DemeQUICK ™ (Rapid Absorbable)

Suture Material

DemeQUICK (Rapid Absorbable) Surgical Suture is a coated, braided synthetic absorbable suture, composed of copolymers

made from 90% glycolide and 10% L-lactide. DemeQUICK (Rapid Absorbable) Surgical Suture is coated with a copolymer

made from glycolide L-lactide and calcium stearate, it is available colorless or violet from sizes: USP 6-0 to USP 2.

INTENDED USE

DemeQUICK (Rapid Absorbable) Surgical Suture is indicated for use in superficial soft tissue approximation (i.e., mucosa and skin)

where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Surgical Suture is not intended for use in

ligation, cardiovascular, ophthalmic or neurological procedures.

ACTIONS

DemeQUICK (Rapid Absorbable) Surgical Suture elicits a minimal acute inflammatory reaction in tissues, which is followed by

gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of

DemeQUICK (Rapid Absorbable) Surgical Suture occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic acids

which are subsequently absorbed and metabolized by the body. Absorption begins as a loss of tensile strength without appreciable loss of mass.

Implantation studies indicate that DemeQUICK (Rapid Absorbable) Surgical Suture absorption is essentially complete in approximately 40 days.

Characteristics

• DemeTECH’S Rapid Absorbable sutures give the best characteristics of both natural and synthetic sutures, allowing for the low infection rate of

a synthetic suture, while providing quick absorption and high tensile strength of collagen sutures (catguts).

• Rapid Absorbable is coated to allow for smooth passage through tissue.

• Clinical trials have shown that after 5 days post implantation, 50% of DemeTECH’S Rapid absorbable initial strength remained. At 10-14 days

post-implantation,approximately 0% of DemeTECH’S Rapid Absorbable linear tensile strength remained.

PRECAUTIONS

• Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.

• Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.

Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with absorption.

• When handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to

the application of surgical instruments such as forceps or needle holders.

• DemeQUICK (Rapid Absorbable) Surgical Suture knots must be properly placed to be secure. Adequate knot security requires the accepted

surgical technique of flat and square ties with additional throws as warranted by surgical circumstances and the experience of the surgeon.

The use of additional throws may be particularly appropriate when knotting monofilaments.

• To avoid damaging needle points and swage areas, the needle, 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.

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

• Avoid prolonged exposure to elevated temperature.