CE Mark Approval

Boston Scientific is having a good week, not least with the news that its super fine Emerge PTCA balloon catheter has gained its CE Mark.

St.Jude is making a big deal of the fact that it sought guidance from 200 physicians on the design of its newly CE marked Ellipse ICD device.

Impella cVAD from Abiomed looks like a great tool for the cardiologist faced with the need to provide short term haemodynamic support for cardiac patients, with the advantage that insertion is percutaneous.

Intact Vascular tells us a bit about its newly CE marked product and even refers us to its website for more information. Of which there is very little at this stage. How does it work, and what’s the plan for commercialisation? We’re looking forward to hearing because it sounds promising.

Boston Scientific has trumpeted the CE mark approval of its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers.

Teleflex has announced that following earlier US approval for its Arrow® VPS® (vascular positioning system), it has now gained CE mark approval and will be made immediately available in Europe.

If you’re going to the trouble to issue a press release, it really out to be a little more reader-friendly and maybe even contain some useful information. A wound spray to help chronic wounds heal sounds great, but most medical professionals might ask how (and how well) it works before they get too excited that it’s gained CE mark approval.

Medtronic gains CE Mark approval for its CD HORIZON BalanC™ Spinal Fusion System, promising a new level of adaptablity to patient anatomy.

Cervical Disc Replacement specialist Spinal Motion has announced the CE marking of its sub 5mm Kineflex|C iterations.

Using a Drug-coated balloon to implant a bare metal stent might just be a smart idea, at least according to Dutch Cardiovascular specialists Blue Medical in announcing the launch of their innovative new offering.

Baxano’s iO-Flex® Spinal Decompression System is heading to Europe with CE mark approval following its earlier FDA clearance.

Medtronic raises the bar in MRI compatible pacing leads with CE mark for its new small diameter offering.

Checkpoint’s newly CE marked device helps surgeons avoid nerve damage.

CE mark for clever Steerable Balloon from Osseon, which it claims challenges existing kyphoplasty systems.

It’s positive news for Ascendx with a new high profile board member, new distributors for its CE marked products in four European countries, and FDA clearance for its Acu-Cut Vertebral Compression Fracture Solution.

We’re a truly schizophrenic lot aren’t we? We embrace technology like this, then moan that we have lax regulatory control. Regardless of the argument, the fact is that this tiny Japanese company’s PLLA stent is approved in EU, but not USA or Japan.