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The Laguna Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Laguna Thrombectomy System is intended for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Malibu Aspiration Catheter™ System is intended for use in the peripheral vasculature.

The Laguna Clot Retriever™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Laguna Clot Retriever™ System is intended be used in conjunction with the Malibu Aspiration Catheter™ System. The combined use of the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System is referred to as the Laguna Thrombectomy System. The Laguna Clot Retriever™ is used to engage and retrieve emboli and thrombi into the Malibu Aspiration Catheter™. The Laguna Clot Retriever™ is designed with a flexible pusher attached to a distal self-expanding, laser cut, closed cell design Nitinol structure. The self-expanding portion is delivered inside a delivery sheath. The flexible pusher is designed with stainless steel reinforcement and a polymer. The retriever head is designed with and without radiopaque body markers. The retriever head designed with radiopaque body markers is intended to visualize the expansion and collapse of the Laguna Clot Retriever™. The Malibu Aspiration Catheter™ System is a single use, sterile, non-pyrogenic medical device designed for use in the peripheral vasculature. The Malibu Aspiration Catheter™ System is intended be used independently and in conjunction with the Laguna Clot Retriever™ System. The Malibu Aspiration Catheter™ is intended for retrieving thrombi or emboli and/or infusing fluids into the peripheral vasculature. The Malibu Aspiration Catheter™ is designed with a single lumen and comprised of tubes for aspiration and infusion connected proximally to its hub. Two-way flow control valves are located at the end of aspiration and infusion tubes, respectively. The aspiration tube can be connected to a locking vacuum syringe via its two-way valve. Similarly, the infusion tube can be connected to a syringe to infuse fluids through the catheter. The Malibu Aspiration Catheter™ is designed with a radiopaque marker band at the distal tip for fluoroscopic visualization. In addition, the Malibu Aspiration Catheter™ is also available with a second marker band located proximally to the distal marker band. The Malibu Aspiration Catheter™ is supplied with a dilator and a 60cc locking syringe. The Malibu Aspiration Catheter™ incorporates a metallic reinforcement made of stainless steel, an inner liner made of polytetrafluoroethylene, and polymeric jacket material having gradient softness. The distal segment of the Malibu Aspiration Catheter™ is coated with a hydrophilic coating to optimize lubricity and reduce friction.