Page 1

Biomaterials

REGUARDETM Resorbable Collagen Membranes

BioResorb® Macro Pore Bone Regeneration Material

KontourTM Adapt Resorbable Collagen Membranes

DirectOssTM Natural Bovine Bone Substitutes

ViletTM Resorbable Sutures Vilet II QuickTM Resorbable Sutures

DirectFlon® Surgical Sutures


Biomaterials

BioResorb® Macro Pore: Bone Regeneration Material

3

DirectOssTM: Natural Bovine Bone Substitutes

6

REGUARDETM: Resorbable Collagen Membranes

8

KontourTM Adapt: Resorbable Collagen Membranes

10

DirectFlon®: Surgical Sutures

12

ViletTM and Vilet II QuickTM: Resorbable Sutures

16

2


BioResorb® Macro Pore

Helps Create Bone ß-Tricalcium Phosphate Bone Regeneration Material with Advanced Porosity BioResorb® Macro Pore is an osteoconductive, pure-phase ß-Tricalcium phosphate bone grafting material developed via a patented process that creates a porous structure most similar to human bone. The interconnecting micro & macro porous structure gives the advantage of allowing vascularization and cell transport into and throughout the particle, leading to new bone deposits within the particles themselves. This results in highly-predictable bone formation.

Lateral wall sinus elevation. 100% BioResorb® mixed with blood

Histology at 7 months – improved bone regeneration with a high activity of osteoblasts, homogenous cortical structures and no signs of inflammation.

Biopsy taken at 7 months.

“Our results with BioResorb® – without a combination of autologous bone – are predictable and uncomplicated for the patient. Our histologic research has confirmed the excellent osteoconductive properties of this material.” Achim Schmidt, DDS Munich, Germany

3


BioResorb® Macro Pore Why BioResorb®? Interconnecting Porosity for Predictability The open and interconnecting porosity of BioResorb® granules enable bone growth throughout the complete particle, unlike the icing effect of bone that occurs in less porous materials. The micropore sizes range from 0.5 10μm, while the macropore sizes are 50 - 700μm. This unique combination closely mimics the porous structure of human bone and leads to predictable bone formation. Advanced Osteoconductivity The advanced chemical structure of BioResorb® ß-TCP granules facilitates the rapid formation of osteoblasts – the precursor to osteogenesis. BioResorb® Macro Pore not only offers advanced osteoconductivity, it is also osteotropic due to the high calcium ion composition.

SEM magnification x 100 of BioResorb® Macro Pore

Resorption As with all materials, the rate of bone remodeling is patient and site dependant. However, the resorption rate of BioResorb® Macro Pore has proven similar to the rate of new bone growth. The ß-TCP resorbs simultaneously with the formation of new, natural bone within the augmentation site. Biocompatible ß-Tricalcium phosphate has been shown to be 100% biocompatible in numerous studies. There have been no unfavorable tissue reactions or immunologic reactive rejections. In a properly prepared recipient site, BioResorb® Macro Pore displays very high integration to the host bone without any soft tissue encapsulation or pathological reactions.

Odontogenic keratocyst

Hydrophilic The highly-porous BioResorb® granules are extremely hydrophilic, resulting in a very cohesive and easy to handle material after hydration. This allows for the graft to be placed in defects of any size and shape with relative ease.

“I have found BioResorb® to provide the most predictable results. Because of the advanced porosity, I can mix the particles with the patients’ own blood and create an osteoinductive graft without using autogenous bone.” Dennis Smiler, OMS Encino, CA 4

SEM magnification x 10,000 of BioResorb® Macro Pore

6 months after cyst removal and placement of BioResorb® Macro Pore. Complete restitution of bone structure.* *SOURCE: Goran Kneževic´; Radiological Evaluation of the Healing of Bone Defects Filled with BioResorb®; Acta Stomotol Croat. 2007;41(1):66-73


BioResorb® Macro Pore Granule Size

BioResorb® Macro Pore is available in various granule sizes to meet every indication

Granule size

Vial Contents

Ref. No.

