Baxter Healthcare Corporation has received clearance from the U.S. Food and Drug Administration to market the Accura Hemofiltration System, the company's new instrument that delivers continuous renal replacement (CRRT) and plasma therapies in critical care settings. This system is primarily used for patients suffering from acute renal failure (ARF), however, it is flexible enough to deliver other critical therapies such as Therapeutic Plasma Exchange (TPE), which is used to treat a variety of autoimmune and other serious disorders.
"The Accura system significantly enhances our comprehensive portfolio of products and services for acute renal failure patients, and is also aligned with Baxter's core strength-providing critical therapies for people with life-threatening conditions," said Richard G. Ganz, president of Baxter's Renal business in North America. "This new instrument creates added flexibility for meeting the prescribing needs of physicians caring for a wide range of critically ill patients."
The Accura Hemofiltration System provides great flexibility for prescriptions to be tailored to individual ARF patient needs because the instrument has the capacity to handle a wide range of fluid volumes, from low to high. This extended fluid range is important for addressing rapidly changing circumstances experienced by these critically ill patients. At the same time, the increased fluid capacity means that there may be a less frequent need to exchange solution bags during therapy. This may help reduce the workload of nurses and help improve patient safety by minimizing the number of times a circuit is open and potentially exposed to infection.
The Accura offers a clinician friendly interface and integrated safeguards, including a high definition color screen with step-by-step color diagrams to guide operators, and alarm systems to alert clinicians about system and patient conditions that require their attention.
There are approximately 678,000 patients worldwide with ARF requiring dialysis, 150,000 of whom are in the United States. Traditionally, intermittent hemodialysis (commonly used in a chronic dialysis setting and is administered for three-to-four hours at a time, and may be used every other day to every day depending on patient needs) was used to treat these patients, but continuous therapies are increasingly utilized today. Currently, CRRT is used in 20-25 percent of these cases, and its use is growing at approximately 15 percent each year.
Baxter's comprehensive portfolio for treating acute renal failure patients includes hemofilters, solutions, and a full range of services, including training, education and product support.
Acute renal failure can result from a variety of causes, including hemorrhage, trauma, septic shock, or complicated illnesses and often appears with compromised function of other organ systems. As with chronic kidney failure, some form of renal replacement therapy may be required to prevent life-threatening accumulation of fluids and toxins in the body, which occurs with loss of kidney function. Although ARF may require intensive treatment, unlike chronic kidney failure, the condition usually reverses after the underlying cause(s) has been treated.
Continuous Renal Replacement Therapy (CRRT) encompasses a group of procedures performed in a critical care setting to replace or augment kidney function in an ARF patient. The therapy is performed continuously over a prolonged period of time (24 hours/day for up to 30 days or more in severe cases). During the treatment, the individual's blood is slowly pumped through a filter where excess fluid and wastes are removed from the body. CRRT is an ideal therapy for patients who are hemodynamically unstable (have very low blood pressure brought on by their condition), which is common in this patient population.
Therapeutic Plasma Exchange, which can be performed using the Accura system, is also a method for removing toxic elements from the blood. It is performed by removing blood, separating the plasma from the other blood components, and reinfusing into the patient the non-plasma blood components together with a plasma replacement (typically either albumin or fresh frozen plasma). TPE may be necessary for patients with diseases such as autoimmune disorders, Goodpastures syndrome, Guillain-Barré syndrome, and systemic lupus.