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Lariat Suture Delivery Device News

The LARIAT Suture Delivery Device tool made an exciting entrance into the medical field and surgeons were, and still are, excited about this new option to use with their patients.

This is a small tool, cleared by the FDA, to deliver an already tied stitch that is at the end of the tool to help in closing soft tissue during surgery. Soft tissues are the tendons, ligaments, skin, muscles, nerves and blood vessels in your body. The benefit of using this LARIAT tool is that when the stitch is put in place, there are no other pieces such as a clip or medical piece that is left in your body.

Manufactured by SentreHEART, one of the ways that surgeons have been using this tool for is with heart patients such as yourself who have Atrial Fibrillation (A-Fib). According to the American Heart Association, an estimated 2.7 million Americans are living with A-Fib and are at risk for blood clots, stroke, and heart failure and many cannot tolerate blood thinning medications. Taking blood thinners helps prevent clots from forming in your body.  

Is the Lariat Suture Delivery Device Safe

The LARIAT tool is used to put a stitch around your Left Atrial Appendage and to tie it off by putting the end of the tool, which looks like a “lasso”, around this and squeezing this lasso shut so that it ties it off with a knot so that it doesn’t allow a blood clot to get out and cause a stroke.  As someone who lives with A-Fib, the possibility of reducing your chances for a stroke can be an answered prayer.

This procedure of using the LARIAT tool to tie off this part of your heart is one that doesn’t require a lot of cuts made into the body and is the reason so many surgeons have started using the tool to do this. The time to heal after having this procedure is quick and you can be back to work within a few days. Using this form of fixing your heart with this tool can be a great alternative to taking blood thinning medication all your life.

The FDA has approved this tool for using it to put stitches in the soft tissue, and for that main purpose, it is safe. However, the area the FDA has not approved it for is the use of tying off this part of the heart muscle, which is what many surgeons have been using this tool for. SentreHeart is said to have plans to start a trial for use in this procedure, but one has not been completed up to this point.

Lariat Suture Delivery Device Side Effects

As with any procedure or medication, there are side effects that can happen. When using this LARIAT Suture Delivery Device tool to tie off this section of your heart, serious side effects have been recorded that have happened and unfortunately, it’s been linked to at least six deaths as well as multiple injuries. It’s been reported that the device has torn deep cuts and made holes in the heart, which in some cases, have caused uncontrollable amounts of bleeding.  Other reports have shown that while doing this procedure with this tool on the heart, what has started out as a simple fix leads to emergency heart surgery.  Many now live with low blood pressure because of this.
The FDA is suggesting to physicians and surgeons that other proven methods and treatment should be used first before trying the LARIAT Suture Delivery Device tool for tying off this piece of the heart.  If this procedure is something you want to pursue, and your physician or surgeon has suggested this, the risks that are associated with this procedure should be fully explained to you and have the discussion as to what are the benefits versus what are the risks with the level of your own personal condition. 

What Do I Do if I’ve Been Injured?

Because there have not been any studies done and the FDA has not approved it for this A-Fib solution, if you or a loved one has been injured because of the LARIAT Suture Delivery Device, you should speak to a lawyer and seek their advice.  Most firms are not seeking a LARIAT device class action against SentreHeart, Inc. at this time but because enough injuries have occurred, they are filing individual claims on behalf of those who have been injured.

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