St Jude

St. Jude Medical, Inc. has received FDA clearance and will immediately launch the Amplatzer™ Vascular Plug 4 for use in transcatheter embolisation procedures within the peripheral vasculature.

The news that FDA’s MAUDE database of adverse events has reported an “externalisation” of St.Jude’s new and improved ICD lead is bad timing and bad news for the company.

FDA’s circulatory devices panel review meeting last week, a routine scheduled event, has been widely reported as ordering some sort of panic stricken review of St.Jude’s Amplatzer® device. The reality was altogether less of a headline grabber.

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.

St.Jude clearly wants to remind its audience that it’s a company at the forefront of cardiac electrophysiology, and has timed a flurry of good news press releases to coincide with Heart Rhythm 2012.

ICD lead session at Heart Rhythm meeting, as reported by cardiac electrophysiologist John Mandrola, sounds like it gave the subject a thorough going-over and concluded that St.Jude’s Durata appears to significantly outperform its predecessor, while not yet having a big enough body of data behind it to convince the naysayers.

St.Jude Medical’s Bi-Annual Product Performance Report highlights positive results for its Optim coated leads, while also accepting an ongoing problem with older Riata products.

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.

Beautiful kids make great poster girls for campaigners trying to cut regulatory red tape and speed new technologies to market. But will the balance between too strict and too lax ever end up as “aaah, just right”?

More pacing leads from St.Jude are now at risk of externalisation according to a new MHRA medical device alert.

We’ve had to add a new tag… Alliances… because we don;t think this will be the last. St.Jude and Abbott’s “Choice Alliance” means they can both offer fuller bags in US contracts. Wonder how they’ll sort out the head to heads… I got there first. No I got there first.

Given the furore, it’s no surprise that St.Jude’s Cardiac Rhythm Management sales dipped in Q1 2012. While overall company sales grew, the net effect on the bottom line was a reduction from $233M to $212M compared with the equivalent quarter a year ago.

The first patient has been implanted with St.Jude’s Accent MRI® Pacemaker in a study to determine whether the device will be compatible with full body MRI scans once in situ.

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.

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.

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.