Integer Holdings Corporation
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IntegerGuiding Catheters & Sheaths

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We provide a full range of guiding catheters and sheaths for peripheral vascular applications that supports every phase of the product life cycle. Design and development of guiding catheters and sheaths for peripheral vascular applications. Transfer of products and processes from one site to another to support product-line transfer, line duplication, low-cost manufacturing, and prototype-to-production migration. Manufacture of completed guiding catheters and sheaths as well as custom medical device components, including multi-layer, multi-durometer shafts with braid, PTFE liner, proximal visual markers and embedded marker bands.  Design for manufacturability (DFM) to assure that final products can be repeatedly manufactured while meeting quality, reliability, and performance requirements.

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Clinical and regulatory expertise; understanding of emerging clinical trends through our physician advisory board; preclinical product evaluation; validated mechanical and electrical test methods; and medical device registration, reporting, and vigilance.

With comprehensive manufacturing capabilities, we develop guiding catheters and sheaths in a wide range of models and configurations. Our technical experts ensure the highest-quality materials are matched to the precise design specifications and requirements of every component and device we manufacture.

We maintain ISO 13485 certification across our facilities, as well as quality and process management systems that meet the highest standards set by the United States Food and Drug Administration, the European Community, and other international regulatory authorities. Our technical experts ensure design for manufacturability to decrease development time, minimize costs, and achieve speed to market.

Molding

Master Unit Die (MUD), single- or dual-cavity and insert molding

Extrusion

Low- & high-melt polymers, single-lumen, multi-lumen, bump tubing, co-extrusion, wire enforced, braided and liners

Wire Drawing & Dielectric Coating

Substrates: Clad wire, MP35N, stainless steel, platinum and polymer coatings PTFE, ETFE, polyimide, polyethylene and nylon

Reinforcement Shafts

Computer modeling (Virtual Tube Modeling™) to maximize performance, braided, coiled, lamination, multi-durometer polymers, radiopaque-loaded polymers, reflowed shafts, pressure extrusion, thin-walled tight tolerance and lubricous liners

Support Members & Machined Components

Coils, marker bands, laser/machined-metal spines and ground cores, CNC machining, laser cutting, laser hole drilling, EDM and precious metals (platinum, gold & other alloys)

Assembly

Hub molding, reflow, tipping and handle attachment