Product Overview

Fisiograft Sponge is a cutting-edge synthetic bone biomaterial produced through the lyophilization of a polylactic-polyglycolic (PLA-PGA) copolymer combined with 130 mg of Dextran. This unique composition results in a medium-consistency material, perfectly suited for various regenerative surgical procedures.

When hydrated with physiological saline or blood, the material softens significantly, allowing for easy and precise placement into the recipient site without the need for compaction, simplifying the surgical procedure.

Medical Device Classification

FISIOGRAFT is classified as a medical device specifically engineered for use in regenerative surgery.

• Contact Surface: Bone tissue
• Contact Duration: Between 60 and 180 days, allowing ample time for natural bone regeneration.
• Intended Use: Professional clinical application only.

Intended Users

FISIOGRAFT is designed for specialized professionals in the field of regenerative medicine:

• Dentists
• Implantologists
• Periodontologists
• Maxillofacial Surgeons

Key Features

The Fisiograft biomaterial embodies several critical features for optimal performance and safety:

• Single-Use Product: Ensures sterility and eliminates the risk of cross-contamination.
• Sterilization: Sterilized effectively with Gamma rays (25 kGy) to meet stringent medical standards.
• Biologically Resorbable Compounds: Composed of materials designed to be naturally absorbed by the body over time, supporting biological integration. These include:
  • Polylactic Acid (PLA)
  • Polyglycolic Acid (PGA)

PLA-PGA Copolymer Functionality

The PLA-PGA copolymer in Fisiograft is engineered for specific functions:

• Low Density: Provides an ideal structural framework for tissue integration.
• Resorbable Space Maintainer: Acts as a crucial temporary barrier between the bone defect plane and the overlying connective tissue, preserving the necessary space for new bone formation.
• Blood Permeability: Designed to become permeable to blood, facilitating the infiltration of osteocytes and other regenerative cells. This mechanism enables the gradual replacement of the biomaterial by natural bone tissue within a relatively short period, promoting effective healing.

Biocompatibility and Safety

The polymer utilized in Fisiograft adheres to the highest standards of biocompatibility:

• It is highly biocompatible with human tissues.
• It is non-allergenic, minimizing the risk of adverse reactions.
• It does not induce any inflammatory response, ensuring a smooth healing process.

Resorption Mechanism

Fisiograft is designed for a natural resorption process:

The material is progressively and completely permeated and replaced by trabecular bone, seamlessly integrating with the body's natural bone structure and supporting long-term regeneration.

Advantages of Versatile Forms

Fisiograft is available in various forms (including the sponge format), which, whether used alone or in combination, provide significant advantages:

• Ensures easier and more adaptable placement within the surgical site.
• Facilitates enhanced integration with surrounding tissues, promoting superior regenerative outcomes.