Vertex(TM) Catheter

The Vertex Catheter is a single-use catheter introducer inserted into blood vessels to provide a conduit for advancing endovascular devices while minimizing blood loss. It consists of a multilayer composite shaft with hydrophilic inner and hydrophobic outer coatings, an attached hemostatic valve with silicone seal, and an included locking obturator (dilator). The device is radiopaque and available in two sizes with three length options.

Both the Vertex Catheter and predicate GORE DrySeal Flex Introducer are composite tubes with flat stainless steel wire reinforcement, hemostatic valves (Vertex uses compression-controlled silicone; GORE uses pressurized dual-chamber design), and tapered locking dilators compatible with 0.035" guidewires. Key differences: Vertex offers 2 sizes vs. GORE's 17 sizes; Vertex lengths are 77–107 cm vs. GORE's 33–65 cm; Vertex uses a fixation line for on-demand positioning control.

ISO 10993 biocompatibility standards including ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 10993-11 (systemic toxicity and pyrogenicity), and ISO 10993-4 (hemocompatibility: hemolysis, thromboplastin time, complement activation, platelet and leukocyte counts). Non-clinical testing includes dimensional verification, compatibility, radiodetectability, kink resistance, tensile strength, burst pressure, lubricity, and particulation.

The Vertex Catheter shares identical indications for use (prescription single-use device for vascular access in diagnostic/therapeutic procedures) and the same fundamental operational principle—manual deployment to provide a stable conduit for accessory device advancement with minimal tissue disturbance. Both devices employ similar materials (composite multilayer construction with stainless steel reinforcement and hemostatic sealing), undergo identical sterilization (ethylene oxide), and satisfy equivalent non-clinical and biocompatibility testing. Although Vertex uses a fixed/relaxed compression mechanism versus GORE's pressurized valve, both achieve the same hemostatic function; the architectural differences do not alter the essential safety or effectiveness profile for the intended use.