Cardio

InspireMD has announced that its president and co-founder Asher Holzer, Ph.D., is retiring as president of the Company.

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.

Smart move for Cyberonics as it spots an opportunity to tap into Imricor’s MRI-compatible lead capability for its own neuromodulation products.

FDA’s executive summary of the state-of-play going into tomorrow’s circulatory devices panel meeting is exhaustive, thorough and actually pretty impressive. Yet again though it raises the question of when enough data is enough, because no doubt Edwards Lifesciences thinks its study already looks under every rock.

CardioKinetix Inc claims its PARACHUTE III Clinical Trial will evaluate benefits of this new therapy in a real-world setting as it commences enrollment with cases in Germany.

A new market research report has been published which claims bare metal stents will account for $1.86Bn sales by 2015. And if you buy it you get a free hour with an analyst.

Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.

Boston Scientific has finalised its acquisition of Cameron Health and in so doing adds the first and only commercially available subcutaneous “leadless” ICD technology to its portfolio.

Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths (32mm and 38mm) of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, opening the door for the treatment of longer lesions.

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.

MAQUET Cardiopulmonary, has announced that it has signed an agreement with Avalon Laboratories to acquire its Avalon Elite® Bi-Caval Dual Lumen Catheter and complimentary vascular access kits for use during Extracorporeal Life Support.

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.

InspireMD has announced that it has completed enrollment in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial and is on track to release preliminary top line results in the third quarter of 2012.

According to study results presented at the American Association of Clinical Endocrinologists (AACE) 21st Annual Scientific and Clinical Congress in Philadelphia, Medtronic’s Resolute® drug-eluting stent (DES) from Medtronic, Inc. yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up.

In the same week that the device giant Medtronic announced better than expected financial results including headline items like a 28% year-on- year quarterly earnings increase, it has also been revealed that the company is to shed around 1000 jobs.

Boston Scientific Corporation took the opportunity presented by EuroPCR to announce “excellent” two-year results from the PLATINUM Small Vessel study.