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The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the perioheral vascular system and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

The NexGen Peripheral Expandable Catheter is a sterile single use catheter intended to facilitate the placement or removal of vascular catheters and devices including the NexGen Mechanical Retrieval Device (MRD). The Device features a Pebax/HDPE catheter shaft attached Nitinol tip that expands as the device is deployed from the lumen of a guide catheter. The Nitinol braid passively expands to the contour shape of the vessel lumen and allows a separate medical device such as a catheter to be retracted into the Nitinol Braid. Both the Nitinol Braid and the other device are then retracted into the Guide Catheter. The retracted Expandable Catheter with the encapsulated device are then removed together via removal of the Guide Catheter. The Expandable Catheter comes in multiple expanded profiles of 5mm, 7mm, 9mm and 11mm, each having a working length of 43cm and 116cm. The Expandable Catheter is packaged in a Tear Away Sheath (B. Braun 510(k) K000313) that is used to facilitate loading the catheter into a Guide Catheter. Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

The NexGen Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

The MRD is a member of a family of sterile, single use, catheter-based devices that are intended to mechanically remove blood clots and other obstructions from blood vessels in the human body. The MRD is designed to be used for peripheral vascular applications. The Device design is intended to allow easier access into anatomically difficult endovascular locations because it is pushed out of a small profile guide catheter. Other devices such as those delivering laser, ultrasound, or photo-acoustical energy may be too stiff to access tortuous blood vessels, and too large. The MRD consists of a stainless steel coil that is inserted into a standard 4F guide catheter. The guide catheter is inserted into the vessel and past the occlusion using a standard guide catheter. Coils released from the MRD are then deployed distal to the occlusion. As the guide catheter is withdrawn, additional MRD coils are released proximal to the occlusion, thereby enmeshing the embolic material for removal.

Intended Use: The NexGen Peripheral Guide Catheter is intended for use in the peripheral vasculature for the intravascular introduction of interventional/diagnostic devices and the injection of physician specified fluids. This device is not intended for use in the coronary or cerebral vasculature.

The Peripheral Guide Catheter is a family of single use, catheters that are intended to facilitate introduction of interventional/diagnostic devices. The NexGen Peripheral Guide Catheter features a proximal hub for attaching to ancillary devices such as Rotating Hemostasis Valves and Syringes and a distal, atraumatic tip that is radiopaque. The catheter has a single lumen that can be used to facilitate introduction of interventional /diagnostic devices and injection of physician specified fluids. The Guide Catheter comes in two profiles, 4F and 8F and multiple lengths. The 4F profile has a 65cm and 150cm working length and the 8F profile has a 20cm and 90cm working length. Proximally located on the catheter shaft is a female luer connection for the attachment to a Hemostasis Valve Y Connector, which provides a means of introducing contrast media or other fluids. The Hemostasis Valve Y Connector is separate or a prepackaged component.

The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

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