Indications For Use; Contraindications; Warnings - Delcath Systems CHEMOSTAT Mode D'emploi

WARNING
Only the Components Provided in the Hepatic Delivery System Are to Be
Used to Create the Circuit. There Should Be No Substitutions. The Circuit
Has Not Been Validated For Use With Non-Delcath Components.
NOT INCLUDED:
• H eparin
• C ryoprecipitate
• N ormal Saline
• P rotamine Sulfate
• C hemotherapeutic agent (melphalan hydrochloride)
• B ubble Trap holder
• T wo (2) Pressure Displays
• M edtronic Bio-Medicus 560, 550 or 540 Bio-Console ("Pump")
• M edtronic Bio-Medicus TX50P or TX40P Flow Transducer
• C O Supply for Priming Dual Filter
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• D rug Injector: Angiographic or CT Injector (such as Medrad Mark V ProVis)
– must be able to inject at a rate of 25 mL/minute
• D rug Delivery Disposables:
• O ne (1) Medrad 150mL Syringe (Polypropylene (PP)-Barrel &
Polyisoprene-Plunger) or equivalent
• T wo (2) Intravenous Administration Set with spike & drip
chamber (Polyvinylchloride (PVC)-tubing, Acrylonitrile
butadiene styrene (ABS) & Polyethylene (PE)-Drip Chamber &
Polycarbonate (PC)-Luer) or equivalent
• O ne (1) - 48" injector lines (PVC-Tubing & PC-Luer) or
equivalent
• F ive (5) 3-way stopcocks (PC-body, High Density Polyethylene
(HDPE) or Acetal-Handles) or equivalent
• T hree (3) 20 mL syringes (PP-Barrel & Polyisoprene-Plunger) or
equivalent
• M icro Catheters (2.8F maximum) – for Selective Drug Infusion:
• M erit Maestro (Merit Medical Systems, Inc., So. Jordan, UT, USA)
• B SC Renegade Hi-Flo (Boston-Scientific Corp.; Natick, MA, USA)
• T erumo Progreat (Terumo Medical Corp., Somerset, NJ, USA)

INDICATIONS FOR USE

The Delcath Hepatic CHEMOSAT Delivery System is used for percutaneous intra-arterial
administration of chemotherapeutic agent (melphalan hydrochloride) to the liver with
subsequent extracorporeal filtration of the regional (hepatic) venous blood, lowering the
concentration of chemotherapeutic agent in the blood before returning it to the systemic
venous circulation.

CONTRAINDICATIONS

• L iver failure or portal hypertension.
• A ctive intracranial metastases or brain lesions with a propensity to bleed as
determined by imaging.
• H istory of allergies or known hypersensitivity to a component, material, or drug
utilized with the CHEMOSAT System including:
- Heparin
- Angiographic contrast medium
- Natural rubber latex component of the product
- Melphalan hydrochloride

WARNINGS

PLEASE CAREFULLY READ AND UNDERSTAND THE LIST OF
WARNINGS BELOW AS SERIOUS INJURY, ILLNESS OR DEATH
OF THE PATIENT CAN OCCUR IF THESE WARNINGS ARE NOT
PROPERLY FOLLOWED
• T he CHEMOSAT System must not be used in patients who have undergone
surgery or medical treatment of the liver within 4 weeks.
• S creen for prior surgeries that could potentially affect normal hepatic biliary/
vascular anatomy (e.g., Whipples Procedure). If the common bile duct is re-
implanted, there is an increased risk of biliary tree infection. If the vascular
anatomy (especially hepatic arterial supply) is affected, there could be an
increased risk of mis-infusion and reflux of chemotherapeutic agent.
• F or patients with 50% or greater tumor burden by medical imaging, a biopsy of
the non-involved parenchyma must be performed to show that it is histologically
normal. Clinical judgment and biopsy results should be used to guide the decision
on whether to perform the procedure.
• P atients on chronic anti-coagulation therapy (e.g., Coumadin ), the therapy
must be discontinued and switched to short- acting agent for the ease of
reversal. Patients should avoid drugs effecting platelet functions such as aspirin,
or non steroidal anti-inflammatory drugs (NSAID), starting one week before
the procedure. Anti-coagulation therapy may be resumed post-operatively, as
indicated, once hemostasis has been restored and no bleeding complication is
observed.
• P atients with a history of hypertension receiving angiotensin converting enzyme
inhibitors or calcium channel blockers must temporarily discontinue these drugs
at least five drug half-lives before the procedure. Short-acting antihypertensive
regimen may be used to manage hypertension as needed. After the procedure,
previous antihypertensive regimen may be restored under guidance of treating
physicians.
• W hen the catheter is placed intravascularly, it must only be manipulated under
fluoroscopic observation. Do not advance or retract the Isofuse Catheter unless
both balloons are fully deflated, except when positioning the inflated cephalad
balloon at the junction of the inferior vena cava and right atrium (with the caudal
balloon fully deflated). If resistance is met during manipulation, determine the
cause of the resistance before proceeding.
• W hen the 3-way high flow stopcock is used to attach the Venous Return Sheath
to the male connector of the Hemofiltration Circuit, ensure that the handle is
centered over the side female luer port to minimize back pressure and maximize
flow through the stopcock.
• U se caution to avoid air embolism while performing this procedure. Never use air
or any gaseous medium to inflate the Isofuse Catheter balloons.
• C ontents are supplied STERILE. Inspect prior to use to verify that no damage has
occurred during shipping. Do not use if sterile barrier is damaged. If damage is
found, please contact Delcath Customer Service.
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