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Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms. Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system. The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm. The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.

The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms. The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system. The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm. The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.

The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667. The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.

The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7 radiopaque markers; 3 in each end 1 in the center. It has a diameter of 6 or 8 mm and the length ranges from 40 to 120mm.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The proposed Niti-S Esophageal Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a rigid, flexible, and expandable tubular device made of a Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes the introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface of the duct to establish patency.