200 – 500 µm

1 x 0,5 ml

19002105

500 – 1000 µm

1 x 0,5 ml

19005105

1 x 1,0 ml

19005110

1 x 2,0 ml

19005120

200 – 500 µm

5 x 0,5 ml

19002505

500 – 1000 µm

5 x 0,5 ml

19005505

5 x 1,0 ml

19005510

5 x 2,0 ml

19005520

1 x 1,0 ml

19014110

Set

Sinus lift 1400 – 3200 µm

5


DirectOss™ Natural bovine bone substitute for dental surgery Anorganic cancellous bone graft granules

100% Natural Safe, Biocompatible Highly Purified Large Inner Surface Area Multi-Porosity Natural DirectOssTM is a natural hydroxyapatite extracted from bovine cancellous bone. Safe This bovine bone has been harvested from herds in Australia (which has historically been BSE free) and processed in accordance to EN ISO 22442-2. Each animal undergoes a pre and post-mortem health inspection and then only extremity bones are used from each animal. Purified DirectOssTM undergoes a proprietary multi-step purification process that removes organic content from the bone. This process results in DirectOssTM being chemically and structurally comparable to mineralized human bone (nanocrytalline natural apatite). In addition, DirectOssTM has been shown to be biocompatible and has been terminally sterilized to an SAL of 10 -6.

Protein Analysis Comparison Crude Protein (%) DirectOss™

Bio-Oss®* Pure Protein (0.062%)

0.04%

Collagen (0.05%)

0,118% (≈0.12%)

Others (Nitro Comp.) (0.006%) Ref. NuOss®*, a Bone Grafting Material for Oral Surgery: A Comparative Study with Bio-Oss®* by Collagen Matrix Inc. Ref. Biomaterials 2001; 22:1005-1012

DirectOssTM Ca (wt.%)

P (wt.%)

Ca (at.%)

P (at.%)

Ca/P ration

39.67

19.55

0.99

0.63

1.57

Large Inner Surface Area An additional benefit provided by this interconnected porous structure is that if provides DirectOssTM with a larger surface area than some comparable products currently in the market. This provides for additional area to support new bone deposits while also making DirectOssTM a highly hydrophilic grafting material. 6

* Registered Trademarks of Geistlich and Ace Surgical Supply Co., Inc.


DirectOss™ Multi-Porosity This proprietary process results in DirectOssTM having a structure comprised of a combination macropores, mesopores and micropores. The advantage of this 3 dimensional interconnected highly porous structure is that it allows for vascularity and cell transport into and through out this structure. This then allows for proliferation of new bone growth throughout each granule of DirectOssTM.

Granules

MacroPore (>100μM)

MicroPore (<100μM)

BET (Surface Area) Comparison

100 80

20

Inner Surface Area (m2/g) NuOss®*

40

Bio-Oss®*

60

DirectOss®

Inner Surface Area (m2/g)

MesoPore (10-100μM)

0

Ref. NuOss®*, a Bone Grafting Material for Oral Surgery: A Comparative Study with Bio-Oss®* by Collagen Matrix Inc. Ref. Biomaterials 2001; 22:1005-1012

DirectOss™

Bio-Oss®*

NuOss®*

88.2

79.7

57.0

Products

Applications Reconstruction of oral and maxillofacial defect (alveolar ridge, periodontal defects, filling of extraction sockets, and maxillary sinus floor, etc.)

Case courtesy of Dr. Pedro Peña (Madrid, Spain)

Granule Version

Syringe Version

Granule size

Weight

Reference#

Granule size

Weight

0.25-1.0mm 0.25-1.0mm 0.25-1.0mm

0.25g /0.54CC

DXCA251025

0.25-1.0mm

0.25cc syringed

DXCA251025S

0.50g /1.08CC

DXCA251005

0.25-1.0mm

0.5cc syringed

DXCA251005S

1.0g /2.15CC

DXCA251010

0.25-1.0mm

1.0cc syringed

DXCA251010S

1.0-2.0mm

0.50g /2CC

DXCA102005

0.25-1.0mm

2.0g/4.24CC

DXCA251020

1.0-2.0mm

2.0g/4.24CC

DXCA102020

* Registered Trademarks of Geistlich and Ace Surgical Supply Co., Inc.

Reference#

7


REGUARDETM Resorbable Collagen Membranes for Dental Surgery

Type I Bovine Collagen Matrix Indicated For Use in Guided Tissue Procedures to Enhance Wound Healing REGUARDETM Collagen Membranes are resorbable, cell-occlusive barrier membranes used in guided tissue and bone regeneration procedures in oral surgery to manage oral wounds and assist in wound healing. They are commonly used in periodontal surgery as well as dental implant, bone defect, and ridge augmentation procedures. The membranes are manufactured from highly purified type I collagen and have characteristics specifically designed to meet the needs and preferences of the patient and clinician.

Features • Higher mechanical strength for membrane stabilization in situ using either sutures or resorbable tacks • Longer in vivo stability and resorption time, 26 - 38 weeks, for sustained function • Optimized flexibility and rigidity for better space maintenance, which allows for desired tissue in-growth • Either side of the membrane can be placed towards the soft tissue or bone • Easily trimmed and placed, wet or dry • Highly purified type I collagen fibres derived from bovine Achilles tendon • Gamma irradiated to sterilise • Nonpyrogenic • Cell occlusive - retards epithelium down growth • Macromolecular pore size allows nutrient transfer

8


REGUARDETM

Available in 3 Convenient Sizes

Membranes Per Box

BIOMATERIALS

REGUARDETM

Ref. No.

