Delcath Hepatic Chemosat Delivery System; Description Of System Components - Delcath Systems CHEMOSTAT Mode D'emploi

DELCATH HEPATIC CHEMOSAT
DELIVERY SYSTEM
Do not attempt to use the device before completely reading and
understanding the instructions for use. Please contact Delcath Customer
Service at +353 91 746200 with any questions or complaints.

DESCRIPTION OF SYSTEM COMPONENTS

The Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT System) consists of a
closed circuit of catheters and drug specific filters utilized to deliver a chemotherapeutic
agent (melphalan hydrochloride) to the (hepatic) artery of the liver and to lower the
concentration of the agent in the blood before it is returned to systemic circulation. A
schematic overview of how the Delcath CHEMOSAT System components work together
is presented in Figure 1: Assembled System. The system is designed to be used with
a Medtronic Bio-Medicus 560, 550 or 540 Bio-Console and TX50P or TX40P Flow
Transducer.
1. Delcath Isofuse® Isolation Aspiration Catheter -- The Isofuse Catheter is
a 16F, polyurethane double balloon catheter, that is placed in the retro-hepatic
inferior vena cava to isolate the hepatic venous blood and transport it to the
Hemofiltration (Chemofiltration) Circuit for filtration. The catheter has one large
drainage lumen and three accessory ports. Due to variation in the length of the
retro-hepatic segment of the inferior vena cava and relative positions of hepatic and
renal veins, the Isofuse Catheter is available in two different balloon configurations:
50 mm or 62 mm between the two balloons.
Using pre-operative computed tomography (CT) imaging, or by performing an
inferior vena cavogram prior to placement of Isofuse Catheter, the length of the
retro-hepatic segment of the inferior vena cava and the relative positions of hepatic
and renal veins should be estimated in order to determine the optimum Isofuse
Catheter balloon spacing: 50 mm or 62 mm.
Two (2) of the accessory ports are used to inflate low-pressure occlusion balloons,
which are inflated independently to occlude the inferior vena cava above and
below the hepatic veins. When inflated, the cephalic (superior - blue port) balloon
obstructs the inferior vena cava above the hepatic veins and the caudal (inferior -
yellow port) balloon obstructs the inferior vena cava below the hepatic veins, thus
isolating hepatic venous blood in the fenestrated segment between the balloons.
The large drainage lumen is a conduit to the fenestrations between the two
occlusion balloons. These allow the hepatic venous blood to flow into the drainage
lumen and exit the catheter at the proximal end. The third accessory (translucent)
port is designed to sample hepatic venous blood from the large drainage lumen and
to inject iodinated contrast medium through the fenestrations, to check catheter
position.
The fourth accessory port (white) is designed to be used for over-the-guidewire
(OTW) introduction and positioning of the catheter in the retro-hepatic inferior vena
cava. Additionally, this lumen also has a small port opening along the catheter shaft
positioned inferior to the caudal balloon and exits at the distal tip, to allow inferior
vena cava blood, proximal to the caudal balloon, to bypass the occluded segment of
the inferior vena cava and flow into the right atrium.
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2. Accessory Pack
• 8 -10F and 12-14F Stepped Dilator Set -- These over-the-wire dilators are
used to widen the subcutaneous space and venous entry site in preparation
for the placement of the 18F Introducer Set.
• 1 8F Introducer and Dilator -- The 18F introducer sheath and coaxial dilator are
to be placed over a wire; the dilator is removed and the sheath is available for
the insertion of the Isofuse Catheter or the 18F Obturator.
• 1 8F Obturator -- An 18F obturator is used to occlude and support the 18F
sheath lumen when it is not in use, and upon removal of the Isofuse Catheter
at the end of the procedure.
• 5 F Introducer Set ("Introducer Sheath") -- A 5F hemostatis sheath is used
to facilitate the introduction of the 5F Chemofuse Chemo Delivery catheter
through the femoral artery.
• 1 0F Introducer Set ("Venous Return Sheath") -- A 10F sheath used to return
the filtered hepatic venous blood through the internal jugular vein. A 3-way
high-flow stopcock is included as part of the 10F Introducer Set. The high-
flow stopcock is attached to the Venous Return Sheath and then to the male
connector of the Hemofiltration Circuit, if required. This sheath may also be
used for hydration.
3. 5F Chemofuse® Chemo Delivery Catheter -- 5F arterial catheter used to
deliver chemotherapeutic agent (melphalan hydrochloride) into the proper
hepatic artery or, if required, it can be used to coaxially introduce a microcatheter
(not provided by Delcath) for selective tip placement.
4. Delcath Hemofiltration (Chemofiltration)Dual Filter Cartridge
(Chemofilter) -- One single-use Dual Filter Cartridge designed with the filter
cartridges arranged in parallel to lower the concentration of chemotherapeutic
agent (melphalan hydrochloride) from the blood. The cartridge frame comes
with a built-in pole clamp to facilitate IV pole mounting.
5. Hemofiltration (Chemofiltration) Circuit ("Extracorporeal Circuit") -- The
Hemofiltration (Chemofiltration) Circuit is used to transport the hepatic venous
blood, which has been isolated by the Isofuse Catheter and aspirated into the
fenestrated lumens, through the Hemofiltration (Chemofiltration) Cartridges and
back to the patient through the Venous Return Sheath. Connections are provided
for infusion of saline. This circuit includes:
• M edtronic Bio-Medicus BP50 Bio-Pump Centrifugal Pump ("Pump Head"),
a disposable pump head to be used with a pump console manufactured by
Medtronic Bio-Medicus, Inc. - see manufacturer's Instructions for Use for
Pump Head. (Note: The Medtronic Bio-Medicus 560, 550 or the 540 Bio-
Console Drive Unit is required for use with the Delcath Hepatic CHEMOSAT
Delivery System: This is NOT PROVIDED by Delcath).
• T he Medtronic Bio-Medicus DP38P Bio-Probe Flow Probe ("Flow Probe"), a
disposable flow probe to be used with a flow transducer manufactured by
Medtronic Bio-Medicus, Inc. - see manufacturer's Instructions for Use for Flow
Probe (Note: The Medtronic Bio-Medicus TX50P or the TX40P Flow Transducer
is required for use with the Delcath Hepatic CHEMOSAT Delivery System: This
is NOT PROVIDED by Delcath).
6. Carbon Dioxide (CO ) Connection Line -- The CO
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to deliver sterile CO gas to the Hemofiltration Cartridges to aid in priming/
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debubbling the filter cartridge with saline, prior to the start of the procedure. The
CO Line has no patient contact.
2
5
Connection Line is used
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