Heart Valves

CardiaQ Valve Technologies has waited for the moment when its percutaneous mitral valve was first deployed in man, and it has now announced that’s occurred in what is believed to be a world first and a clinical milestone.

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.

It seems members of the FDA Circulatory Devices Advisory Panel have satisfied themselves that the benefits of Edwards’ Sapien heart valve outweighed the risks for as it voted 11-0 in favour of approval of the device for use in high risk patients. The final decision will now rest with FDA itself.

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.

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.

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.

Edwards Lifesciences is trumpeting the newly released results from a study of its Intuity Valve System, which suggests small incision surgery is fast, safe and clinically effective.

Regulatory approval is one step closer with Boston Scientific’s announcement that its REPRISE I Clinical trial of the Lotus TAVR system has completed enrollment.

ACC sees presentation of data from study in severe aortic stenosis patients treated with Edwards Sapien TAVR option. Results are reassuringly equivalent to open heart surgery, suggesting this may be an additional option in patients not suitable for major surgery.

Medtronic announces strong clinical outcomes for its Corevalve product at ACC meeting.

Freeze dried heart valve material holds promise as a scaffold. Researchers have investigated different techniques in order to optimise the resultant material.

Edwards Lifesciences Corporation, today announced that it has received CE Mark in Europe for its INTUITY Aortic Valve System.

Brazilian developers of the Inovare transapical aortic valve are encouraged by the early experience with the device despite a 50% two-year mortality rate.

An expanded patient group in the PARTNER heart valve study suggests a trend towards enhanced survival, reduced symptoms and stroke risk.

Medtronic gets a little closer to market (in USA) with the announcement that CoreValve’s extreme risk group enrollment is now complete.

Results from “high-surgical-risk” study arm of MitraClip EVEREST II trial suggest the device does provide limited reduction in mitral regurgitation in patients for whom surgery is not an option.