15 mm x 20 mm

2

16001520

20 mm x 30 mm

2

16002030

30 mm x 40 mm

2

16003040

Preis

Test Suture Pull-Out Strength (g) Pore Structure In vivo Resorption (weeks)

ReguardeTM

Biomend®

350 ± 80

74 ± 10*

Permable to CA 0.004 µm* 27

Dependable Resorption Rate

Area (mm2)

Characterization of Collagen Membranes

4-8* Implementation time (week)

*Reported from 510K (K924408 © 2000 Society for Biomaterials

9


KontourTM Adapt Resorbable Collagen Membrane

Natural Easy of Use Sustained Protection Natural KontourTM Adapt is made from a single layer of purified porcine peritoneum collagen rich tissue Purified Proprietary process assures the membranes are highly biocompatible resulting in minimal inflammation and foreign body response Performance/ Characterization Parameter

Porcine Collagen Membrane

Bio-Gide®

Hydroxyproline Content (Weight %)

11.7 ± 1.1%

11.8 ± 0.8%

Suture Pull-out Strength

953 ± 110 g

330 ± 120g

Conformability

Highly

Highly

3.5

3.0 Bio-Gide®* Kontour™ Adapt

3.0

Bio-Gide®* Kontour™ Adapt

2.5

2.5

Giant Cells Score

2.0

2.0 1.5 1.0

1.5 1.0 0.5

0.5

0.0

0.0

- 0.5

- 0.5 4 Weeks

8 Weeks

12 Weeks

16 Weeks

4 Weeks

8 Weeks

12 Weeks

16 Weeks

Easy of Use • Either side of membrane may be placed against wound; does not require a specific orientation for use • May be placed either dry or hydrated • Does not cling to instruments or gloves when hydrated • Easily conforms to defects and contours • Can be easily repositioned once placed • Has excellent strength to support tacking or suturing

10


KontourTM Adapt Resorbable Collagen Membrane

100

100 80

80

60

60

40

40

20

20

0

Supports Wound Healing New host collagen is regenerated as membrane resorbs

0

4

8

12

% New Collagen

Sustained Protection • Initial slower rate of resorption protects wound during early critical period of wound healing • Protects wound from undesired in-growth of soft tissue • Provides an effective barrier function for up to 12-16 weeks

% Implant Remaining

Implant Remaining New Collagen

0

Time (Weeks) Figure 1. Plot of % implant remaining and % new collagen for Kontour™ Adapt

Description Kontour Adapt Membrane 15x20mm

KRMA2030

Kontour Adapt Membrane 20x30mm

KRMA3040

Kontour Adapt Membrane 30x40mm

15x20mm 20x30mm 30x40mm

100

100 Implant Remaining New Collagen

80

80

60

60

40

40

20

20

0

0

4

8

12

% New Collagen

KRMA1520

Size

% Implant Remaining

Reference#

0

Time (Weeks) Figure 2. Plot of % implant remaining and % new collagen for Bio-Gide®*

Figure 3. SEM micrograph of the PCM (side A) at 50x magnification

Figure 4. SEM micrograph of the PCM (side B) at 50x magnification

Figure 5. SEM micrograph of the PCM (cross-section) at 50x magnification * Registered trademarks of Geistlich

11


DirectFlon® PTFE Polytetrafluoroethylene (PTFE) is a nonabsorbable material of high biocompatibility which for many years has been used for production of cardiovascular surgery and membranes for guided bone regeneration. PTFE is also used for production of surgical suture.

Properties of dPTFE Thread • lts unique softness and smoothness enables it to go through soft tissues minimizing microdamage 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. • ln cantrast to braided sutures, especially those made from absorbable materials, DirectFlon® does not absorb blood, saliva, bacteria and food residues. That promotes wound healing per primam intencionem. • Despite its soft and delicate nature, DirectFlon® 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.

12


DirectFlon® ePTFE vs dPTFE Surgical sutures made from ePTFE are used mostly in vascular and cardiac surgery. Pores in ePTFE sutures are interlaced by soft tissues and vessels, so the sutures are permanently incorporated in the body. As far as wound closure in the oral cavity is concerned, this property is unnecessary - surgical sutures in the mouth are removed 7-10 days after surgery. DirectFlon® is different: it is the first smooth PTFE surgical suture (dPTFE) without micropores, which very effectively reduces dental plaque adhesion and accumulation of bacteria and food residues. lt is easy to remove due to lower capillarity. Black & White Innovative combination of a white PTFE suture with a black needle ensures excellent visibility in the surgical field. The black needle is weil visible under soft tissue. Thanks to this solution we can accurately determine the direction of the needle when it passes through the skin or mucosa. This is especially important in precise oral or plastic surgery.

