NAVISURG GraftTension™ Pro

Product Information

• Product Name: NAVISURG GraftTension™ Pro
• Device Owner / Brand Owner: NOVAMED GLOBAL JOINT STOCK COMPANY
• Country of Origin: Vietnam
• Application: Preparation and pre-tensioning of tendon grafts used in cruciate ligament reconstruction.
• Purpose: To provide stable fixation and precise graft tensioning during graft preparation, contributing to consistent surgical performance.

Product Description 

The GraftTension Pro™ is designed as a comprehensive support system for:

• Securing tendon grafts.
• Measuring projected graft length under tension.
• Applying stable, controlled traction.
• Compatibility with various graft types, including hamstring, patellar tendon, or long peroneal tendon.

Structure includes:

• Table frame: High durability, easy to sterilize.
• Tendon fixation clamps: Securely hold the graft without causing tissue damage.
• Length measuring scale: Enables accurate measurement of graft length after tensioning.
• Tension adjustment unit: Allows controlled, uniform tension application.
• Attachment area for suspension buttons: Compatible with various fixation buttons.

Intention for Uses 

The device is intended for:

• ACL reconstruction surgery using single or double tendon grafts.
• Graft preparation, including button fixation, length measurement, and pre-tensioning.
• Techniques such as All-inside, EndoSTAR, UltraSTAR, or four-strand Hamstring graft procedures.

Contraindications 

Do not use the device in cases of:

• Severely damaged grafts that cannot be secured on the table.
• Grafts unsuitable for ACL reconstruction.
• Users without orthopedic surgical training or proper instruction.

Intended Users 

• Orthopedic trauma surgeons.
• Operating room technicians.
• Trained medical personnel responsible for surgical graft preparation.

Product Advantages 

Addresses limitations of manual tensioning:

• Manual graft tensioning often leads to uneven tension in the tissue, resulting in unpredictable graft length.
• The Graft Preparation & Tensioning Table provides uniform traction, ensuring even stress distribution along the graft and surrounding tissue, optimizing graft quality.

Key Advantages:

• High precision: Standardized length measurement allows accurate prediction of graft length in the tunnel.
• Controlled tension: Reduces graft laxity after fixation, improving postoperative knee stability.
• Secure graft holding: Prevents tissue damage and deformation during manipulation.
• Versatile compatibility: Supports multiple graft types, button sizes, and modern surgical techniques.
• Workflow optimization: Reduces graft preparation time and minimizes procedural errors.

Usage Procedure 

• Secure the graft on the table using specialized clamps.
• Attach the suspension button to the graft end.
• Adjust the length scale to predict the post-tensioned graft length.
• Apply pre-tension using the tension adjustment unit.
• Wrap and standardize the graft according to surgical technique.
• Verify the final length before proceeding to graft implantation.

Storage & Sterilization 

• Made from medical-grade steel compatible with steam sterilization.
• Store in a dry environment, avoiding strong impacts.
• Inspect clamps and measurement scales before each use.
• Do not use if bent, deformed, or damaged.

Warnings

• For use only by surgeons trained in cruciate ligament reconstruction procedures.
• Strictly follow aseptic principles.
• Ensure tension does not exceed recommended limits to avoid tendon damage.
• Do not use for purposes other than indicated.
• Check clamp stability before operation.