Descripción del producto

DESCRIPTION:

EGY- PDS is a sterile synthetic absorbable monofilament suture based on  Poly (p-dioxanone). EGY-PDS are available dyed violet D&C#2 (CI ****5) and undyed. EGY- PDS complies with the requirement of USP and EP.

INDICATIONS:

EGY- PDS sutures are intended for use in general soft tissues approximation including pediatric cardiovascular tissues, ophthalmic surgery and microsurgery. These sutures are identical when extended wound support needed (more than six weeks) while absorbable suture is desirable.

APPLICATION:

Depending on patient condition, wound size and surgeon experience, needle and suture size can be selected

PERFORMANCE:

EGY- PDS sutures elicits a minimal tissue reaction and in growth of fibrous connective tissue.

Absorption occurs by means of hydrolysis, where the polymer degrades to the monomeric acid *-hydroxyethoxyacetic acid which is subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile strength and end by a total loss of mass

 Note: Complete absorption will be essentially done after  **7 months. Above percents are averages with respect of  USP size difference 

CONTRAINDICATIONS:

As all absorbable suturesEGY- PDSis contraindicated where extended approximation of tissue under stress is required or in conjunction prosthetic devices e.g. heart valves or synthetic grafts.

WARNINGS & PRECAUTIONS:

Under certain circumstances, notable procedures, immobilization of joints by external support may be employed at the discretion of surgeon. The safety  and effectiveness of EGY-PDS has not been established in contact with the central nervous system, adult cardiovascular tissues or in large vessels.

Each USP size has its upper limits tensile strength (USP and EP); over stretch above this limits may lead to suture damage.

Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.

As with any foreign body, prolonged contact of any suture with salt solution such as found in biliary and urinary tracts, may cause calculus formation.

EGY- PDS sutures require the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstances and the experiences of the surgeon. Conjunctival, cuticular, and vaginal epithelium sutures which remain in place longer than *0 days may cause localized irritation and should be snipped off or removed. Subcuticular sutures should be placed as deeply as possible to minimize the erythema and indurations normally associated with the absorption process.

Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as sutures extrusion and delayed absorption may occur.

This suture may be inappropriate in elderly, malnourished, debilitated patients, or in patients suffering from conditions which may delay wound healing.

When handling this or any other suture material, care should be taken to avoid damage during the application