PTFE Sutures

PTFE Sutures Ideal suture for dental surgery Non-absorbable PTFE Monofilament Suture

Challenge Optimizing suturing in soft tissue approximation

Suture choice plays an important part in achieving an optimal soft tissue approximation, particularly where reduced capsule formation, inflammation and suture hole leakage are key considerations

With Omnia PTFE Sutures dentists can reach the goal

Product features Needle terminology

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Chord Length - Straight line distance from the point of a curved needle to the swage.

Needle Length - Distance measured along the circumference of the needle, from the point to the swage.

Needle Shapes - Different surgeries or surgical techniques demand different needle shapes. Needles are available in the following shapes: straight, bicurve, 1/8 circle, 1/4 circle, 3/8 circle and 1/2 circle.

Point The sharpened part of the needle that first penetrates the tissue.

Radius Distance from the center of an imaginary circle that would be formed by the needle if it were round. The radius is measured to the middle of the needle wire.

Swage Connection point of the suture and the needle. Micro teeth grip the suture material and prevent it from slipping out.

Wire Diameter Gauge or thickness of the needle wire originally used to form the needle body

Product features Type of needles

Sharp tip - Sharp body The HS needle is also known as “triangular” needle, since it has cutting edges on the sides and outer curve. Due to its cutting edges, this needle easily penetrates tissues and is suitable for almost all uses. It provides an excellent penetration capacity and great solidity, and is fit for sutures with periosteum incision and in case of thick mucosa Diamond tip - Round body The HRT needle has a quadrangular pyramid-shaped point and a round body. This particular shape allows any easy penetration of soft tissues without causing lacerations, and preventing the needle from rotating in the needle-holder.

This needle is appreciated and suitable for oral surgery

Extra Sharp tip – Sharp body The Extra Sharp tip has two cutting surfaces, a triangular body, and guarantees high cutting performance. The needle is small, very sharp and requires little pressure during surgery. It maintains a optimal longlasting cutting capacity

Product features NEEDLE TIP - curve

The needle has a predictable path through tissue and requires less space for maneuvering than a straight needle. The semicircular path is the optimal course for sutures through tissue and provides an even distribution of tension.

Body curvature is commonly: Three eighths circle: The 3/8 needle allows the clinician to pass from the buccal surface to the lingual surface in one motion. Is used most commonly for skin closure.

-Half circle .

The 1/2 circle needle is traditionally used in more restricted areas; for instance, in the buccal of the maxillary molars and the facial aspect of the maxillary and mandibular incisors.

The 1/2 circle needle is routinely used for periosteal and mucogingival surgery.

Product features SUTURE SIZES

Sutures come in various sizes. The bigger the suture material, usually the bigger the needle. The bigger the number, the smaller the size of the suture.

Suture sizes range from 00 (very large, used to close the abdominal wall—about the size of large fishing line) to 10-0 (very tiny, used for microvascular anastomoses—as fine as a human hair).

You generally will use sizes in the middle range: 3-0 to 5-0.

On areas where cosmetic concerns are less important, 3-0 or 4-0 sutures are best, because the larger size makes the technique easier and the thicker sutures are stronger.

Product features Products range

What is a PTFE Suture Description PTFE Suture, is a sterile non absorbable monofilament surgical suture made from polytetrafluoroethylene (PTFE) polymer, designed specifically for oral surgery.

PTFE is a unique synthetic material that it is inert and chemically nonreactive. In addition, the monofilament construction prevents bacterial wicking which is associated with braided sutures.

Unlike other synthetic monofilament sutures, such as nylon, the material is supple and well tolerated in the mouth. The handling, knottying, and knot-holding characteristics of our PTFE suture are excellent as well.

PTFE sutures are used for soft tissue approximation and /or ligation, including dental and general surgeries but it is not indicated for use in cardiovascular surgery, ophthalmic surgery, micro surgery and neural tissue.

Why a PTFE Suture?

Properties of PTFE thread - Its unique softness and smoothness enables it to go through soft tissues minimizing micro- damage reaction around tissue duct, which prevents from bacterial colonization in deeper layers of the wound.

-The thread does not retain the coiled shape after unpacking, which makes it easier to work with.

- The surgical knot made with a PTFE suture is durable and does not loosen. The ends of the suture do not cause irritation of the cheek, lips and tongue, unlike suture materials based on various monofilament fibres, which additionally may contribute to the formation of viral changes on mucous membrane.

