Alsius Receives 510(k) Clearance for Solex Catheter

The FDA granted Alsius 510(k) clearance to market its Solex heat exchange catheter.

The product uses the company’s intravascular temperature management technology, which provides cooling and warming therapy with a computer-controlled temperature regulation system.

The catheter is inserted into a vein in a patient’s neck or leg and circulates saline through balloons. This approach can decrease or increase core temperature from the inside of the body out toward the exterior, allowing for more rapid control of a patient’s core body temperature compared with products such as cooling and warming blankets and ice packs, Alsius said.