Replacement Heart Valves
Edwards Lifesciences plunges on missed Q1 sales, lowered outlook
Symetis touts positive findings for its Acurate TA TAVI system
Swiss medical device maker Symetis released 30-day registry findings for its 2nd-generation transcatheter aortic valve implantation systems, touting high procedural success rates and minimal valve leakage.
Results from the SAVI postmarket registry highlighted findings from the 1st 250 patients implanted with Symetis’ Acurate TA TAVI system, which won European regulatory approval in September 2011.
FDA’s new global cardiovascular registry to start with transcatheter heart valves
The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.
The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."
Abbott Vascular warns on MitraClip
Abbott Vascular (NYSE:ABT) warned physicians about the slight risk that its MitraClip heart valve implant could be damaged if the device is misapplied during implantation.
Heart valves: St. Jude Medical champions Trifecta data
St. Jude Medical (NYSE:STJ) championed newly published results from the 4-year-old study it used to back its pre-market approval application for the Trifecta heart valve in The Journal of Thoracic and Cardiovascular Surgery.
FDA panel splits on Abbott’s MitraClip heart implant
FLASH: FDA panel votes 5-3 that benefits of Abbott’s MitraClip heart implant outweigh the risks
The FDA’s Circulatory System Devices Panel voted today to make its recommendation regarding Abbott’s (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.
FDA says it won’t recommend approval for Abbott’s MitraClip implant
Correction: March 20, 2013, at 11:40 a.m.: This article mistakenly stated that the FDA’s advisory panel recommended against approval for MitraClip. The recommendation came from the FDA’s internal reviewers prior to the panel meeting.
Looking back on a pretty sedate ACC
Sometimes the major annual medical meetings are jam-packed with significant and market-moving data. And then sometimes they’re like this year’s American College of Cardiology conference, with relatively limited useful data from an investing perspective.
Transcatheter mitral valves are going to the dogs
The field of transcatheter mitral valve repair may move more quickly in pet populations than it does in human medicine, according to a presentation during this week’s American College of Cardiology conference in San Francisco.
Researchers are hard at work on a technology, called MitralSeal, they they hope to bring to market to treat mitral valve regurgitation in dogs.