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This device is intended for use with Flex-Neck catheters and Ash Advantage catheters in the event one of two situations described below should occur: 1. Extender Application In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be. 2. Repair Application If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing. In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.

This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.

The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.

Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter.

The Ash Advantage™ Peritoneal Catheter is intended to provide access for passage of dialysate during chronic peritoneal dialysis (PD) such as Continuous Ambulatory Peritoneal Dialysis (CAPD). If the patient is a suitable candidate for (PD) therapy, the Ash Advantage™ Peritoneal Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Ash Advantage™ Peritoneal Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the Tenckhoff catheter contains multiple 1.0 mm holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip; however, outflow continues through the multiple side holes. The Ash Advantage™ Peritoneal Catheter has been developed with a thin trans-abdominal tube connecting in an inverted "T" shape to a cylindrical portion which changes to longitudinal flutes (grooves) for ports, which rest against the parietal peritoneum. The Ash Advantage™ Peritoneal Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system, which is used to insert the standard Tenckhoff dialysis catheters. The fixed position of the intraperitoneal portion of this catheter is designed to prevent outward migration of the deep and superficial cuffs, avoiding pericatheter hernias, pericatheter leaks, and erosion and infection of the subcutaneous cuff. Though this Ash Advantage™ Peritoneal Catheter is a novel design for peritoneal catheters used in dialysis, it actually represents a simple combination of two catheters which are currently utilized in medical practice for peritoneal access. The portion of the catheter outside the peritoneum is exactly like the Tenckhoff catheter, with deep and superficial cuffs. The fluted portion within the abdomen is exactly like a drain used to remove fluid from the peritoneum after surgery, the Blake™ Drain by Johnson & Johnson. The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to existing catheters and drains. The extrusions are bonded to form the inverted "T" which is then reinforced with molded silicone.

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.