Cardio

We don’t normally cover company puff about awards, but as it’s the evocatively named Copper Cactus Awards in Arizona we couldn’t resist. And in any event, SynCardia’s total artificial heart is always newsworthy.

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.

An orbital sander may sound like a slightly risky thing to be pushing through your average calcified plaque deposit, but following a successful first study, Cardiovascular Systems has now completed enrollment in a second, US-based study in coronary artery patients.

Less than two months after giving Sunshine Heart the conditional approval to start its IDE study of the effectiveness of its C-Pulse® system in alleviating the condition of heart failure patients, the agency has now rubber stamped the study by removing the conditionality.

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, has announced the completion of enrollment in the Tryton Pivotal IDE trial evaluating its Side Branch Stent.™

Sorin’s investment in HighLife SAS will fund development of an innovative percutaneous mitral valve replacement technology, over which the Italian heart company will retain an option to buy.

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

Boston Scientific will feel they have stolen some solid commercial ground with the news that, in Europe they can now claim extended life from their defibrillator ranges thanks to their new battery technology.

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.

The FDA has issued a Class I recall, it’s highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose.

The U.S. FDA has approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

At TCT 2012, Volcano Corporation announced results from the largest study of its kind, showing that stent procedures guided by intravascular ultrasound resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.

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.

Abiomed’s Impella® devices are fiendishly clever little pumps for use in heart failure patients. The company has now received FDA approval to commence an IDE study on its new Impella RP device which it hopes will pave its way to U.S. humanitarian device exemption.

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.