Absorbable sterile surgical suture
DAMADIOXANONE suture is synthetic absorbable sterile surgical suture. It is composed of polymers made from 100% homo polymer of polydioxanone. It is Monofilament sutures dyed or undyed.
DAMADIOXANONE suture is non-antigenic, non-pyrogenic and elicits only a mild tissue reaction during the absorption process, and is completely absorbed in 180-240 days. The In vitro retention of strength is 75% in four weeks.
DAMADIOXANONE suture complies with the requirements of the United States pharmacopoeia U.S.P. and European pharmacopoeia Ph. Eur. and European Medical Device Directive 93/42/EEC.
DAMADIOXANONE suture is indicated for use in general soft tissue approximation and ligation, including use in pediatric cardiovascular tissue and ophthalmic surgery. It is also particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
DAMADIOXANONE is not for use in microsurgery, adult cardiovascular or neural tissues.
DAMADIOXANONE suture, being absorbable, should not be used where prolonged approximation of tissue under stress is required (beyond six weeks), or in conjunction with prosthetic devices, i.e., heart valves or synthetic grafts.
The safety and effectiveness of Polydioxanone have not been established in neural tissue, adult cardiovascular tissue or for use in microsurgery.
Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing DAMADIOXANONE suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Users should consider the in vivo performance when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing.
The use of supplemental non absorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support.
As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation.
As an absorbable suture, DAMADIOXANONE suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
Discard opened packages and unused sutures.
Do not re-use.
Do not re-sterilize.