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2002 (8) TMI 201

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..... . The impugned order has held that the Stents in question do not fall in the category of accessories for endoscope and for that reason they are not eligible for the exemption. The impugned order has observed as under :- "Endoscopy placement of Stents helps in avoiding traditional surgery. Therefore, it is clear that Endoscopes which are mainly used for diagnosis are also used for placing or stationing Stents at the required place. Therefore, it is clear that at best, Endoscopy can be called as a tool used for the proper placement of Stents and Stents are no way concerned with the functioning of the Endoscopes as such nor are they anywhere associated with the enhancement of the performance level of the Endoscopes nor do they add to the efficacy of the Endoscopes in the strict sense of the term. In other words, while an Endoscope can function without a stent, the stent requires an endoscope to properly place it inside the human system. Therefore, the plea that stent is an accessory of an endoscope is not acceptable. On the other hand, endoscope is a tool used for proper placement of stents". 3. The appellant had relied on the decision of the Apex Court in the case of M/s. Mehra B .....

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..... tip, tubes and suction pumps forceps for removal of biopsy tissue or a foreign body; and electrode tip for cauterization". (emphasis supplied). 5. The appeal also has referred to World News in Digestive Endoscopy Issue 8, April, 1998. This paper describes and states the following about the use of Endoscopic Enteral Metal Stents for Malignant Gastric Outlet Obstruction :- "Surgical gastrojejunostomy is the standard treatment for malignant gastric outlet obstruction (GOO); Unfortunately, this intervention can be associated with significant morbidity and mortality (1). Self-expanding metallic stents designed for the biliary tract, such as the Gianturco-Rosch Z-stent (Wilson-Cook, Inc, Winston-Salem, NC) and the Wallstent (Schneider, Minneapolis, MN) have been reported to provide effective treatment alternatives with minimum morbidity (2-10) but small caliber lumens. Over the past two years, we have used commercially available Wallstent Enteral stents or their prototypes to treat 12 patients who had malignant gastric or duodenal stenoses. Several patients were treated before the stents were approved by the Food Drug Administration for marketing as a gastrointestinal device, but all .....

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..... ry obstruction. Slivka and his colleagues in the Department of Medicine insert metal biliary stents endoscopically, allowing the patient to avoid traditional surgery. The procedure is performed on an outpatient basis under conscious sedation. Metal biliary stents last for six to seven months - twice the service life of plastic biliary stents - eliminating the need for at least one additional procedure and providing greater comfort for patients with malignant bile duct obstruction. Larger metal stents for esophageal obstruction have been in use from the early to mid-1990s, says Dr. Slivka. The newest generation of esophageal stents is inserted alongside an endoscope without dilation, allowing greater comfort for the patient. Plastic-covered esophageal stents have proved particularly effective and safe for patients with tracheo-esophageal fistula resulting from locally advanced disease; the covered stent opens the obstruction and effectively closes the fistula. Endoscopic esophageal stenting is an effective option for malignant dysphagia in patients who are not candidates for surgery. Enteral stents for use in the GI lumen are the most recently approved stents for insertion throu .....

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..... channels in the endoscope for inserting the diagnosis camera and the treatment items. The treatment carried out includes removal of biopsy tissues, or a foreign body, cauterization etc. according to Encyclopaedia and Dictionary of Medicine, Nursing, and Allied Health relied upon by the appellants (quoted in para 3 of this order). Product literature on 3.2 mm Large Channel High Performance Duodenovidescope states that it houses a spacious 3.2 mm instrument channel capable of accommodating an impressive range of therapeutic instruments for procedures including papillotomy, stenting etc. It states that scope exhibits both outstanding therapeutic and superior diagnostic observation capabilities. The paper in world News in Digestive Endoscopy Issue 8, April, 1998 also states that the Stents are deployed during treatment with the help of duodenoscope. It states that stents are placed through the biopsy channel of therapeutic upper endoscopes or duodenoscopes. The article in UPMC Physician April, 1997 Vol. 6, No. 4 states that Technological advancements in the design of expandable metal stents has led to improved endoscopic treatment of GI obstructions. The article states that Endoscopic .....

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..... primary importance." It cannot be disputed that the catheter is an unavoidable adjunct or accompaniment to the haemodyliser. Unless the blood is carried to the haemodyliser for filtration and returned to the patient, in both cases through the catheter, the haemodylisers cannot function. There will be nothing for it to dialyse. To that extent, therefore, the catheter should be considered an adjunct or accompaniment for the convenient use of the haemodyliser. The fact that the Director General Health Services in its opinion dated 24-2-1994 to M/s Intra Medica Exim (P) Ltd., New Delhi has informed it after consulting an expert in nephrology, that catheters of the kind specified in the letter are accessories of haemodyliser lends weight to this conclusion. The goods were therefore entitled to the benefit of the notification". 11. In view of the above, we accept the appellant's contention that the Stents in question are eligible for exemption, as accessories, under Notification No. 17/2001 and the impugned order which has held to the contrary is erroneous. The appeal is accordingly, allowed with consequential relief to the appellants after setting aside the impugned order. - - .....

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