INTUITIVE 490103 21g biopsy needle

Condition: New
Part #: 490103

$2,500.00

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Description

The Intuitive 490103 is a high-precision, sterile, single-use Flexision™ Biopsy Needle specifically engineered for use with the Ion Endoluminal System. As a cornerstone of robotic-assisted bronchoscopy, this 21-gauge needle is designed to navigate the highly tortuous pathways of the peripheral lungs to reach small, hard-to-access nodules.

By combining extreme flexibility with a rigid, laser-etched stainless steel stylet, the 490103 ensures that clinicians can obtain high-quality tissue samples with minimal trauma. Its integration with the Ion platform allows for a seamless “plan-to-procedure” workflow, enhancing diagnostic yield in early-stage lung cancer screenings.


Core Technology: Flexision™ Engineering

The success of peripheral lung biopsies depends on the device’s ability to maintain its integrity while bent at acute angles. The 490103 utilizes several proprietary technologies to achieve this:

  • Advanced Sheath Flexibility: The retractable sheath is designed to pass through the Ion’s 2.0 mm working channel without kinking, even in the most distal segments of the bronchial tree.

  • Laser-Etched Stylet: A stainless steel stylet provides the necessary column strength for tissue penetration while remaining flexible enough for multi-trajectory “cloud biopsy” techniques.

  • Radiopaque Visualization: The needle features a radiopaque tip, ensuring high visibility under fluoroscopic guidance and facilitating real-time adjustments during the biopsy.


Mechanism of Action

The Intuitive 490103 operates within a specialized robotic ecosystem to ensure precision:

  1. Deployment: The needle is advanced through the Ion catheter until it reaches the target nodule identified during pre-operative planning.

  2. Controlled Extension: Using an integrated stop, the clinician extends the needle precisely up to 3 cm into the lesion, preventing over-penetration and protecting adjacent vascular structures.

  3. Tissue Capture: The 21G diameter is optimized to capture sufficient cellular architecture for histological and cytological analysis.

  4. Retraction: The needle is safely retracted into the protective sheath before the catheter is moved to a new trajectory or withdrawn.


Clinical Applications and Compatibility

The 490103 is primarily used for Transbronchial Needle Aspiration (TBNA) of peripheral lung nodules. Its design supports a variety of modern diagnostic protocols:

  • Cloud Biopsy Techniques: The flexibility allows for sampling across multiple trajectories within a single nodule.

  • rEBUS Integration: Fully compatible with radial Endobronchial Ultrasound (rEBUS) for lesion verification prior to sampling.

  • Multimodal Sampling: Can be used alongside vision probes and systematic sampling protocols to maximize diagnostic accuracy.


Key Advantages: 21G vs. Alternative Gauges

Choosing the correct needle gauge is critical for balancing sample size with anatomical access. The 490103 (21G) sits at the “sweet spot” of performance:

Feature 21G (Model 490103) 19G Needle 23G Needle
Max Extension 3 cm 3 cm 3 cm
Flexibility High Moderate Highest
Sample Quality Excellent (Histology) Superior (Bulk tissue) Good (Fine cytology)
Primary Use Peripheral nodules Large central masses Ultra-fine tissue/Vascular areas

Technical Specifications

Component Specification
Part Number 490103
Gauge Size 21G
Max Needle Extension 3 cm
Working Channel Requirement 2.0 mm
Material Laser-etched Stainless Steel Stylet
Sterility Sterile, Single-use
Compatibility Ion Endoluminal System

Frequently Asked Questions

What are the primary benefits of the 21G size for lung biopsies? The 21-gauge needle (490103) provides an ideal balance between flexibility and sample volume. It is thin enough to navigate the tight bends of the peripheral airways while remaining substantial enough to collect intact tissue cores suitable for detailed histological analysis and molecular testing.

How does the 490103 support the “cloud biopsy” technique? Because the 490103 features a highly flexible Flexision™ sheath, it can be deployed at various angles and trajectories within a target nodule. This allows clinicians to sample multiple areas of a single lesion (the “cloud” approach), significantly increasing the likelihood of capturing malignant cells.

Is the Intuitive 490103 compatible with fluoroscopic imaging? Yes, the needle is equipped with a radiopaque tip. This feature is critical for peripheral biopsies, as it allows the surgical team to confirm the exact location of the needle tip relative to the nodule under fluoroscopy, ensuring the sample is taken from the intended target.

Does this needle work with non-robotic bronchoscopes? The 490103 is specifically designed and validated for the Ion Endoluminal System. While it requires a 2.0 mm working channel, its length and mechanical properties are optimized for the Ion’s robotic architecture to ensure precise extension and retraction during robotic-assisted procedures.

What safety features prevent accidental lung perforation? The needle includes an integrated stop that limits extension to a maximum of 3 cm. This allows for controlled, targeted biopsies. When used with the Ion platform’s real-time navigation, clinicians can precisely set the depth of the “throw” to match the dimensions of the nodule.

Can the 490103 be reused after sterilization? No, the Intuitive 490103 is a sterile, single-use device. Reusing biopsy needles poses significant risks of cross-contamination and mechanical failure. Single-use design ensures that the laser-etched stylet and flexible sheath maintain peak performance and sharpness for every procedure.

Listing Terms & Conditions

We ship worldwide, please inquire the shipping rate to your country before placing an order.

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All purchases over $1,000 must be paid by wire transfer. We cannot accept international credit card payments for orders over $1,000.

Due to worldwide shipping delays, it is possible that items listed could be on backorder. If the item is unavailable for an extended period, we sincerely apologize for the delay. In this case, we will refund you as soon as we are notified of the backorder and contact you with the confirmation of refund.