This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Lava Liquid Embolic System
PMA Applicant: BlackSwan Vascular, Inc.
Address: 709 Sandoval Way, Hayward, CA 94544
Approval Date: April 4, 2023
Approval Letter: Approval Order
What is it?
The Lava Liquid Embolic System is used to stop severe bleeding (arterial bleeding or hemorrhage) in the blood vessels of the torso, arms, legs, hands, and feet (peripheral blood vessels). The system also includes particles that can be seen under fluoroscopy imaging when inside the body.
How does it work?
A doctor inserts the delivery catheter in an artery by making a small cut, or incision. The catheter is carefully guided through the blood vessels to the area of arterial bleeding using fluoroscopy imaging. When the liquid embolic is injected into the blood vessel, it forms a spongy solid material that stops active bleeding.
When is it used?
The Lava Liquid Embolic System is used in people who have active arterial bleeding in peripheral vessels. Arterial bleeding, or hemorrhage, can be caused by injury or damage to the organs or blood vessels. Hemorrhage may require emergency medical attention to get bleeding under control.
What will it accomplish?
The Lava Liquid Embolic System becomes solid when injected into a blood vessel to stop active arterial bleeding in peripheral blood vessels. In a study of 113 patients, the system successfully stopped bleeding 94% of the time.
When should it not be used?
The Lava Liquid Embolic System should not be used in pregnant women, babies 4 weeks old or younger (neonates), or people who have problems with liver or kidney function.