Regulatory

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.

Custom Spine’s foray into MIS spinal surgery is kicked off this week with the news that its newly FDA cleared Securis cannulated pedicle screw system is on show at AANS Miami.

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.

A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.

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.

As public spats go, this one is going to take some beating. St. Jude is not looking like its in the mood to give up as it comes right back at Medtronic, Dr Hauser and Heart Rhythm.

Achieving device approval in Japan is a major undertaking, so Abbott must be delighted that its Xience Prime everolimus eluting stent has got the nod based on a robust body of clinical evidence.

Predictaresponse time. Heart Rhythm has refused to retract, which it was always likely to do. St. Jude might get the chance to respond in public as the journal offers to review its data.

Medtronic declares itself pleased, but in reality must be absolutely delighted by the news that FDA has allowed it to expand the indications for its CRT-D resynchronisation/defibrillator devices to now include patients with mildly symptomatic heart failure.

It’s all getting a bit heated as Medtronic and St. Jude lock horns again, this time over the Hauser publication in Heart Rhythm journal.

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.

According to St Jude, Dr Robert Hauser’s paper, accepted for publication in the Heart Rhythm Journal is biased and inaccurate, comparing apples with pears and peddling conclusions it’s own analysis cannot reproduce from the data set. Watch this space.

FDA draws attention to potential problems with Thoratec’s HeartMate II LVAS pump.

Useful little device, fiXate™ from Anulex Technologies Inc., has now had its indications extended by FDA, allowing for its use in securing intrathecal pain pump catheters.