brochure endohpb emd01 rev 5
TRANSCRIPT
For the Palliation of Biliary and Pancreatic Tumours
HabibTM EndoHPB
Endoscopy
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 efficient 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 AND ACTIVATION OF THE HABIBTM
ENDOHPB
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 specifically for percutaneous use is available to order (ordering information HabibTM Percutaneous EndoHPB - Product number 6700).
PUBLICATIONSteel 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 VesCoagFor 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 EMCISION PRODUCTS
6800 8Fr (2.6mm),
Useable
Length 180cm
Cleared
Class II
Cleared
Class IIb
3 years Endoscope
3.2mm channel
0.035” guidewire
HabibTM EndoHPB
P/N Specifications FDA Status (class)
CE Status (class)
Shelf life Required accessories
EMD01 Rev 5