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Sheath Retouch

EP Steerable Introducer Sheaths & Transseptal Sheaths

We provide a full range of solutions to support every phase of the product life cycle for an EP steerable introducer sheath and transseptal sheath used in TMVR and LAA applications.

  • Design and development of steerable introducer sheaths and transseptal sheaths.
  • 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 standard and custom structural heart device components, including polyimide-coated wire, high-spring constant coils, braided shafts, polyimide tubing, braided multi-lumen extrusions, PT electrodes and marker bands, welded electrode assemblies, coated stainless wire-welded pull cables, thermocouples, micro-machined components, micro-molding, and machined and molded handles.
  • Design for manufacturability (DFM) to assure that final products can be repeatedly manufactured while meeting quality, reliability, and performance requirements.
  • Clinical and regulatory expertise through our physician advisory board; preclinical product evaluation; validated test methods; and medical device registration, reporting, and vigilance.

With comprehensive manufacturing capabilities, we develop 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.​

SH Handles

Handles (Single & Bi-directional)

Custom design, off-the-shelf prototypes, ABS molding, Polycarbonate molding, Santoprene™ molding, metal components and MIM components

Molding Steerable

Molding

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

Polymer Extrusion

Extrusion

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

Coated Wire

Wire Drawing & Dielectric Coating

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

Reinforcement Shaft

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

Marker Band Product

Support Members

Coils, marker bands, laser/machined-metal spines

Deflectable Sheath

Pull Cables

Resistance laser welding, soldering and sub-assemblies

Machined Catheter

Machined Components

CNC machining, laser cutting, laser hole drilling, EDM and precious metals (platinum, gold, & other alloys)

Assembled Steerable Sheath

Assembly

Hub molding, reflow, tipping and handle attachment

We maintain strong R&D investment to develop new technologies that complement customer initiatives to incorporate electrical and optical capabilities into catheters and sheaths. Throughout our partnership, we provide the mechanical design, process design, device testing, material testing, inspection, traceability, and documentation required to meet complex and sophisticated requirements. We support customers with the following catheter enabling platforms:

  • Mechanical competencies in delivery platforms, materials joining and precision coating to develop miniaturized sensor, electrical, and optical components.
  • Advanced electrical and optical design capabilities in fine wire joining, proximal ring connectors, sensor connector attachment, optical fiber connectors, optical fiber polishing, and wire bonding.
  • Clinical and design assurance to perform benchmark testing, technology research, and clinical evaluation.
OEM-Unison

Steerable Sheath with Dilator

  • Proprietary single pull-wire steerable platform
  • Articulating sheath tip
  • Handle with integrated locking mechanism
  • 67 cm working length
  • Regulatory-approved steerable sheath in 8F and 9F sizes
    • 8 Fr sizes (ID: 2.7mm, OD: 3.8 mm)
      • 3.94 cm active tip reach at 90 degree deflection
      • 3.15 cm curve at 180 degree deflection
    • 9 Fr sizes (ID: 3.1 mm, OD: 4.2 mm)
      • 4.5 cm active tip reach at 90 degree deflection
      • 4.2 cm curve diameter at 180 degree deflection