BOSTON SCIENTIFIC M001262040 Needle Electrodes

Condition: New
Part #: M001262040

$3,000.00

BOSTON SCIENTIFIC M001262040 Needle Electrodes

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M001262280,M001262040,M001262230,M001262250…….

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Description

The Boston Scientific M001262040 Needle Electrode is a cornerstone of the LeVeen™ product family, specifically engineered for high-precision radiofrequency ablation (RFA). This medical-grade instrument is designed to address liver tumors and various soft tissue lesions by delivering targeted thermal energy through a sophisticated, multi-tine array. By facilitating minimally invasive access and providing real-time feedback, the M001262040 allows interventional oncologists to achieve predictable, spherical necrosis zones, effectively destroying malignant tissue while sparing surrounding healthy structures.


Core Technology: The LeVeen™ Umbrella Array

The M001262040 utilizes an expandable umbrella-shaped array consisting of multiple curved tines. Unlike single-needle electrodes that may produce inconsistent lesion shapes, the LeVeen™ system deploys its tines into a 3.0 cm diameter configuration. This multi-point delivery system ensures that radiofrequency energy is distributed evenly throughout the target volume, creating a consistent “kill zone” that matches the tumor’s spherical geometry.

Mechanism of Action

The device operates in tandem with the RF 3000® Generator to perform tissue ablation via the following steps:

  • Percutaneous Access: The 13-gauge cannula is inserted into the tumor under imaging guidance (Ultrasound or CT).

  • Deployment: Once positioned, the internal tines are deployed into the tissue, forming the 3.0 cm diameter array.

  • Thermal Ablation: The RF 3000® Generator sends high-frequency current through the tines. This causes ionic agitation in the tissue, generating frictional heat that leads to coagulative necrosis.

  • Impedance Monitoring: The system monitors tissue impedance in real-time. As cells are destroyed, impedance rises; the generator detects this “roll-off,” providing the clinician with objective confirmation that the ablation is complete.

Applications and Clinical Uses

The M001262040 is primarily utilized in interventional oncology for:

  • Hepatocellular Carcinoma (HCC): Ablation of primary liver tumors.

  • Metastatic Liver Disease: Treating lesions that have spread from other primary sites (e.g., colorectal cancer).

  • Soft Tissue Lesions: Ablation of benign or malignant tumors in various non-vascular soft tissues.

  • Palliative Care: Reducing tumor burden to alleviate symptoms in non-resectable patients.

Key Advantages

  • Predictable Spherical Lesions: The 1 cm tine spacing ensures a uniform thermal field, resulting in a repeatable and predictable ablation volume.

  • Impedance Feedback: Eliminates guesswork by providing automated confirmation of successful tissue destruction.

  • Minimally Invasive: The 13-gauge shaft minimizes entry site trauma, reducing recovery time compared to open surgical resections.

  • Stable Deployment: The array is designed for mechanical stability within the tissue, preventing the electrode from shifting during the heating cycle.

Treatment Process

  1. Guidance: The clinician uses Ultrasound or CT to visualize the tumor.

  2. Insertion: The 12 cm cannula is advanced through the skin into the center of the lesion.

  3. Expansion: The handle mechanism is used to deploy the tines.

  4. Ablation Cycle: The generator is activated, and power is titrated based on the specific protocol for a 3.0 cm array.

  5. Roll-off: The procedure continues until a significant rise in impedance is noted.

  6. Retraction: The tines are retracted back into the cannula, and the device is withdrawn.


Technical Specifications

Feature Specification
Model Number M001262040
Array Diameter 3.0 cm
Cannula Length 12 cm
Shaft Gauge 13-Gauge
Generator Compatibility Medtronic / Boston Scientific RF 3000®
Usage Single-Use, Sterile

Frequently Asked Questions

What is the primary function of the Boston Scientific M001262040? The M001262040 is a needle electrode used for radiofrequency ablation (RFA). It is designed to be inserted into tumors (primarily in the liver) to deliver thermal energy that destroys malignant cells through heat, providing a minimally invasive alternative to traditional surgical resection.

How does the umbrella array design benefit the patient? The umbrella-shaped array allows for the creation of a precise, spherical lesion. This ensures that the entire volume of a 3.0 cm tumor is treated evenly, reducing the risk of leaving viable cancer cells behind (local recurrence) while minimizing damage to the surrounding healthy liver tissue.

Is the M001262040 compatible with any RF generator? This electrode is specifically designed and validated for use with the RF 3000® Generator. This compatibility is crucial because the generator is calibrated to recognize the impedance feedback from the LeVeen™ tines, ensuring the “roll-off” confirmation is accurate and the procedure is safe.

Can the M001262040 be reused after sterilization? No, this is a single-use, sterile device. Reusing RFA electrodes is prohibited due to the risk of cross-contamination and the potential for mechanical failure of the tines. Single-use ensures the sharp tip and deployment mechanism function perfectly for every procedure.

What is the significance of the 13-gauge shaft? The 13-gauge shaft is relatively thin, allowing for a minimally invasive percutaneous approach. This results in a smaller puncture site, less post-operative pain for the patient, and a significantly lower risk of complications compared to larger-bore instruments or open surgery.

How does the surgeon know when the tumor is fully ablated? The system uses real-time impedance monitoring. When the tissue is fully desiccated (destroyed), its resistance to electrical current (impedance) increases sharply. The RF 3000® generator detects this change, known as “roll-off,” signaling the surgeon that the treatment is complete.

Listing Terms & Conditions

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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.