INNOVANCE PFA-200 System¹
Fast and reliable platelet dysfunction detection

INNOVANCE PFA-200 System

The INNOVANCE^® PFA-200 System¹ provides automated assessment for inherited, acquired, or drug-induced platelet dysfunction. It measures the process of primary hemostasis and aids in the rapid detection of platelet dysfunction. Through flow technology, the system provides a realistic hemodynamic environment for the measurement of primary hemostasis.

Screens platelet function in patients with impaired primary hemostasis, such as von Willebrand disease²
Provides excellent sensitivity for congenital platelet dysfunction, such as Glanzmann thrombasthenia
Verifies efficacy of desmopressin acetate (DDAVP) therapy in presurgical patients³
Assesses platelet dysfunction caused by aspirin
Evaluates platelet dysfunction in multiple clinical settings, such as presurgical screening, high-risk pregnancy and menorrhagia
Detects platelet P2Y12-receptor blockades in patients undergoing therapy with P2Y12-receptor antagonists

Features & Benefits

Simple, rapid, qualitative, and precise automated assessment of platelet function

The INNOVANCE^®PFA-200 System¹ provides simple, rapid, qualitative, and precise automated assessment of platelet function and supports clinically relevant decision-making processes effecting therapies. The system quickly measures platelet plug formation in a small whole blood sample (800 μL) and reports a ”closure time” in 5-8 minutes.

Comprehensive bleeding risk assessment

The INNOVANCE PFA-200 System’s unique technology simulates in vitro hemodynamic conditions of platelet adhesion and aggregation in a vascular lesion, providing rapid detection of acquired, inherited, or drug-induced platelet dysfunction in multiple clinical settings. Combining the INNOVANCE PFA^® P2Y test¹, the Dade^® PFA Collagen/EPI Test Cartridge, and the Dade PFA Collagen/ADP Test Cartridge provides a comprehensive, cost-effective preoperative bleeding risk solution.

Simple 3-step process requires minimal pipetting and hands-on time
Results from one 800 μL sample of blood
One cut-off for P2Y samples in 3.2 and 3.8% buffered sodium
Preoperative screening results in 5-8 minutes

Detects inherited, acquired, and drug-induced platelet dysfunction

In combination with traditional coagulation screening tests such as prothrombin time and activated partial thromboplastin time, the INNOVANCE PFA-200 System provides excellent sensitivity to functional defects of hemostasis.

Accurate detection of acquired, inherited, or drug-induced platelet dysfunction under high-shear stress
Sensitive to quantitative and qualitative abnormalities of VWD in both plasma and platelets
Simple, rapid, semi-quantitative, and precise assessment of platelet function
Software supports closure curve⁴ illustrations for use in scientific studies

Reliable detection of aspirin-induced platelet dysfunction

The INNOVANCE PFA-200 System assesses whether doses are sufficient to induce platelet dysfunction. While other analyzers only detect the inhibition of platelet aggregation, the INNOVANCE PFA-200 System accurately measures the ability of aspirin to prevent platelet plug formation.

Effective monitoring of pre-surgical therapy

Several “screening tests” fail to detect a number of mild bleeding disorders that could cause substantial bleeding. The INNOVANCE PFA-200 System, however, can reliably identify patients with a bleeding risk due to platelet function deficiency. With the INNOVANCE PFA-200 System, most patients with prolonged Col/ADP Closure Times manifest abnormalities in primary hemostasis that could place them at risk during surgery.

The Dade PFA Collagen/EPI Test Cartridge provides effective assessment of pre-surgical therapy with desmopressin (DDAVP)
Several clinical studies suggest that the PFA closure time (CT) with both the Dade PFA Collagen/EPI and Dade PFA Collagen/ADP Test Cartridges becomes measurably shorter following infusion of DDAVP
Shorter closure times indicate improved platelet function and may indicate improvement in bleeding symptoms and transfusion needs

Safe and efficient testing

No special sample collection requirements–only a small volume of citrated whole blood is needed (800 μL)
All PFA tests can be run from one patient sample tube
All biological material remains in the test cartridge. This feature minimizes operator/blood contact for improved safety and consistency, avoiding instrument contamination and facilitating safe biohazard disposal
Blood samples are stable for up to 4 hours after collection
Built-in quality control program reduces risk of reporting false results
Password/access levels protect sensitive patient data and provide enhanced traceability records

Assays

Dade^® PFA Collagen/EPI Test Cartridge
Dade PFA Collagen/ADP Test Cartridge
INNOVANCE^® PFA P2Y¹

Technical Specifications

Dimensions	37.3 cm x 25.6 cm x 37.4 cm (W x D x H)
Weight	10.0 kg

Principle	High-shear force dynamic flow system
Measuring channel	Single measuring channel
Incubation category	Two incubation wells
Incubation temperature	37.9 °C ± 1.0 °C
Incubation warm up-time	< 15 minutes (room to operating temperature)
Trigger solution	Illuminated trigger solution viewing area
Sample Handling:
Type of sample	Citrated whole blood
Sample mechanism	Manual pipette dispensing (800 μL)
Bar-code identification	Optional external bar-code reader for sample identification
Reagent Handling:
Type	Single disposable self-contained test cartridge
Reagent recognition	Positive optical-coding reagent cartridge identification
Additional reagent	Trigger solution
Throughput:
Single test	Dade PFA Collagen/EPI Test Cartridge, Dade PFA Collagen/ADP Test Cartridge, or INNOVANCE® PFA P2Y1: 6 tests/hour
Duplicate test	Dade PFA Collagen/EPI Test Cartridge, Dade PFA Collagen/ADP Test Cartridge, or INNOVANCE PFA P2Y1: 10 tests/hour
Software:
Interface	Color LCD touchscreen
Host connection	Uni-directional, external RS-232 DB-9 port or ethernet network
Sample ID	Maximum 20 numeric characters
Stored patient results, control results, and maintenance events	Last 1,200 results
Software update	USB flash drive
USB port	Software updates, printer, barcode scanner, and result export
Closure curve⁴	Displayed on screen, printed as PDF, and exported to USB memory stick
Quality control	Built-in
Password/access levels	Yes
Onboard help	Yes
Instrumentation status	Clear status messages (red, yellow, and green)
Computer/Printer
Workstation	Built-in PC
Display	Display
Display	Built-in 24 character-wide thermal printer, sound level printing 47 dB(A)
Printer paper	61.9 mm wide thermal paper roll with standard 5-year readable life

Services & Support

Education & Training

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¹ Not available for sale in the U.S. Product availability varies by country.

²Koscielny J, Ziemer S, Radtke H, et al. A practical concept for preoperative identification of patients with impaired primary hemostasis. Clin Appl Thromb Hemost. 2004;10:195-204.

³Koscielny J, von Tempelhoff GF, Ziemer S, et al. A practical concept for preoperative management of patients with impaired primary hemostasis. Clin Appl Thromb Hemost. 2004;10:155-66.

⁴For research use only. Not for use in diagnostic procedures

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.