The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of removal have failed.
Under the BDD program, the FDA will provide Philips with priority review and interactive communication regarding device development throughout the submission process.
The approval is based on recent research that supports the technology as two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99% effective with a major adverse event rate of 0.7-2%.
An inferior vena cava (IVC) filter is a small device that can stop blood clots from going up into the lungs. The inferior vena cava is a large vein in the middle of your body. This device is put in during a short surgery.
Veins are the blood vessels that bring oxygen-poor blood and waste products back to the heart. Arteries are the blood vessels that bring oxygen-rich blood and nutrients to the body.
A deep vein thrombosis (DVT) is a blood clot that forms in a vein deep inside the body. A clot occurs when blood thickens and clumps together. In most cases, this clot forms inside one of the deep veins of the thigh or lower leg.
The veins in ones legs have tiny valves that help keep blood moving back up toward the heart. But a DVT may damage one or more of these valves.
This causes them to weaken or become leaky. When this happens, blood starts to pool into the legs and can also happen if one is immobile for a long period of time.
Normally, muscles in the leg help blood move up in the veins when the muscles contract. When blood flows very slowly through the veins, this increases the risk that cells in the blood will stick together and form a clot.
DVT is a serious medical condition that can cause swelling, pain, and tenderness in the leg. In some cases, a deep clot in a leg vein can break free and stick in a vessel in the lung.
This can cause a blockage in the vessel called a pulmonary embolism. Pulmonary embolism can cause severe shortness of breath and even sudden death.
An IVC filter is one method to help prevent pulmonary embolism. The inferior vena cava (IVC) is the major vein that brings oxygen-poor blood from the lower body back to the heart.
The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.
Failure rate for IVC filter removal is high and limited options for removal exist if the filter has become difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature.
Physicians have very few tools to remove the filter when this happens and there are no FDA-approved devices for this type of advanced removal.
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