How is the I.M.P.A.C.T. System™ different from conventional dialysis?

Blood, as it circulates in the patient, is made up of blood cells, platelets, and a liquid portion of water, proteins and chemical.  We refer to this liquid portion of the blood as plasma. 

Numerous processes add/subtract to/from the plasma as the blood circulates through the body.  Some of these compounds are a result of pathological processes.  These compounds have the potential to cause great harm or death to the patient if not removed.  We refer to these chemical compounds as toxins if they have the ability to cause harm to the patients when they reach excessive levels.  While some of these toxins are soluble (dissolved) in the plasma, a preponderance of the toxins are transported (bound) on proteins carried by the plasma. 

There have been prior attempts to remove toxins from the body.  Dialysis is an extracorporeal system where blood is passed by one side of a semi-permeable membrane with pores (holes) small enough to prevent blood cells, platelets and proteins from passing through.  On the other side of the membrane, is a fresh flow of dialysate (water) containing soluble chemicals (or adsorbent material).  The idea is to allow small soluble toxins to flow from the blood across the membrane (pore size excludes passing of blood cells, platelets and proteins) to be washed away by the dialysate or bound to adsorbent material.  This works well for patients with chronic kidney disease since the toxins in this disease state are both small enough to pass through the pores of the membrane and are dissolved in the water. 

Certain toxins which have now been shown to play a key role in diseases like acute liver failure, sepsis and acute renal failure are mainly bound to plasma proteins.  The challenge has therefore been to remove these protein bound plasma toxins without removing the proteins themselves.

The IMPACT System™ is an extracorporeal method that takes venous blood from the patient, passes it through a plasma separation column (HLM-200) where a portion of the plasma proceeds to a proprietary adsorptive column (HLM-100) to be detoxified while the cellular components are returned to the patient.  A hollow fiber capsule device (HLM-300) is used as an added safety feature to ensure that no particles from the HLM-100 are returned to the patient.  A hemofilter (HLM-400) is included in the IMPACT System kit to remove soluble toxin as well as excess patient water if needed.  The detoxified plasma is returned to the patient.  The IMPACT System™ is driven by a B|Braun Diapact CRRT machine that fully automates the process; a treatment generally lasts four hours. 

Does the I.M.P.A.C.T. System™ alter patient electrolytes?

The I.M.P.A.C.T. System™ adsorption column (HLM-100) uses non-ionic adsorption technology so it does not alter the patient's electrolytes.

Does the I.M.P.A.C.T. System™ remove both soluble and bound toxins?

The I.M.P.A.C.T. System™ removes both soluble and bound toxins in the adsorption column (HLM-100). In addition, a hemofilter (HLM-400) may also be added to the system for removal of soluble toxins and excess patient fluid if needed.

How long is a typical treatment with the I.M.P.A.C.T. System™?

Each treatment is 4 hours and may be repeated on subsequent days if needed.

Is systemic anticoagulation required during an I.M.P.A.C.T. System™ treatment?

Yes. Systemic heparinization is used during the I.M.P.A.C.T. System™ treatment. Activated Clotting Time (ACT) levels are similar to those typically used during Acute Renal Failure and Apheresis treatments.

Is the I.M.P.A.C.T. System™approved for use by the FDA?

The I.M.P.A.C.T. System™is currently being studied in clinical trials under an approved IDE. Data from the ongoing clinical trials will be submitted to the FDA upon completion of the studies.

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