FDA Approves Cholesterol-Lowering Device

Kaneka America Corp has been given the go-ahead by the US Food and Drug Administration to offer a medical device to lower cholesterol to a small group of people who, because of a genetic disorder, have extremely high cholesterol levels and are at very high risk of heart disease or heart attacks early in life. An estimated 4,000 people in the USA are in this category.

The device, called the Liposorber LA-15 System, is a filtering system that removes low density lipoprotein from the blood via a process similar to kidney dialysis. The procedure takes about three hours, is done at a medical facility, and must be repeated every one to two weeks indefinitely.

The agency's decision to approve the device was based on a review of safety and effectiveness data from a study submitted by the manufacturer in which 74 patients were treated with the device at 11 US sites. The patients were on cholesterol-lowering drugs and diet, but these had little effect on their cholesterol levels.