Insertion Facilitator Publication

Presentation at IFSO 2013

Implantation Of The Spatz3 Adjustable Balloon System Without Guidewire And Pusher

E. Machytka 1, Z. Kowalczyk 2, F. Cappelletti 3, S. Walter 4, M. Ekstedt 4, O. Bednarska 4, S. Kechagias 4, E. Mathus-Vliegen 5, C. Lee 6, G. Farfan 7, H. Munnings 8, R. Jirawan 7, G. Marinos 9, V. Puig 10, P. Wolff 11, R. Kosai 12, A. Jasmi 12, J. Mason 13, V. Mehta 14, A. Sood 14, S. Sidhu 14, M. Chhabra 15, J. Brooks 16

University of Ostrava medical faculty Ostrava-Czech Republic 1 Pulsmed hospital surgery Lodz-Poland 2 Valdese Hospital gastroenterology Turin-Italy 3 University Hospital gastroenterology Linkoping-Sweden 4 University of Amsterdam Academic Medical Center Amsterdam- 5 Samsung Medical Center surgery Seoul-Korea, South 6Westshore Medical Centre gastroenterology Cocorite-Trinidad and Tobago 7 Princess Margaret Hospital and Doctors Hospital gastroenterology Nassau-Bahamas 8University of New South Wales gastroenterology Sydney-Australia 9 Hospital Parc Tauli gastroenterology Barcelona-Spain 10 Clinique Kennedy gastroenterology Nîmes-France 11 Malaysia Medical Center gastroenterology Kebangsaan-Malaysia 12 Trafford General Hospital gastroenterology Manchester-United Kingdom 13 Dyanand medical college hospital Gastroenterology Ludhiana-India 14 Fortis Hospital Gastroenterology Mohali-India 15 Sanford Medical Center gastroenterology Fargo-United States 16

 

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Introduction: The Spatz3 Adjustable Balloon utilizes an insertion facilitator for implantation. The facilitator is a tubular silicone sleeve that is fitted on to the end of the endoscope which forms a pocket into which the distal 2 cm of the balloon fits. The endoscope then pulls the balloon passively into the stomach. The balloon comes fitted with a pusher and guidewire which help stabilize the device during the insertion procedure. However, given the stability of the balloon within the insertion facilitator, the pusher and guidewire appeared to be superfluous. Insertion utilizing the insertion facilitator, but without the pusher and guidewire was performed.

Method: Utilizing the aid of the insertion facilitator, 22 endoscopists implanted 35 patients in 12 medical centers with the Spatz3 Adjustable Balloon System without the guidewire and pusher. Upon entry into the antrum the endoscope was retroflexed to confirm position of the balloon below the GE-junction. Following inflation with 200 ml, the endoscope was pulled back to the GE-jct to confirm separation of the balloon from the endoscope. The balloon was then fully inflated to 500 ml.

Results: All 35 devices implanted without difficulty. Patients tolerated the procedure well. Procedure times ranged from 7-10 minutes.

Conclusion: Safe implantation can be performed with the insertion facilitator, without the guidewire and pusher. This can reduce device preparation time and procedure time. The device without guidewire and pusher is less bulky and should diminish patient discomfort