- In contrast to braided sutures, especially those made from absorbable materials, PTFE does not absorb blood, saliva, bacteria and food residues. That promotes wound healing per primary intention.

- Despite its soft and delicate nature, PTFE firmly supports tissues during the whole healing process, in contrast to absorbable materials which maintain tissues only in the early stages of healing due to the presence of enzymes in the mouth.

Efficiency Key advantages •Non-absorbable, •Monofilament construction •Biologically inert and chemically non-reactive •Not subject to weakening by tissue enzymes •Little or no package memory •Excellet soft tissue response •Soft for patient •High tensile strength

Material Biocompatible, according with ISO 10993-1, we carried out: In vitro cytotoxicity Intracutaneous reactivity Skin sensitization

Keeps the surgical site reliably closed eliminates bacterial wicking 100% Medical Grade PTFE soft handling and knots securely does not weaken when moistened increased patient comfort - not stiff like most monofilaments

Efficiency Application PTFE sutures thanks to being completely non-absorbable and biologically inert, cause minimal inflammatory response in the moist environment of the oral cavity, that’s why they are an excellent choice for any: •Dental Bone grafting procedures •Soft tissue grafting •Guided tissue regeneration •Implant surgery •Periodontal surgery •Ridge aumentation

Competitors (110 $) •Osteogenix - Cytoplast®

- $100.00 (12 sutures per box)

Important to remember The PTFE sutures are containing a certain amount of air. Due to this they don’t follow the traditional USP classification. Referring to the USP traditional classification reported on the package, we have to expect to have at the end a final diameter that is inferior if compared with the same thread of the same code.

Let’s consider a diameter USP 3-0 if we desire a thread d USP 4-0 ,or a USP 4-0 if we want a USP 5-0.

High Quality Legislation Experience As a worldwide producer in Custom Sterile Procedure kits, we are committed to quality. Omnia has been providing Sutures to dental clinics for over 20 years

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Legislation 1.

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The production of Omnia’ s sutures is classified in a controlled environment “ISO Class 8� in accordance to EN ISO14644-1.

Our sutures are devices produced incompliance with the rules of Directive 93/42/EEC concerning medical devices(updated and amended by Directive 2007/47/ EC) and the requirements of UNI EN ISO 13485:2012.

The sutures are packed in blister of medical paper and plastic film in accordance with very strict and rigorous procedures, in order to respond to the highest requirement microbial and particulate level.

The sutures are supplied in sterile and single used packaging, sterilized using ethylene oxide according to ISO 11135-1 The sutures are in compliance with technical standards: 1. USP <861> suture diameter: measure of the precision of real diameter respect the declared value -> to assure to the surgeon the expected dimensions and functionality 2. USP <871> suture-needle attachment: measure of the attachment force from needle to wire > to assure the expected resistance during use 3. USP >881 tensile strength - to assure the expected effectiveness in ligation and approximation

High Quality

Manufacturing process flow chart and controll steps to assure the conformity of the batches

Superior Service The packaging for PTFE Suture is designed with ease of use in mind.

For the majority of the part numbers, needle visibility through the package allows product confirmation before opening the pouch. Slotted needle grips allow for rapid arming of the needle without snagging or knotting of the thread.

Needle point tipe Needle drawing

Suture material

USP size (metric size)

Poduct code

Thread length Symbols for: read instruction for use and do not reuse Notified body/ authorization number

Brand name

Needle length Needle curving

Supplied sterile using ethylene oxide

Why offer Omnia PTFE Sutures?

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Largest variety of PTFE offered Great needles Excellent needle penetration capacity and smooth surface Biologically inert and very soft Cost effective

Common questions on PTFE Sutures?

What kind of knot do you recommend for securing PTFE sutures?

A double throw, followed by a locking stitch in the opposite direction, and then a second locking stitch in the opposite direction of the first locking stitch.

How long can the sutures be left in place?

While this is left to the discretion of the surgeon, most clinicians find that the sutures may be left in place for 2 to 4 weeks because of the biocompatibility of PTFE and the maintenance of tensile strength.

What is the shelf life of PTFE sutures?

4 years from the date of manufacture. The expiration date is printed on the box and on each individual suture pouch.

