DemeDAC™ Polyester Suture
DemeDAC ™ Polyester Braided Without Covering (PT)
DemeTECH Polyester Nonabsorbable Suture is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, long-chain linear polyester having recurrent aromatic rings as an integral component.
The sutures with attached needles meet FDA requirements for exempt color additives for polyester sutures. The product is available in several suture lengths and attached needle types. DemeTECH Polyester Nonabsorbable Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Sutures.
Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. Product is intended for long term use over 30 days.
Actions in Tissue.
The DemeTECH Polyester Nonabsorbable Suture elicits a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. DemeTECH Polyester Nonabsorbable Suture is not absorbed, nor is any significant change in tensile strength retention known to occur in vivo. High quality materials combined with precise braiding mechanisms nearly eliminate the occurrence of postoperative suture fragments in tissue. As an uncoated suture, DemeDAC™ maintains a higher coefficient of friction, contributing to secure knot tying.
Minimal Tissue Reaction
Elicits a minimal acute inflammatory reaction in tissues, characteristic of a foreign body response, followed by gradual encapsulation by fibrous connective tissue.
Permanent Tensile Strength
Not absorbed in vivo; no significant change in tensile strength retention is known to occur in vivo, providing permanent structural integrity at the wound site.
Fibrous Encapsulation
Following the initial inflammatory response, the suture undergoes gradual encapsulation by fibrous connective tissue, achieving long-term stable integration at the implantation site.
DemeDAC ™ Quality Standards.
DemeTech's Polyester (braided without covering) suture is a non-absorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). High quality materials, combined with precise braiding mechanisms, nearly eliminate the occurrence of postoperative suture fragments in the tissue. As this suture is not coated, it allows for extreme ease of use and secure knot tying.
Extreme Ease of Use
As Polyester braided without covering is not coated, it allows for extreme ease of use during the procedure, giving surgeons intuitive handling and confident placement.
Secure Knot Tying
The uncoated construction provides secure knot tying with flat, square ties, minimising the risk of knot slippage and supporting reliable long-term wound closure.
Minimal Breakage
Provides for minimal breakage, eliminating the need to remove irritating suture fragments postoperatively and reducing the risk of additional procedural intervention.
Higher Coefficient of Friction
As the suture is uncoated, it maintains a higher coefficient of friction as it passes through tissue, contributing to more controlled placement and secure fixation.
Minimal Post-Operative Fragments
High quality materials combined with precise braiding mechanisms nearly eliminate the occurrence of post-operative suture fragments in the tissue.
USP & FDA Compliant
Meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Sutures and meets FDA requirements for exempt color additives for polyester sutures.
Indications & Precautions.
Usage Indications
- Do not resterilize. Discard open, unused sutures.
- As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.
- Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing DemeDAC™ for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
- Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.
- Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.
- This product is not approved in Europe to be used on the heart or with the central circulatory and central nervous system.
Safety Precautions
- In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.
- Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.
- Adverse Reactions: Adverse effects associated with the use of this device include: wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced bacterial infectivity, minimal acute inflammatory tissue reaction, pain, edema, and erythema at the wound site.
Let’s Build Future Together.
