Description

The Hem-o-lok® Polymer Locking Ligation System offers a reliable solution for surgical ligation needs across various procedures, including open, laparoscopic, and robotic surgeries. These non-absorbable clips are crafted from a biocompatible acetyl polymer, ensuring they are inert, non-conductive, and radiolucent, thus not interfering with diagnostic imaging techniques like CT, MRI, or X-rays.

Key Features

• Secure Closure: The proprietary distal locking mechanism provides both tactile and auditory feedback, ensuring a secure closure with minimal risk of slippage or migration.
• Cold Ligation: Eliminates the risk of thermal injury to surrounding tissues, offering a safer alternative to thermal ligation methods.
• Design: Integrated ridges and teeth provide a 360° grip, preventing slippage, while the flexible hinge allows for easy passage through smaller ports.
• Color Coding: Clips are color-coded for easy size identification, enhancing usability in complex surgical environments.

Sizes and Compatibility

Available in sizes ranging from Medium to Extra-Large, these clips are suitable for vessels and tissue structures of various dimensions. They are compatible with both manual and automatic appliers, which are available in different lengths and jaw types. The appliers are reusable, requiring specific cleaning and sterilization procedures, and are color-coded to match the clip cartridges.

Indications and Contraindications

Hem-o-lok Clips are indicated for use in a wide array of surgical procedures, such as:

• Laparoscopic appendectomy
• Cholecystectomy
• Bowel resection
• Urological and gynecological surgeries

They are not intended for use as a fallopian contraceptive tubal occlusion device and are contraindicated for ligating the renal artery during laparoscopic donor nephrectomies.

Clinical Safety

Clinical studies underscore the effectiveness and safety of Hem-o-lok Clips, with rare complications when applied correctly. Proper training and adherence to application guidelines are crucial to avoid issues such as clip migration or erosion. For large vessels, the use of multiple clips is recommended to ensure secure ligation.

Maintenance

The maintenance of compatible instruments involves regular cleaning, inspection, and lubrication with a non-silicone, water-based lubricant. Detailed instructions accompany the product to guide users in proper handling and care.

Regulatory Compliance

These clips are MR Safe and comply with ISO10993-1 standards for patient-contacting materials. They are classified as Class II under 21 CFR 878.4300, ensuring adherence to regulatory requirements for implantable clips.

The Hem-o-lok® system, with its comprehensive features and clear guidelines, provides a dependable ligation solution tailored to meet the diverse needs of surgical professionals.