The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.
Replacement Heart Valves
Valve-in-valve implantation for failed heart valves shows good short-term results
The short-term results of minimally invasive transcatheter valve-in-valve implantation to treat failed biological heart valve protheses are "excellent," but patients must be closely monitored due to some notable cases of suboptimal systolic-valve performance, according to early data from a multi-center trial.
New share buyback goads Edwards Lifesciences up 7%
Edwards Lifesciences (NYSE:EW) said it plans to buy back another $750 million worth of its own stock during the 2nd quarter, with CEO Michael Mussallem buying another $5 million worth on his own.
Chris Christie, Dick Cheney and the power of celebrity endorsements for medical devices
When the New York Post broke the story this week that New Jersey governor and presidential hopeful Chris Christie had underwent weight loss surgery using the LAP-BAND in February some on Wall Street bemoaned the rotund politicians timing.
Medtronic asks Supreme Court to overturn $74M loss against Edwards Lifesciences
Edwards Lifesciences wants more from Medtronic over CoreValve infringement
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.