BOSTON SCIENTIFIC M001262230 Needle Electrodes

Condition: New
Part #: M001262230

$3,500.00

BOSTON SCIENTIFIC M001262230 Needle Electrodes

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M001262280,M001262040,M001262230,M001262250…….

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Description

The Boston Scientific M001262230 is a specialized needle electrode within the LeVeen™ CoAccess™ family, engineered specifically for the radiofrequency ablation (RFA) of soft tissue tumors. This 14-gauge instrument is a gold standard for clinicians performing percutaneous, laparoscopic, or open surgical procedures to treat lesions in organs such as the liver. By utilizing a unique expandable array, the M001262230 allows for the creation of precise, large-volume spherical thermal lesions while minimizing damage to surrounding healthy tissue.


Core Technology: The LeVeen™ Design

The hallmark of the M001262230 is its umbrella-shaped electrode array. When retracted, the device functions as a standard 14-gauge needle for easy insertion. Once positioned at the target site, the clinician deploys the array to a 3.5 cm diameter.

  • 14-Gauge Cannula: Provides the structural rigidity needed for accurate placement through dense tissue.

  • CoAccess™ System: Features a unique design that allows for needle or wire exchange without losing the original access tract, reducing trauma and procedural complexity.

  • Impedance-Based Feedback: Designed to work in tandem with the RF 3000™ Generator, the system monitors tissue impedance in real-time to ensure complete ablation.


Mechanism of Action

The ablation process follows a specific thermal protocol to ensure oncological safety:

  1. Deployment: The 15 cm cannula is inserted under imaging guidance (Ultrasound or CT).

  2. Expansion: The tines are deployed into the tumor, forming a spherical “umbrella” that encompasses the lesion.

  3. RF Delivery: The RF 3000™ Generator delivers up to 200W of power. As the high-frequency current passes through the tines, it causes ionic agitation in the tissue, generating frictional heat.

  4. Cellular Death: Once the tissue temperature reaches approximately 50°C to 100°C, protein denaturation and coagulative necrosis occur, effectively destroying the tumor cells.


Clinical Applications

The LeVeen™ M001262230 is primarily indicated for the ablation of non-resectable soft tissue tumors.

  • Liver Lesions: Frequently used for Hepatocellular Carcinoma (HCC) and metastatic liver disease.

  • Soft Tissue Tumors: Applicable in various visceral organs where a spherical ablation zone is required.

  • Multi-Modality Access: Optimized for percutaneous (through the skin), laparoscopic, or open surgical approaches.


Key Advantages for Surgeons

  • Predictable Lesion Geometry: The 1 cm tine spacing ensures uniform heat distribution, resulting in consistent, spherical ablation zones.

  • Efficient Penetration: Tines are polished and sharp, allowing for smooth deployment even in cirrhotic or fibrotic tissue.

  • Time Efficiency: High power output (up to 200W) significantly reduces the time required for large-volume ablations compared to single-needle systems.

  • Tract Protection: The CoAccess™ design minimizes the risk of track seeding and reduces the need for multiple punctures.


Technical Specifications

Feature Specification
Model Number M001262230
Array Diameter 3.5 cm
Cannula Length 15 cm
Needle Gauge 14 G
Compatibility Boston Scientific RF 3000™ Generator
Max Power Output 200W
Deployment Shape Umbrella / Spherical Array

Frequently Asked Questions

What are the primary indications for using the LeVeen M001262230?

The M001262230 is primarily used for the radiofrequency ablation (RFA) of soft tissue tumors, most commonly liver lesions like hepatocellular carcinoma or metastatic tumors. It is designed for patients who may not be candidates for traditional surgical resection, providing a minimally invasive alternative to destroy malignant tissue through thermal energy.

How does the CoAccess™ design benefit the procedural workflow?

The CoAccess™ design is a critical feature that allows clinicians to perform needle or instrument exchanges through the same access site without disrupting the established tract. This significantly reduces procedural time, minimizes patient trauma, and helps maintain a stable positioning during complex RFA procedures that might require multiple steps.

Is the M001262230 compatible with any RF generator?

For optimal safety and performance, the M001262230 is specifically designed to pair with the Boston Scientific RF 3000™ Generator. This combination allows for precise power delivery up to 200W and enables the continuous impedance monitoring necessary to determine the “roll-off” point, signaling the completion of the ablation.

What is the difference between the 3.0 cm and 3.5 cm LeVeen models?

The primary difference is the diameter of the deployed electrode array. The M001262230 (3.5 cm) creates a larger spherical lesion than the M001262220 (3.0 cm). Choosing between models depends on the size of the target tumor and the required safety margin to ensure all malignant cells are treated.

How does the system ensure that the entire tumor is ablated?

The LeVeen system uses 1 cm tine spacing to create predictable and complete thermal lesions. During the procedure, the RF 3000™ Generator monitors tissue impedance. As the tissue becomes desiccated and ablated, impedance rises significantly (the “roll-off”), providing a reliable clinical indicator that the target area has reached lethal temperatures.

Can this needle electrode be used in laparoscopic surgery?

Yes, the 15 cm cannula length and 14-gauge diameter make the M001262230 suitable for percutaneous, laparoscopic, and open surgical procedures. Its versatility allows surgical teams to select the best approach based on the tumor’s location, the patient’s overall health, and the available imaging guidance.

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