TPE filtration set

TPE Filtration Sets

TPE 1000 and TPE 2000 Pre-connected Sets for Therapeutic Plasma Exchange, powered by the PrisMax and Prismaflex systems.

Therapeutic plasma exchange is associated with positive clinical outcomes1

Therapeutic plasma exchange (TPE) is an extracorporeal blood purification technique used to treat patients with a variety of disorders; it has become a relatively common treatment modality. It is associated with positive clinical outcomes in the treatment of Guillain-Barré syndrome, thrombotic thrombocytopenic purpura (TTP), myasthenia gravis and Goodpasture syndrome.

Compatible Products

CRRT Therapy

Expand beyond CRRT to deliver membrane therapeutic plasma exchange in the ICU

Treatment indications for TPE have increased over time. TPE can be delivered in the ICU using Vantive’s PrisMax and Prismaflex systems, giving clinicians the flexibility to deliver multiple therapies at the bedside anytime, with ease and confidence, in a simple and efficient manner.

Hospitals that already own a PrisMax or Prismaflex device can run TPE without purchasing a new device.2

VantivePhotoshoot_Acute_Day1_2793.jpg

Gain control and flexibility with PrisMax and Prismaflex to deliver multiple therapies at the bedside

Simplicity

Designed for improved ease of use for TPE delivery to enable more time for patient care.

Confidence

Provides enhanced safety features for greater confidence in the delivery of TPE therapy. 

Efficiency

Helps to streamline operations in the ICU when delivering TPE therapy. 

Filtration TPE sets powered by PrisMax and Prismaflex expand treatment options in the ICU

Simplicity and improved ease of use for TPE delivery

Setting up and delivering TPE therapy on the PrisMax and Prismaflex systems is similar to setting up a CRRT procedure,2 which may reduce the amount of additional training required.   

The intuitive user interface of the PrisMax and Prismaflex systems may help to support smooth therapy initiation.2,3

The systems offer the capability for citrate anticoagulation and an integrated syringe pump for heparin anticoagulation.2

Enhanced safety features for greater confidence

The PrisMax and Prismaflex systems offer the ability to delay the start of therapy until the TPE circuit has been filled with blood before initiating treatment.2

The self-regulating pressure system can automatically accommodate blood flow rate adjustments.2

Flow-rate capabilities allow adjustments for lower-body-weight patients.2

Efficiencies to help streamline operations in the ICU

The only additional incremental cost includes the purchase of TPE sets, anticoagulant, replacement solution and procedural disposables,2 allowing for an affordable and predictable treatment cost.4

Around-the-clock critical care support

TPE with the PrisMax System or the Prismaflex System allows clinicians to autonomously support time-critical indications with TPE therapy, 24/7. This can help meet diverse patient needs and the demands of multiple critical care therapies in the ICU.

Vantive offers different TPE filtration sets for plasma protein removal to meet individual patient needs

 

TPE 2000 set

TPE 1000 set

Minimal Patient Weight

Adult

9 kg

Effective Surface Area

0.35 m2

0.15 m2

Blood Volume in Set

 

127 mL

73 mL 

Minimum Blood Flow Rate

100 mL/min

50 mL/min

Maximum Blood Flow Rate

400 mL/min

180 mL/min

Plasmafilter Hollow Fiber

Polypropylene

Polypropylene

Related products

Important Safety Information

PrisMax:

  • The PrisMax control unit is intended for:

Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload.

  • Therapeutic Plasma Exchange (TPE) therapy for patients with diseases where removal of plasma components is indicated.
  • Hemoperfusion (HP) for patients with conditions where immediate removal of substances by adsorption is indicated.

All treatments administered via the PrisMax control unit must be prescribed by a physician.


WARNING!

Use only fluids designed for intravenous operations and are approved for CRRT/TPE/HP usage. Do not use fluids intended for any other usage like enteral feedings/lipids or cytotoxic drugs.


CONTRAINDICATIONS

There are no known absolute contraindications to Continuous Renal Replacement Therapies.

There are no known contraindications to Therapeutic Plasma Exchange.

There are no known contraindications to Hemoperfusion.

Regional Citrate Anticoagulation is contraindicated in patients with severe liver failure and shock with muscle hypoperfusion.

For the following conditions a careful assessment of the individual risk/benefit ratio has to be made by the treating physician (relative contraindications).

  • Inability to establish vascular access.
  • Severe hemodynamic instability.
  • Known hypersensitivity to any component of the Prismaflex disposable set.


TPE Sets:

The Prismaflex TPE1000/TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy (therapeutic plasma exchange).

The Prismaflex TPE1000/TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.

The use of the Prismaflex TPE1000 set should be restricted to patients with a body weight greater than 9kgs (20lbs).

The use of the Prismaflex TPE2000 set should be restricted to adults.

The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment.

The device should be used only on the direction of a physician who has evaluated all of the pertinent features of this device in relation to the individual patient. Patients with bleeding tendencies must be closely supervised during the treatment.

Treatment should be discontinued if acute hemorrhage that can not be corrected (hematemesis, hemoptysis and melena) occurs during TPE.

All treatments administered via the Prismaflex set must be prescribed by a physician.


PRISMAFLEX:

The PRISMAFLEX control unit is intended for:

  • Continuous Renal Replacement Therapy for patients with acute renal failure and/or fluid overload.
  • Therapeutic Plasma Exchange Therapy for patients with diseases where removal of plasma components is indicated.
  • Hemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated.

All treatments administered via the PRISMAFLEX control unit must be prescribed by a physician.
 

Contraindications

There are no known contraindications to Continuous Renal Replacement Therapies.

There are no known contraindications to Therapeutic Plasma Exchange.

There are no known contraindications to Hemoperfusion.

For contraindications that may apply to the disposable set selected for the therapy, refer to the Instructions For Use of the disposable set.

 


For safe and proper use of the devices, please refer to the Instructions for Use.

 

CE 0123

CE 2797

Vantive, Prismaflex and PrisMax are trademarks of Vantive Health LLC or its affiliates.

References

  1. Padmanabhan A, Connelly‐Smith L, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice–evidence‐based approach from the Writing Committee of the American Society for Apheresis: the eighth special issue. J Clin Apher. 2019;34:171-354.  

  2. Vantive Health LLC. PrisMax Operator’s Manual AW8061. 2022.

  3. Broman M, Bell M, Joannes-Boyau O, Ronco C. The novel PrisMax Continuous Renal Replacement Therapy system in a multinational,multicentre pilot setting. Blood Purif. 2018;46:220-227.

  4. Kaplan AA. Why nephrologists should perform therapeutic plasma exchange. Dial and Transplant. 2009;38:65-70.