FDA Approves Machine to Filter Cholesterol From Blood
Feb. 23, 1996
WASHINGTON (AP) _ Patients with severely high cholesterol who aren't helped by low-fat diets or drugs now have a new option: getting the fat literally filtered out of their blood.
The Food and Drug Administration on Thursday approved the Liposorber, a machine that cleanses the blood of cholesterol much like dialysis removes toxins from a kidney patient's body.
The Liposorber is only for people with very high cholesterol who aren't helped by a low-fat diet or medicine, the FDA warned. This condition, called severe hypercholesterolemia, affects about 4,000 Americans.
The treatment could be a lifesaver for certain patients, said Dr. Evan Stein of the Cholesterol Treatment Center in Cincinnati.
``It's gone pretty well,'' said Frank Bialek of Pittsburgh, who has been in a clinical trial of the machine since 1990, when he had a heart attack at age 31.
Regular Liposorber treatments have helped his arteries become relatively free of clogs, he said. ``Other than the inconvenience of laying still for four or so hours, it's not all that bad.''
Made by Kaneka America Corp. of New York, the treatment starts with doctors inserting small tubes into both of a patient's arms. The patient's blood, slowly and a little at a time, runs from one tube into a machine that separates the plasma from other blood cells. Then the Liposorber, a column inside the machine, binds up low-density lipoprotein, or LDL, cholesterol in the plasma.
The patient can watch this so-called bad cholesterol, a yellow-looking gunk, accumulate inside the machine as the cleansed plasma then is mixed back into blood cells. The filtered blood then flows back into the patient's other arm, missing nothing except the fat.
The treatment takes between three and four hours, and tests of 74 patients showed it can remove 73 percent to 83 percent of the LDL cholesterol in the patient's blood. Most patients started with an average cholesterol level of 400, which the Liposorber dropped to 120.
LDL is the type of cholesterol that causes plaque to build up inside arteries, leading to heart attacks. The Liposorber does not remove the so-called good cholesterol, the high-density lipoprotein or HDL type.
But the machine is not a cure, the FDA warned. The cholesterol levels crept back up within about 14 days, meaning patients will have to undergo this treatment every two or three weeks indefinitely.
``It's invasive. It's time-consuming,'' Stein said. ``It's not cheap. ... It's not something I'd put my patients on tomorrow unless they really needed it.''
Kaneka said the Liposorber equipment will cost $1,200 per treatment, but Stein said the total charges to patients, who have to be monitored by a nurse, will be between $1,500 and $2,000 every two weeks.