Hepashpere
Features & Benefits

HepaSphere Microspheres are calibrated, spherical, hydrophilic microspheres made from 2 monomers (vinyl acetate and methyl acrylate) that combine to form a copolymer (sodium acrylate alcohol copolymer). This proprietary design allows a more complete and targeted occlusion of the blood vessels with or without delivery of doxorubicin HCl for therapeutic or preoperative purposes in the following procedures:

• Embolisation of hepatocellular carcinoma

• Embolisation of metastases to the liver

HepaSphere Microspheres’ unique properties offer the following advantages:

• Targeted: Flow directed due to spherical shape.

• Absorbing: Rapidly absorbs aqueous solutions such as contrast media, saline, or reconstituted doxorubicin HCI*.

• Conforming: Compresses in the vessel lumen, providing more surface contact with vessel intima.

• Expanding: Expands up to four times the stated dry diameter when hydrated.

* Doxorubicin HCl used with HepaSphere Microspheres should be reconstituted with saline, never use pure water.

Regulatory Information

USA

HepaSphere Microspheres are not approved or available for sale in the United States.

Canada

HepaSphere Microspheres without doxorubicin HCl loaded (bland) are indicated for use in embolisation of blood vessels for therapeutic or preoperative purposes in the following procedures:

• Embolisation of hepatocellular carcinoma

• Embolisation of metastases to the liver

HepaSphere Microspheres loaded with doxorubicin HCl are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in:

• Embolisation of unresectable hepatocellular carcinoma

European Union

HepaSphere™ Microspheres without drug loading (bland) are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in the following procedures:

• Embolization of hepatocellular carcinoma,

• Embolization of metastases to the liver.

HepaSphere Microspheres loaded with doxorubicin HCl are indicated for use in embolization of blood vessels for therapeutic or preoperative purposes in:

• Embolization of unresectable hepatocellular carcinoma.

HepaSphere Microspheres loaded with irinotecan are indicated for use in:

• Embolization of metastatic colorectal cancer (mCRC) to the liver.

For all other locations, please contact your local Merit Medical representative.

For full prescribing information please refer to the HepaSphere Microspheres Instructions for Use.

Documents
Ordering Information

Catalog NumberVolumeColorExpanding RangeCarrier Solution
  V225HS25 mgOrange120-240 µmDry
More Attributes
Delivery SystemVial
Expanded Family NameHepaSphere™ Microspheres
Size Range30-60 µm
Delivery System Size10 mL
GS111135
GTIN Unit00884450111352
GTIN Carton10884450111359
GTIN Shipper20884450111356
HCPCS Code
  V250HS50 mgOrange120-240 µmDry
More Attributes
Delivery SystemVial
Expanded Family NameHepaSphere™ Microspheres
Size Range30-60 µm
Delivery System Size10 mL
GS122861
GTIN Unit00884450228616
GTIN Carton10884450228613
GTIN Shipper20884450228610
HCPCS CodeNo Applicable code
  V325HS25 mgYellow200-400 µmDry
More Attributes
Delivery SystemVial
Expanded Family NameHepaSphere™ Microspheres
Size Range50-100 µm
Delivery System Size10 mL
GS108921
GTIN Unit00884450089217
GTIN Carton10884450089214
GTIN Shipper20884450089211
HCPCS Code
  V525HS25 mgBlue400-600 µmDry
More Attributes
Delivery SystemVial
Expanded Family NameHepaSphere™ Microspheres
Size Range100-150 µm
Delivery System Size10 mL
GS110273
GTIN Unit00884450102732
GTIN Carton10884450102739
GTIN Shipper20884450102736
HCPCS Code
  V725HS25 mgRed600-800 µmDry
More Attributes
Delivery SystemVial
Expanded Family NameHepaSphere™ Microspheres
Size Range150-200 µm
Delivery System Size10 mL
GS109755
GTIN Unit00884450097557
GTIN Carton10884450097554
GTIN Shipper20884450097551
HCPCS Code

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