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Gambro’s Theralite Gets HUD Designation From FDA

Gambro has reported that the FDA has granted a HUD (Humanitarian Use Device) designation to its Theralite membrane for the treatment of myeloma kidney in multiple myeloma patients.

The designation is the first step towards obtaining marketing approval in the US. The Theralite High Cut-off technology has been commercially available since 2007 in Europe and was recently granted regulatory approval in Canada.

Multiple myeloma patients with acute kidney failure have traditionally had limited treatment options available to reduce the concentration of free light chains (FLCs) in the blood to allow the kidney to recover function. With the introduction of the Theralite High Cut-off Technology, it is possible to achieve a reduction of FLCs in combination with dialysis treatment. In pilot studies, the kidney function was restored in as many as 70% of the patients participating in the studies.

Carl Kjellstrand, a US nephrologist, said: “The experience from physicians that have treated more than 1400 multiple myeloma patients indicates that renal failure lasting longer than 3 months is almost universally irreversible and quadruples mortality. A treatment removing nephrotoxic Free Light Chains has a great potential for markedly improving both the survival and the quality of life of patients with multiple myeloma.”

Chuck Immel, president of Gambro Ventures, said: “The HUD designation by the FDA is the first step toward bringing this novel therapy to patients affected with this condition in the US In Europe and elsewhere the therapy has shown great potential in preventing the need for ongoing dialysis treatment and improving quality of patient lives.”