OMNIA – CYTOPLAST COMPARISON

Suture Ref:

Material

Wire Lenght

Needle Lenght

Needle Shape

OMNIA

-

-

-

-

-

CYTOPLAST

CS-0418

PTFE 2/0

45 cm

19 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3130

PTFE 3/0

75 cm

19 mm 3/8 Circle

Reverse Cutting Needle

CYTOPLAST

CS-051819

PTFE 3/0

45 cm

19 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

-

-

-

-

-

CYTOPLAST

CS-0518

PTFE 3/0

45 cm

16 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3141

PTFE 4/0

75 cm

16 mm 3/8 Circle

Reverse Cutting Needle

CYTOPLAST

CS-0618 RC

PTFE 4/0

45 cm

16 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

-

-

-

-

-

CYTOPLAST

CS-0618 Perio

PTFE 4/0

45 cm

13 mm 1/2 Circle

Taper Point Needle

Price per Box Europe

USA

-

-

Packaging 12 pcs per box 12 pcs per box

132 €

12 pcs per box -

-

12 pcs per box 12 pcs per box

132 €

12 pcs per box -

-

12 pcs per box

OMNIA

-

-

-

-

-

CYTOPLAST

CS-0618 Premium

PTFE 4/0

45 cm

13 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3150

PTFE 5/0

75 cm

12 mm 1/2 Circle

Reverse Cutting Needle

CYTOPLAST

-

-

-

-

-

-

12 mm 3/8 Circle

Reverse Cutting Needle

132 €

-

-

12 pcs per box 12 pcs per box

132 €

OMNIA

32.Z3151

PTFE 5/0

75 cm

CYTOPLAST

-

-

-

-

-

-

OMNIA

32.Z3160

PTFE 6/0

75 cm

11 mm 1/2 Circle

Reverse Cutting Needle

132 €

CYTOPLAST

-

-

-

-

-

-

OMNIA

32.Z3240

PTFE 4/0

75 cm

18 mm 3/8 Circle

Diamond Needle Tip

132 €

CYTOPLAST

-

-

-

-

-

-

OMNIA

32.Z3250

PTFE 5/0

75 cm

18 mm 3/8 Circle

Diamond Needle Tip

132 €

CYTOPLAST

-

-

-

-

-

-

OMNIA

32.Z3260

PTFE 6/0

75 cm

10 mm 1/2 Circle

Diamond Needle Tip

132 €

CYTOPLAST

-

-

-

-

-

-

-

12 pcs per box

-

12 pcs per box

-

-

-

-

-

-

-

-

17

OMNIA – GORE COMPARISON

Suture Ref:

Material

Wire Lenght

Needle Lenght

Needle Shape

OMNIA

32.Z3150

PTFE 5/0

75 cm

12 mm 1/2 Circle

Reverse Cutting Needle

GORE

P5K17A

PTFE 5/0

61 cm

16 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3151

PTFE 5/0

75 cm

12 mm 3/8 Circle

Reverse Cutting Needle

GORE

P5K23A

PTFE 5/0

61 cm

18 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3141

PTFE 4/0

75 cm

16 mm 3/8 Circle

Reverse Cutting Needle

GORE

P4K13A

PTFE 4/0

61 cm

18 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3260

PTFE 6/0

75 cm

10 mm 1/2 Circle

Diamond Needle Tip

GORE

P6K23A

PTFE 6/0

61 cm

13 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3160

PTFE 6/0

75 cm

11 mm 1/2 Circle

Reverse Cutting Needle

GORE

P6K25A

PTFE 6/0

61 cm

16 mm 1/2 Circle

Reverse Cutting Needle

OMNIA

-

-

-

-

-

GORE

P7K13A

PTFE 7/0

61 cm

11 mm 3/8 Circle

Reverse Cutting Needle

OMNIA

32.Z3130

PTFE 3/0

75 cm

19 mm 3/8 Circle

Reverse Cutting Needle

Price per Box Europe 132 €

USA

Packaging 12 pcs per box

12 pcs per box

132 €

12 pcs per box

12 pcs per box

132 €

12 pcs per box

12 pcs per box 132 €

12 pcs per box 12 pcs per box

132 €

12 pcs per box

12 pcs per box -

12 pcs per box

132 €

12 pcs per box

GORE

-

-

-

-

-

-

-

OMNIA

32.Z3240

PTFE 4/0

75 cm

18 mm 3/8 Circle

Diamond Needle Tip

132 €

12 pcs per box

GORE

-

-

-

-

-

-

-

OMNIA

32.Z3250

PTFE 5/0

75 cm

18 mm 3/8 Circle

Diamond Needle Tip

132 €

12 pcs per box

GORE

-

-

-

-

-

-

-

18