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The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for: - Intermittent drainage of symptomatic, recurrent, malignant ascites that does not ● respond to medical management of the underlying disease - Palliation of symptoms related to recurrent malignant ascites ● - Peritoneal placement only ● The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.

The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.

The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease. The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.

The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.

The Denver Pleural Effusion Shunt is indicated for use in patients with chylothorax, intractable aseptic pleural effusion. The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with: chylothorax, intractable pleural effusion.

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components: 1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff. 2. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum. 3. A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cavity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber. Except for the polyester cuff, all components of the shunt are made of silicone rubber.

Peritoneo-venous shunting is indicated for patients with: - chronic liver disease whose ascites has not responded to surgical correction of their underlying disease and to medical management. - persistent ascites who are not considered candidates for portal-venous shunting. - persistent ascites that is non-responsive to standard medical management. - peritoneal intra-abdominal neoplasms with massive ascites to help relieve abdominal distension and intra-abdominal pressure. Peritoneo-venous shunting should also be considered for patients with hepatorenal syndrome and idiopathic ascites.

The Denver Ascites shunt is made of a fenestrated peritoneal catheter, which collects the ascites fluid; a one-way valve, which allows flow from the peritoneum to the venous system but no reverse flow; and a venous catheter, which discharges the ascites fluid into the central venous system. The fluid transfer happens automatically when the patient lies down, because of the pressure differential between the peritoneal cavity and the central venous system. The spontaneous rate of transfer can be supplemented by manual pumping of the chamber. Pumping may also help limit buildup of fibrinous debris in the chamber. All components of the shunt are made of silicone rubber.

The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other pleural effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the relief of symptoms associated with pleural effusion, and 2) to provide a means for the instillation of physician-prescribed medications into the pleural space, and 3) to provide a means for pleurodesis (resolution of the pleural effusion).

The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.