HabibTM Endoscopy

HabibTM Endoblate
For Ablation of Tumours in Hollows Organs

HabibTM Endoscopy

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 HabibTM 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 proctoscope during transanal endoscopic microsurgery (TEM). Energy is applied to the targeted gastrointestinal tumour to cauterize and coagulate the tissue.

In multi-center clinical studies, a well demarcated ablation zone was visible after each application of the HabibTM 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.

The HabibTM Endoblate can be used with five alternative 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.

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HabibTM Endoscopy

The HabibTM 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.

TREATMENT OF TUMOURS IN A PATIENT WITH THE HABIBTM ENDOBLATE

Also used for palliation of tumours in Stomach

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HabibTM Endoscopy

ORDERING INFORMATION
HabibTM Endoblate P/N 6000 Specifications 8Fr (2.7mm), Useable Length 170cm 8Fr (2.7mm), Useable Length 200cm FDA Status (class) Cleared Class II CE Status (class) Cleared Class IIb Shelf life 3 years Required accessories Endoscope 3.2mm channel

6100

Cleared Class II

Cleared Class IIb

3 years

Proctoscope 3.2mm channel

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

OTHER EMCISION PRODUCTS

HabibTM Hexablate Ablation of inoperable solid tumours

HabibTM VesCoag For precise vascular occlusion

HabibTM EndoHPB Palliation of biliary and pancreatic tumors

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EMD01 Rev 3