Just in case you have this device contact your doctor for an evaluation of risks.
http://dgnews.docguide.com/label-use-device-prevent-stroke-patients-af-prevalent-dangerous?
The Lariat device, which has been cleared by the US Food and Drug
Administration (FDA) for soft tissue approximation during surgical
procedures, is associated with a significant incidence of death and
urgent cardiac surgery during its frequent off-label use to prevent
stroke in patients with atrial fibrillation.
Following a systematic review of case reports and an FDA safety
database, researchers at the University of Pennsylvania Perelman School
of Medicine, Philadelphia, Pennsylvania, are calling for formal
controlled investigations into the safety and efficacy of off-label use
of the Lariat device, which has never been approved for treatment of
this condition.
Their findings are published this week in JAMA Internal Medicine.
“Not only do we believe that high-quality, randomised clinical trials
are necessary to determine the safety of the Lariat device for
off-label procedures, but our analysis raises broader issues with the
FDA 510(k) clearance protocol for medical devices,” said senior author
Jay Giri, MD, University of Pennsylvania. “We believe there needs to be a
method for reassessing the safety of a device that has been cleared for
one use but is being frequently used for a different purpose in
real-world practice."
“The 510(k) clearance protocol is providing a regulatory loophole
that allows manufacturers to avoid full safety and efficacy testing of
devices cleared for one purpose, but used in practice for another
higher-risk application,” he said. “”In addition to the Lariat, this
issue could be important for other devices used in complex procedures
that have been cleared through the 510(k) pathway.”
The current study consisted of 2 sources: a systemic review of
published reports, and an analytic review of the FDA Manufacturer and
User Facility Device Experience (MAUDE) database. For the systematic
review, the researchers searched PubMed, EMBASE, CINAHL, and the
Cochrane Library for any reports of outcomes associated with the use of
the Lariat device for left atrial appendage exclusion.
The researchers found 7 cases of urgent need for cardiac surgery
following use of the device (2.3% of the 309 procedures reviewed) and 1
death (0.3% of the 309 procedures), with an overall procedural success
rate of 90.3%. The analytic review of the FDA MAUDE database identified 5
adverse event reports that noted death and another 23 reports of cases
necessitating urgent cardiac surgery.
“The Lariat is an ingenious piece of engineering for closing the left
atrial appendage, but ingenuity does not guarantee safety and
efficacy,” said Dr. Giri. “The Lariat must be assessed as a device for
left atrial appendage exclusion with randomised, controlled trials
before widespread use is adopted by the medical community.”
SOURCE: University of Pennsylvania School of Medicine
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