Iliac artery stent; Multiple Peripheral artery stent, bare metal; Trachea prosthesis; Bare Metal Biliary stent; Bare Metal Bronchial stent - India CDSCO Medical Device Registration

Product Information

Iliac Artery The WALLSTENT-Uni Endoprosthesis is indicated for use following suboptimal percutaneous transluminal angioplasty (Hot Axios Stent and Electrocautery-Enhanced Delivery System) of common and/or external iliac artery stenotic lesions, which are less than or equals to 10 cm in length. A suboptimal PTA is defined as a technically successful dilation, judged by the physician to be suboptimal due to the presence of unfavorable lesion morphology such as: * An inadequate angiographic and/or hemodynamic result as defined by a 30 percentage or greater residual stenosis after PTA, lesion recoil, or intimal flaps. * Flow limiting dissections post PTA longer than the initial lesion length. * A 5 mm Hg or greater mean transtenotic pressure gradient post PTA. Superficial Femoral Artery The WALLSTENT-Uni Endoprosthesis is intended for use in the treatment of superficial femoral artery (Hot Axios Stent and Electrocautery-Enhanced Delivery System) stenoses or occlusions. Transjugular Intrahepatic Portosystemic Shunt (Hot Axios Stent and Electrocautery-Enhanced Delivery System) The WALLSTENT-Uni Endoprosthesis is indicated for creation of transjugular intrahepatic shunt connections between the portal venous system and the hepatic vein for prophylaxis of variceal bleeding or intractable ascites in the treatment of portal hypertension and its complications in patients who have previously failed conventional treatment techniques. Biliary The WALLSTENT-Uni Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. Tracheobronchial The WALLSTENT-Uni Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Central Venous The WALLSTENT-Uni Endoprosthesis is indicated for the treatment of central venous obstruction and for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis greater than or equals to 30 percentage for a vein less than or equals to 10 mm in diameter or greater than or equals to 50 percentage for a vein greater than 10 mm in diameter, a tear which interrupts the integrity of the intima lumen, abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the WALLSTENT-Uni Endoprosthesis are the innominate and subclavian veins, ranging from 8 mm to 15 mm in diameter. Superior Vena Cava (Hot Axios Stent and Electrocautery-Enhanced Delivery System) The WALLSTENT-Uni Endoprosthesis is intended for use in the palliative treatment of stenosis of the superior vena cava due to a malignant process. Iliac Vein The WALLSTENT-Uni Endoprosthesis is intended for use in the iliac veins for the treatment of symptomatic venous obstruction