Steerable Sheaths

The Agilis NxT steerable introducer consists of a steerable sheath, dilator, and guidewire.The steerable introducer is a bi-directional transseptal guiding sheath utilized by many EP interventionalists for ablation and mapping procedures. It is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum. The guiding sheath provides enhanced control, navigation, and rotation for optimal application of ablation therapies to achieve desired clinical results. The braded low profile Agilis NxT sheath provides enhanced stability and durability in combination with an integrated stabilized steering mechanism.

Cleaning

Innovative Health’s validated cleaning process has been specifically designed and tested to provide consistent and repeatable results with high confidence and reliability. Upon receipt, the devices are disassembled to allow for access to both lumens and valves. The first step in the reprocessing process is the reduction of organic and inorganic contamination (e.g. hemoglobin, protein) and chemical residue (e.g. Total Organic Carbon (TOC)). This is achieved utilizing manual debris removal techniques, enzymatic cleaners, and Reverse Osmosis (RO) water.

The process has been validated in accordance with AAMI TIR-30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and FDA recommendations. This standard is considered to be the gold standard in cleaning medical devices.

Hemostasis Valves

The hemostasis valves are pressure test challenged on a proprietary leak test system
prior to and following assembly. The same system is also used to test dilators and
introducers for leaks and occlusions.

Reprocessed introducers are tested to withstand blood pressure ranges greater than those seen in patients presenting with Stage 4 hypertension. The test parameters exceed performance standards to ensure patient safety.

Following extensive inspection and testing, device sets are reassembled. New hemostasis caps are bonded, locking the valves in place. The addition of a new stopcock completes the assembly. The completed device is subjected to a second phase of pressure testing to ensure the device performs as intended and meets Innovative Health’s strict quality standards. Following the same phases of cleaning, testing and inspection, Agilis dilators are pressure tested and then coated with a medical grade biocompatible lubricant to enhance crossing profile and reduce insertion forces into the introducer nearly 10x. Dilators are paired with an introducer and packaged with a new J-tip guidewire.

The Environment

Our logo isn’t the only thing that is “green”. Our easy-to-open, branded packaging uses considerably less material than the original manufacturer, allowing for nearly twice as many devices to be stored in the same space. We have also replaced the vinyl-based tray with a more eco-friendly polymer, which performs just as well and is 100% recyclable.

Inspection

Inspection of the introducer sheath and dilator is performed throughout the process to ensure devices meet Innovative Health’s internal requirements. The devices undergo internal and external inspection using lighted magnification, tactile assessment, leak testing, and functional evaluation (i.e. curve deflection, stopcock function, and luer lock connectivity) using specifically designed curve templates to align with the original manufacturer’s specifications.

A Validated Process

Exhaustive testing was conducted to verify and validate Innovative Health’s decontamination, cleaning, assembly, packaging and sterilization processes. During the design and development phase, the following functionality tests/assessments are performed: Visual Inspection, Dimensional Inspection, Packaging Assessment, Valve Leak Testing, Joint Leak Testing, Simulated Use, Catheter Joint Tensile Testing and Radiopacity. These devices and related processes are validated according to accepted FDA and industry standards such as ISO, AAMI, etc. and to meet applicable confidence intervals as required.

Reprocessing the Agilis Introducer involves the following steps:

*Some tests are performed during validation activities only.

Select a brochure below and click to download!

*Agilis is a trademark of or licensed to St. Jude Medical or one of its subsidiaries.


IFUs