CE Mark Approval

W. L. Gore & Associates, Inc. has received CE mark for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore® Excluder® AAA Endoprosthesis for treatment of abdominal aortic aneurysms(AAA). The company says its new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair.

Flexible Stent Solutions has been granted CE mark for an extended range of its Flexstent peripheral vascular stents. The new line, called Flextent Iliac, does pretty much what it says on the tin, extending the company’s offering to cover more vessels.

Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.

Maquet is trumpeting its new generation of antibiotic/silver treated vascular grafts which it claims are effective against MRSA. The graft, branded Intergard Synergy, has gained CE mark status and is ready for launch.

Endosense has announced that its TactiCath Quartz force-sensing ablation catheter has been CE mark approved. In cooperation with the company’s distributor Biotronik, first cases using the new device have been performed by renowned physicians at three centres across Europe.

Treatment of Refractory Epilepsy by Vagus Nerve Stimulation is to be made available in Europe as Neurotech’s unique rechargeable device gains CE mark approval.

NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, has announced that it has gained CE mark approval for the NvisionVLE™ Imaging System.

State of the art materials lie at the heart of this incredibly liberating exoskeleton for people with spinal cord injuries. The definition of a medical device, for CE mark purposes stretches from cranberry pills to exoskeletons it seems as Ekso Bionics announces gaining of clearance to market in Europe.

Hydrogel sealants have a habit of clogging in their applicator nozzles, a problem Hyperbranch reckon they’ve solved with their newly CE marked Adherus™ Autospray device.

Dual anti-platelet therapy is normally required for 6-12 months after implantation of a stent, with associated risks, costs and general inconvenience. No wonder then that Abbott is sounding pleased with itself as it gains the first indication of its kind to reduce the therapeutic period to a minimum of 3 months based on data from 10,000 patients.

EuroPCR is being held in Paris right now and is the European focal point for all things cardiovascular. St. Jude Medical, Inc. has chosen the event to announce CE Mark Approval and launch of its EnligHTN™ renal denervation system.

Boston Scientific Corporation has issued an announcement confirming CE Mark approval and European market launch of the Innova™ Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee.

You say potato, I say prosthesis. While somehow a therapeutic cranberry capsule has uniquely found its way to market as a medical device, we’re scratching our heads about the whole affair.

Californian company Vessix Vascular Inc has announced the CE marking of its rather clever RF balloon for renal denervation. The company claims its approach means faster treatment than the other systems on the market and its clinical performance will shortly be presented at the EuroPCR Conference in Paris May 15-18.

Another approach to reducing calorific intake is demonstrated with the newly CE marked Satisphere device, an endoscopically inserted series of balloons on a wire, which retain gut contents in the duodenum for longer, creating the feeling of satiation and therefore reducing appetite.

Single study shows novel hydrogel scaffold results in better wounds. Product gets CE mark. Should it really be that simple?