Interventional Cardiology

Cardiosolutions Inc., has announced that it has received FDA 510(k) clearance to market its Dexterity Steerable Introducer, a next generation structural heart access introducer and delivery conduit.

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.

The U.S. FDA has approved revised product labeling for the Boston Scientific Corporation INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices.

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.

Results presented at EuroPCR demonstrate minimally invasive “Parachute” device from CardioKinetix could transform treatment options for patients as two year results suggest significant improvement in condition.

Edwards Lifesciences’ Sapien XT may not be FDA cleared, but in Europe at least the company is generating a nice body of data suggesting that at least in the short term the valve performs well in high risk patients. These data have been presented at EuroPCR 2012 in Paris this week.

It’s EuroPCR week, so cardiothoracic companies are timing their press announcements to coincide with the event. Californian company Elixir Medical’s fully bioabsorbable drug eluting coronary scaffold has been the subject of what looks like a very promising clinical study presented during the event.

MAQUET Cardiovascular LLC has announced that it has received FDA 510(k) clearance for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater haemodynamic support, regardless of their height.

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.

Following CE marking earlier this year, Heart Rhythm 2012 sees Sorin announce FDA approval and US launch of its new pacing, defibrillation and left ventricular leads.

Biotronik ticks another big box with the FDA clearance of its Lumax 740 ICDs and CRT-Ds equipped with home monitoring, supporting the company’s claim to have the only CE and FDA approved remote cardiac patient management system for early detection of clinically relevant events.

Which ever technology the future of atrial fibrillation therapies lies in, this new report from UK consulting firm Cambridge Design Partnership claims to have it covered. And its available on request!

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.

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.

Sounds like a simple idea cleverly executed, which makes University of Limerick researcher Dr Michael Walsh’s claims that this new balloon angioplasty device may advance the technique sound reasonable.