BackNAVISURG AchillesBridge™ Set is designed to support minimally invasive Achilles tendon suturing, enabling effective repair of acute or subacute tendon ruptures. The set includes an anatomically guided positioning instrument and specialized passing needles, ensuring secure and stable sutures while minimizing skin and soft-tissue trauma. Its anatomical design reduces the risk of injury to the tibial nerve, shortens surgical time, and enhances cosmetic outcomes with smaller incisions and minimal scarring.
Product Information
- Product Name: NAVISURG AchillesBridge™ Set
- Device Owner / Brand Owner: NOVAMED GLOBAL JOINT STOCK COMPANY
- Country of Origin: Vietnam
- Indication: Designed for minimally invasive/percutaneous repair of acute or subacute Achilles tendon ruptures, reducing soft tissue complications compared to open surgery.
Product Description
Guide Instrument:
- Made of medical-grade metal, reusable.
- Anatomically designed for the Achilles tendon region to securely capture both tendon ends through the skin.
Suture Needle:
- Specialized needle for percutaneous passage of sutures with minimal tissue disruption.
- Supports horizontal, locking, or combined suture techniques.
- Ensures stability of tendon repair.
Intention for Uses
The kit is intended for:
- Acute Achilles tendon rupture (< 4 weeks).
- Partial ruptures requiring percutaneous reinforcement.
- Cases with weak soft tissue where open surgery poses a higher complication risk.
- Middle-aged or elderly patients.
- Patients with damaged skin or soft tissue.
- Patients with systemic conditions such as diabetes or rheumatoid arthritis.
Purpose:
- Facilitate minimally invasive Achilles tendon repair, reduce complications, and accelerate recovery.
Contraindications
Do not use in cases of:
- Infection at the surgical site.
- Chronic Achilles tendon rupture with large gaps unsuitable for percutaneous repair.
- Hypersensitivity to suture material or kit components.
- Calcaneal fractures or complex ankle injuries require open surgery.
Intended Users
- Orthopedic surgeons specialize in trauma
- Usage Environment: Sterile, standard-compliant operating room
Product Advantages
- Anatomically accurate guide design for the Achilles tendon.
- Minimizes risk of tibial nerve injury.
- Creates strong and uniform suture paths, enhancing mechanical stability.
- Optimizes surgical time.
- High aesthetic outcome: small incision, minimal scarring.
- Reduces risk of infection and wound dehiscence compared to open techniques.
Usage Procedure
Summary of procedure:
- Locate and mark the tendon; determine rupture site via ultrasound or clinical exam.
- Place the guide instrument along the Achilles tendon percutaneously.
- Pass sutures and secure tendon ends using the guide and suture needle at designated points.
- Pull and tension sutures to approximate tendon ends.
- Verify tendon tension, continuity, and stability; finalize knot tying.
- Close skin with minimal incision.
Storage & Sterilization
Guide Instrument:
- Sterilizable by steam autoclave.
- Store in a dry place, avoid corrosion.
Suture Needle:
- Sterile, single-use packaging.
- Do not use if the packaging is damaged, wet, or compromised.
Warnings
- To be used only by trained healthcare professionals.
- Do not reuse the suture needle.
- Improper technique may lead to serious complications.
- Strict adherence to aseptic technique is required.