Endoblate Brochure

HabibTM Endoblate

For Ablation of Tumours in Hollow Organs

The HabibTM Endoblate is a novel bipolar radiofrequency (RF) probe that is particularly effective for performing endoluminal ablation of gastrointestinal tumours that are not suitable for surgical resection. The Endoblate consists of three contact electrodes and one ring electrode. The electrodes are activated by bipolar radiofrequency energy with no need for grounding pads to be applied to the patient, eliminating the complications that can arise from this. Using endoscopic visualization, the probe is designed to be introduced either through the working channel of an endoscope or through an operating protoscope during transanal endoscopic microsurgery (TEM). Energy is applied to the targeted gastrointestinal tumour to cauterize and coagulate the tissue. The Endoblate can be used with two alternative radiofrequency generators: Radionics Cosman Coagulator CC-1 or the RITA Medical Systems 1500.

In multi-center clinical studies, a well demarcated ablation zone was visible after each application of the Endoblate probe; the probe was then reapplied repeatedly to produce a confluent area of RF ablation on the periphery of the tumour. Histological testing showed that, on average, 82% of the tumour mass was destroyed in the ablation zone. When technically feasible, the ablated tumour can be resected in either open or laparoscopic surgery allowing both immediate assessment of local complications and subsequent histological assessment to be performed. The mean total procedure and ablation time in clinical studies was 40 minutes and 17 minutes, respectively. The average power setting used was 2.7 Watts.

HabibTM Endoblate For Ablation of Tumours in Hollow Organs

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The Endoblate had a very high level of patient acceptability in clinical studies with no evidence of transmural thermal injury, pericolic fluid collection, or bowel perforation. The median length of stay (LOS) after Endoblate therapy followed by resection was 8.4 days and for Endoblate therapy alone was 3.5 days. There were no cases of post-procedure complications related to endoluminal RF ablation, nor were there any recurrent symptoms of bleeding at follow-up clinical assessments.

The HabibTM Endoblate can also be used to stop bleeding and relieve obstruction caused by tumours in the stomach, duodenum and rectum.

PUBLICATIONS Vavra P, Dostalik J, Zacharoulis D, Khorsandi SE, Khan S, Habib NA. Endoscopic radiofrequency ablation in colorectal cancer: Initial clinical results of a new bipolar radiofrequency ablation device. Diseases of the Colon & Rectum 2009. In Press

Khorsandi SE, Zacharoulis D, Vavra P, Navarra G, Kysela P, Habib N. The modern use of radiofrequency energy in surgery, endoscopy and interventional radiology. European Surgery Acta Chirugica Austriaca. In Press


ORDERING INFORMATION

Version SKU Specifications FDA Status (class)

CE Status (class)

Shelf life

Required accessories

Endoblate 6000 7.5F (2.5mm), Useable Length 170cm

Cleared (II)

Cleared (IIb) 6m Endoscope 3.0mm channel

Endoblate XL 6100 7.5F (2.5mm), Useable Length 200cm

Expected Q2 2009

Cleared (IIb) 6m Endoscope 3.0mm channel

PRODUCT IMAGES


IMPORTANT Prior to use, refer to the instructions supplied with these devices for indications, contraindications, adverse effects, suggested procedure, warnings, and precautions.

Hexablate Ablation of inoperable solid tumours

VesCoag Precise vascular occlusion

OTHER EMCISION PRODUCTS

EndoHPB Palliation of biliary and pancreatic tumours

EMD03 Rev 1

Documents

Endoblate Brochure