Arbios Gains IDE for Chronic Liver Disease
Arbios Systems received an investigational device exemption (IDE) from the Food and Drug Administration to conduct a clinical trial with the company’s liver-assist device. The product, SEPET, is designed to treat patients with chronic liver disease. Arbios issued a press release describing the news.
The company already procured conditional approval from the FDA. Additional data was collected through a feasibility trial, which was used to gain the approval to complete the clinical trial with the device.
SEPET is an external liver assist device that provides blood purification. It consists of a disposable, sterile cartridge which contains hollow fibers that are microporous. Patient’s blood is passed through the device and blood plasma are expressed through the micropores. The system is designed to be utilized with standard blood dialysis equipment available in the intensive care setting.
This process cleans the plasma of impurities, such as toxins produced by hepatic failure. When these substances accumulate in a patient’s bloodstream during liver failure, patients can develop hypotension. This accelerates damage to the liver, lung, and other organs, as well as increasing the risk of developing sepsis.
The planned randomized, controlled trial will recruit 116 patients. Patients will be treated with either the SEPET or routine medical care for chronic liver disease with hepatic encephalopathy (HE). The first primary endpoint is the rate of HE resolution, or downgrade of such, within a seven day treatment period. The second primary endpoint of interest is the 30-day transplant free survival rate.An additional 52 patients will be recruited to participate in the trial depending on preliminary results. This phase of the trial will occur if positive results are achieved or results are trending in a positive direction.
May 15, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Surgery, Renal & Urology