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The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

The Enpath Deflectable Catheter is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve. The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber. The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve. The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes. The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.

The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks. The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force. Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.