St Jude

Occlusion of the Left Atrial Appendage has become a recognised preventative measure in the AF patient, this anatomical feature being the source of the majority of clots. Now occlusion has been made easier with the CE marking and introduction of a next generation device from St.Jude Medical, Inc.

St. Jude Medical, Inc. has gained U.S. FDA approval for its next-generation Merlin.net™ Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

It’s a boardroom thriller of a story, a David and Goliath tale of intrigue and no little desperation. Quite what the board of AorTech or for that matter St.Jude have gone through over the past year, goodness knows, but it looks like the turbulent waters have stilled at last.

St.Jude’s shareholders are a resilient lot. It’s been bad stuff on top of bad stuff for ages, but now that Durata seems to be weathering the storm and the coating supply deal is secured, there’s just the simple matter of dealing with a stern warning letter from the FDA over its practices.

St. Jude Medical, Inc. revenues for the quarter just ended again showed a decline compared with the equivalent period a year ago, although the drop-off was overall slightly less marked than it had been in Q3. And the bottom line held up as cost saving measures played out.

Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic.

A therapy as potentially huge as renal denervation is bound to be tied up in claim and counterclaim, and downright confusion about who owns what. A new article tries to unpick it all.

St. Jude Medical, Inc. has announced the first patient enrollment in its ILUMIEN I clinical study, designed to show the way Optical Coherence Tomography can optimally guide stent implantation in patients with coronary artery disease.

St. Jude’s CE Mark for its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)brings to the market a family of devices featuring new algorithms, designed to help protect patients against inappropriate shocks.

St. Jude Medical, Inc. has announced the first patient implant of its 23 mm Portico™ Transcatheter Aortic Heart Valve using the Transapical Delivery System.

The FDA has published its inspection notes from recent visits to St.Jude’s Durata plant and they don’t make pleasant reading for the company. I dare say, if I was the FDA inspector and knew the history I might be a tad pedantic, but this lot reads like a catalogue of shortfalls.

St.Jude Medical, Inc.says its newly CE marked transcatheter valve is uniquely re-sheathable prior to full deployment, so could potentially lead to improved, accurate placement and reduced paravalvular leak compared with the first generation products.

Gore REDUCE Clinical Study investigators implored to continue enrollment, and drive ‘Diligent Continuation of Study’ in an effort to generate PFO data that principals believes will be significant if inclusion and exclusion criteria are adhered to and clinical bias reduced.

Wouldn’t you love to be fly on the wall at ST.Jude’s exec offices when they see an analyst talking knowledgeably about molecules with the obvious consequence that Durata’s lead coating gets questioned… again. Despite sound clinical data, it seems they just can’t win as the nay sayers dig up anything to raise the spectre of potential disaster.

Will they, won’t they? The current standoff between St.Jude and AorTech, the supplier of its seemingly rather effective Optim ICD coating material will either end in tears of nuptial joy or something rather more ugly as St.Jude wins its injunction against AorTech’s threatened termination of their supply agreement.

Data from the St.Jude EnligHTN I multi-electrode renal denervation catheter study presented at the annual scientific meeting of the American Heart Association suggests blood pressure reduction is sustained at six months.