Politer is a braided, non-absorbable, silicone coated, sterile suture material made of polyester (Polyethylene terephthalate). The suture is prepared by braiding very fine filaments and then by coating with silicone mixture.
Pledgets, as accessories to sutures, are non-absorbable, undyed fabric precut pieces made of polytetra-fluoroethylene (PTFE).
Politer meets all requirements for non-absorbable surgical sutures specified by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).
Politer is indicated for use in general soft tissue approximation and/or ligation including use in
cardiovascular, orthopedic, general, neurological and ophthalmic surgery procedures.
Sutures are for single use only.
Pledgets are used as a pad between the suture area and the tissue surface to increase the load bearing area.
Politer elicits a minimal acute inflammatory reaction in tissue, followed by a gradual encapsulation of the suture by fibrous connective tissue. Implantation studies in animals show no significant decline in polyester suture strength over time. Both polyester fiber suture material and coating are pharmacologically inert.
Politer is supplied in USP sizes 6/0 lo 5 (EP 0.7 - 7) in boxes of 12 pouches.
Needled polyesters can be supplied with or without PTFE pledgets with varying sizes and geometry. Non-needled polyester sutures are available in a variety of precut sizes.
The product should be kept dry and clean. Keep away from direct sunlight. Do not use products after expiry (“use by”) date.
Users should be familiar with surgical procedures and techniques involving non-absorbable sutures before employing Politer for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Do not re-sterilize.
This device is single use. Known hazards with reuse or re-sterilization of opened/original packages of the device are cross contamination, infection and trauma.
Discard opened packages and unused sutures.
Do not use opened or damaged products.
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. Acceptable surgical practice should be followed for the management of infected or contaminated wounds.
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
As with any suture material, adequate knot security requires the accepted surgical technique of flat and
square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.
To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half
(1 /2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.
Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.
Discard used needles in " sharps" containers.
Do not use expired products.
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, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Although rare, inflammatory foreign-body reaction to PTFE may lead to granuloma. Infection of the cardiac suture line after left ventricular surgery maybe associated with infection of pledgets used at the cardiac line and possibly pseudoaneurysms of the left ventricle contiguous with the suture line. PTFE pledget may migrate in case of broken suture. The use of PTFE pledgets is associated with a risk of symptomatic pledget erosion, with critical life threatening cardiovascular symptoms (including possible complications; PTFE embolism, dysphagia, recurrent symptomatic gastroesophageal reflux, chest pain, melaena, arrhythmia, and bleeding). Broken needles may cause complications in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of blood borne pathogens