse the patient’s vasculature and reach the blockage in the heart artery.

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Svelte™ Medical Systems, Inc. has announced that it has officially received the CE Mark to market its Acrobat  Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union. The Acrobat  SOAW stenting system has been shown in clinical trials to facilitate direct stenting and has the potential to provide substantial procedural time and cost savings. These savings are realized by eliminating the need for a coronary guidewire and balloon dilatation catheters.

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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 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 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.