Heart Valves

New data, presented at TCT 2012 from the ADVANCE registry, confirms that mortality rates with transcatheter aortic-valve implantation (TAVI) using Medtronic’s CoreValve have dropped steadily since the devices’ earliest clinical trials.

Edwards Lifesciences reported third quarter results showing global THV Sales grew 50% with EPS up 35 Percent (53 Percent Excluding Special Items). Fourth quarter sales and earnings guidance trimmed and still heavily reliant on Sapien uptake.

Such is the buzz around transcatheter heart valve replacement that the FDA has seen fit to issue a press release giving its own interpretation of the approval issued to Edwards’ Sapien valve for patients considered high risk for conventional surgery.

Edwards Lifesciences’ long wait for an extended indication for its Sapien Valve is over with the news that FDA has rubber stamped the guidance from its summer expert circulatory panel meeting.

Loma Vista Medical says its World first ultra-precise balloon is specifically designed to prevent balloon ruptures in TAVI and BAV procedures. Catch it at TCT 2012.

Boston Scientific has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus™ Valve System and the results are expected to be used to support CE mark and other international regulatory approvals.

TAVI is a great case study in technology adoption, most strikingly pointing to post-market data in the form of registries as a window on real world use of a technique which actually makes for a pretty compelling endorsement of EU regulatory rules.

Medtronic announces CE mark for CoreValve® Evolut™, incorporating features designed for optimal fit. With the new 23mm iteration, Medtronic claims its CoreValve family treats the broadest range of patient valve sizes.

Sorin has announced CE Mark approval for extended indications of the Perceval™ S sutureless valve, expanding the market and, the company says, paving the way for adoption of Minimally Invasive Cardiac Surgery

It’s an understatement to say that mitral valve replacement is a tricky business, so it’s unsurprising to see Neovasc trumpeting early successes in an about-to-be published preclinical study.

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.

OK it’s all work supported by the main industry players, but a registry’s a registry and in Germany it appears that the body of evidence is growing that TAVI is a technique that is gaining ground for all the right reasons and could even usurp conventional surgery in years to come.

Registry data presented at ESC suggests MitraClip use is gathering pace, at least for the oldest and sickest patients for whom it is providing an alternative to surgical valve repair.

Edwards Lifesciences was not likely to let a BMJ article go unanswered, so it’s unsurprising to see the purveyor of the Sapien transcatheter valve issuing a stout defence of the clinical evidence behind its baby. But as a clinician, what are you supposed to do?… wait until the body of evidence is so significant as to be incontrovertible, or use your own judgement within the confines of regulatory approval?

Belgian researchers have stirred up a hornets nest with their assertion that evidence for TAVI means its use should be more limited than is the case, and furthermore that we’re still not getting the whole picture.

Edwards Lifesciences Corporation has released its second quarter financial results which are, on face value, bucking the trend by showing sales growth of almost 16% (albeit excluding currency impact) to $482m compared with the equivalent period last year. Closer examination reveals that growth is almost exclusively related to the company’s Sapien transcatheter heart valve, launched in U.S and seeing continued growth internationally.