Apheresis 101: Fresenius Kabi Technology Supports Life-Saving Treatments

man receiving therapeutic apheresis

Kim’s Story: A Life Changed by Apheresis

When Kim Malmstrom began experiencing double vision, her neurologist diagnosed her with myasthenia gravis, a chronic autoimmune disease in which the body mistakenly attacks its own muscles. Over time, medications failed to keep her stable, and one day she suddenly stopped breathing and woke up in the hospital, intubated.

“I remember thinking, please let me wake up...please let me see my kids and husband again,” she said.

Kim began receiving therapeutic apheresis, a treatment that replaces unhealthy blood components with healthy ones.* Blood is drawn from the patient and separated into its components using the Fresenius Kabi Amicus® Separator. 

“Blood enters a centrifuge and spins to separate its components because they have different weights,” said Debbie Ferrell, Senior Manager, Clinical Specialist. “It can then be used in several therapeutic apheresis procedures for chronic and critically ill patients.”

Kim credits therapeutic apheresis as the treatment that worked for her. “It gives me three or four good months, whereas other treatments only lasted a week and then I’d start going downhill,” Today, she enjoys cooking, baking, and pursuing a history degree, supported by her husband and grown children.

Kim’s story is a powerful example of how therapeutic apheresis can change lives. It’s an important story to share on Apheresis Awareness Day, held each year on the third Tuesday in September, with the goal of raising awareness of apheresis medicine.

Understanding Blood Components

To better understand apheresis, it’s worth a quick review of how blood is composed of several components:

  • Plasma: Carries cells and proteins throughout the body
  • Red blood cells: Transport oxygen from the lungs to the body’s tissues
  • Platelets: Play a critical role in blood clotting to stop bleeding
  • White blood cells: Protect against infection and disease 
  • Stem cells: Create new blood components

Apheresis separates these components, allowing clinicians to remove or replace cells that contribute to disease. The Amicus® Separator has supported blood collection since 1997 and is also used in therapeutic apheresis for additional therapeutic procedures.*

How Amicus® Helps Patients

“Our technology is used in different ways depending on the therapeutic apheresis procedure,” said Jeremy McGough, Director Commercial Operations for U.S. Hospitals

  • Therapeutic Plasma Exchange (TPE): Plasma is separated from blood cells and discarded, while the remaining blood cells are mixed with a replacement fluid and returned to the patient, as in Kim’s case.
  • Red Blood Cell Exchange (RBCx): Replaces a patient’s Red Blood Cells (RBCs) and replaces them with healthy donor RBCs.
  • Mononuclear Cell (MNC) Collection: Collection of mononuclear cells while returning other components (RBCs, platelets, plasma) to the donor.
The Provider Perspective: Caring for Patients with Apheresis

For clinicians, performing therapeutic apheresis is about supporting patients through complex treatments and seeing the impact on their lives. Nurses and operators work closely with patients to ensure procedures run smoothly and safely.

“I was very impressed with the team they sent out and the level the trainer was willing to go to make sure everyone was ready to go,” said Laurie Wolf, a registered nurse. Her perspective highlights how thorough preparation and teamwork help providers focus on patient care, ensuring each treatment is as effective and comfortable as possible.

Reliable equipment and support are essential for providers. Fresenius Kabi offers 24/7 technical support and field maintenance through its national network of certified engineers, helping hospital teams address issues promptly and maintain confidence in delivering apheresis procedures.

Ongoing Improvements

The Amicus system and training are continuously refined using customer feedback, said Angela Carlson, Medical Device Engineer. This input helps enhance usability, fine-tune the user manual, and improve the experience for both patients and operators.

“If I or a family member were a patient, I’d want this medical procedure–which can be scary–to be as smooth and comfortable as possible,” she said. “Working towards bettering someone else’s life, that makes my day.”

This commitment underscores the life-changing impact of apheresis. 

“These disorders can happen to anyone, and apheresis may provide a solution,” Ferrell said. “Knowing I’m helping people return to their normal life is what excites me about this work.”

*The testimonial presented is an individual experience and does not guarantee similar results for all patients. Outcomes may vary depending on individual medical conditions, treatment protocols, and other factors. Always consult with your healthcare provider to determine if therapeutic apheresis is appropriate for your specific situation.

Depending on the Amicus Separator System disposable used in the therapeutic apheresis procedure, the Amicus Separator System has been cleared for the following: 

The Amicus Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). The Amicus Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the Amicus separator. The Amicus Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. The Amicus Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the Amicus separator. The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the Amicus separator. The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the Amicus separator. The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. Depending on the Amicus Separator System apheresis kit used in the collection of products, the Amicus Separator System has been cleared to collect: 

  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) 
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double, or triple units) 
  • Red Blood Cells, Leukocytes Reduced (by apheresis) 
  • Mononuclear Cells • Plasma • Fresh Frozen Plasma 
  • Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy. 
  • Plasma Frozen Within 24 Hours After Phlebotomy (PF24) 
  • Must be stored at 1 – 6° C within eight hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy. 
  • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. 
  • Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) 
  • Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy. 
  • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma. 
  • Source Plasma 

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter. Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units). The Amicus platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by the FDA and labeled as a “safety measure”.

The Amicus® Separator System is an automated blood cell separator intended for use in therapeutic apheresis applications and may be used to perform Therapeutic Plasma Exchange (TPE).

The Amicus Separator System is an automated blood cell separator indicated for Therapeutic Plasma Exchange (TPE). The separator can be configured by a qualified service representative to perform TPE procedures if cleared by the appropriate regulatory agency in your country.

Refer to the following patient-related warnings for the Amicus Therapeutic Plasma Exchange Procedure.

  • Procedures involving extracorporeal circulation are associated with the risks of blood loss, hemolysis, air embolism, or blood clotting. To minimize these risks, do not deviate from the procedures described in the Operator’s Manual.
  • Patients with impaired or abnormal citrate or calcium metabolism (i.e., liver and renal diseases) may present an increased risk of citrate sensitivity. For this reason, appropriate assessment and monitoring during apheresis should be prescribed by a physician.
  • Frequent TPE procedures using plasma-poor replacement fluids have been shown to decrease the patient’s protein factors.
  • The physician responsible for the plasma exchange procedure should consider that medications present in circulating blood may be removed with the discarded plasma during a TPE procedure. Modification of dose and schedule may be indicated.
  • Large volumes of biologically derived replacement fluids may increase the frequency and severity of adverse events. Patient should be monitored appropriately.
  • The volume and types of replacement fluids should be determined by the physician responsible for the plasma exchange procedure.

Refer to the Amicus Operator’s Manual and Instructions for Use for the complete list of warnings and precautions associated with the use of these products.