endohpb brochure final

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  • 8/6/2019 EndoHPB Brochure Final

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    For the Palliation of Biliaryand Pancreatic Tumours

    HabibTMEndoHPB

    Endoscopy

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    With the ERCP approach a guidewire

    is inserted in the CBD showing

    complete biliary obstruction.

    EndoHPB inserted via the ERCP

    approach over the guidewire.

    Following removal of the EndoHPB

    catheter contrast is seen in the lower

    end of the CBD.

    Metal stent insertion following RF

    ablation of an inoperable tumour in

    the head of pancreas

    The HabibTM EndoHPB

    The HabibTM EndoHPB was cleared by

    FDA 510 (k) to be used to assist in the

    coagulation of tissue during Endoscopic

    surgical procedures in the Gastro-intestinal

    Tract.

    This novel endoscopic bipolar radiofrequency

    (RF) probe has been used for the

    palliation of malignant biliary obstructions

    from cholangiocarcinoma or pancreatic

    adenocarcinoma.

    The RF catheter has been used by

    endoscopists for tumours in the bile duct

    and head of pancreas for partial destruction

    of the tumour prior to stent insertion and for

    clearance of obstructed metal stents.

    The HabibTM EndoHPB is an 8Fr (2.6mm)

    catheter which has a useable length of 180cm

    and two stainless steel ring electrodes at the

    distal tip. It is compatible with endoscopes

    that have a working channel 3.2mm or

    greater. The catheter is introduced over a

    0.035 guidewire into the common bile duct

    (CBD) via the Ampulla of Vater. The catheter

    is manipulated into the CBD where it is used

    to heat and ablate tissue. The electrodes are

    designed to operate at an efcient energy

    level and are activated at 10 Watts for only 90

    seconds before the stent is inserted.

    A recent clinical trial reported in

    Gastrointestinal Endoscopy Journal

    of 22 patients (16 pancreatic, 6

    cholangiocarcinoma) who were treated with

    the EndoHPB catheter between January

    2009 and April 2010. Deployment of the

    catheter was successful in 21 patients. Self

    Expanding Metal Stent (SEMS) placement

    was achieved in all cases of successful

    RFA catheter deployment. One patient

    failed to demonstrate successful biliary

    decompression after SEMS placement

    and died within 90 days. All other patients

    maintained stent patency at 30 days (Steel et

    al GIE 2011;73:149-153).

    The HabibTM EndoHPB can be used with

    the following radiofrequency generators:

    Radionics Cosman Coagulator CC-1, the

    RITA Medical Systems 1500, the RITA

    Medical Systems 1500X, the Conmed 5000,

    the ERBE VIO 200D and the ERBE VIO

    300D.

    Please contact us at [email protected] or

    visit www.emcision.com for more information

    ENDOSCOPIC INSERTION ANDACTIVATION OF THE HABIBTM

    ENDOHPB

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    IMPORTANT

    Prior to use, refer to the Instructions for Use supplied with the

    device for indications, contraindications, adverse effects,

    suggested procedure, warnings, and precautions.

    A 90cm length catheter specically for percutaneous

    use is available to order (ordering information HabibTM

    Percutaneous EndoHPB - Product number 6700).

    PUBLICATION

    Steel AW., et al. Endoscopically applied

    radiofrequency ablation appears to be safe in

    the treatment of malignant biliary obstruction.

    Gastrointestinal Endoscopy 2011;73(1):149-

    153.

    HabibTM Endoblate

    Ablation of tumours in hollow

    organs

    HabibTM VesCoag

    For precise vascular occlusion

    HabibTM Hexablate

    Ablation of inoperable solid

    tumours

    Please contact us at [email protected] or

    visit www.emcision.com for more information

    OTHER EMCISIONPRODUCTS

    6800 8Fr (2.6mm),

    UseableLength 180cm

    Cleared

    Class II

    Cleared

    Class IIb

    3 years Endoscope

    3.2mm channel0.035 guidewire

    HabibTM

    EndoHPB

    P/N Specications FDA Status

    (class)

    CE Status

    (class)

    Shelf life Required

    accessories

    EMD01 Rev 5