Needle Mounting The way in which the needle is mounted - a smooth transition between the needle and the thread contributes to minimizing trauma of the sewed tissues. Needle Properties Choosing a partner to produce needles, we took into account years of experience, as weil as opinions of renowned surgeons. Top quality is our priority. Our surgical needles are made of high quality steel with unique chemical composition. The hardness of the steel minimizes the risk of mechanical damage to the cutting surface during surgery. Needles maintain sharp cutting surface during stitching, which ensures precision of surgery. They do not undergo distortion, even when used for deformed tissue, such as a post-operative scar.

Needle Mounting

Needle Properties

Standard in Minimally Invasive Surgery The aforementioned features of DirectFlon® surgical suture make it the most technologically advanced suture material for oral and plastic surgery.

Jaroslaw Pospiech DDS,PhD Poland

Parameters, structure and excellent needle quality of DirectFlon® PTFE suture makes it a perfect material for stiching wounds in the skin and mucous membrane areas. I use DirectFlon® with great success in augmentation, implant and periodontic surgery. Decidedly less after-treatment inflammatory complications as weil as better and faster wound healing was observed. DirectFlon® supports tissues very weil, does not loosen, increases patient comfort and reduces physical discomfort of removal the stitches to mimimum.

13


DirectFlon® Cases Clinical images of wounds in the oral cavity sutured with DirectFlon®: immediately after surgery and 7 days later. After the 7-day period the mucosa does not show signs of inflammation, wounds heal per primam intencionem. ln most cases, after a week of healing, DirectFlon® stitches can be removed.

lmmediately after surgery

14

7 days after surgery


DirectFlon®

Needle BLACK

DS ½ Circle

Needle SILVER

DS ½ Circle

DM 3/8 Circle

Needle Length

Needle Crosssections

Suture Length

13

Y

16

USP 3/0

4/0

5/0

6/0

55 cm

-

-

Y

55 cm

ID3DS165512B

ID4DS165512B ID5DS165512B

-

19

Y

55 cm

ID3DS195512B

ID4DS195512B ID5DS195512B

-

22

Y

55 cm

ID3DS225512B

ID4DS225512B

-

Needle Length

Needle Crosssections

Suture Length

13

Y

55 cm

16

Y

19 22

ID5DS135512B ID6DS135512B

-

USP 3/0

4/0

5/0

6/0

-

-

ID5DS135512S

-

55 cm

ID3DS165512S ID4DS165512S ID5DS165512S

-

Y

55 cm

ID3DS195512S ID4DS195512S ID5DS195512S

-

Y

55 cm

ID3DS225512S

-

-

13

55 cm

-

-

16

55 cm

ID3DM165512S ID4DM165512S ID5DM165512S

-

19

55 cm

ID3DM195512S ID4DM195512S ID5DM195512S

-

22

55 cm

ID3DM225512S ID4DM225512S

-

-

ID5DM135512S ID6DM135512S

-

DS: round needle with cutting blade - The needle is designed for surgical procedures where only minimal tissue traumatization is desired, but excellent penetration, better than with round needles, is still required. Provides a smooth transition between the hard tissues. DM: needle with reverse cutting blade, it has a specially designed tip - the third section of the length of the needle is sharp, while the remaining part has an oval cross-section, flattened for better grip in a vise. Thanks to its unique properties it can be successfully used in many surgical procedures.

15


ViletTM and Vilet II QuickTM Vilet™

Vilet™

Vilet II Q Vilet II Quick™

Vilet™ is a braided coated synthetic absorbable suture made from Vilet™ is a braided coated synthetic absorbable suture Vilet II Quick™ is a Vilet™ is a braided coated synthetic absorbable suture Vilet II Quick™ is a braided coated fast-abso polyglactin (PGLA) 90-10. made from polyglactin (PGLA) 90-10. suture made from 1 made from polyglactin (PGLA) 90-10. suture made from 100% polygycolic acid (PG • Maintain approximately 75-85% of its original strength at two weeks and 50-65% of its original strength at 3 weeks post implantation.* • Maintain approximately 75-85% of its original strength at • Maintain approxim • Maintain approximately 75-85% of its original strength at • Maintain approximately 60-70% of its origin • Completely resorbs in 60-90 days* two weeks and 50-65% of its original strength at 3 weeks post implantation two weeks and 50-65% of its original strength at 3 weeks post implantation.* post implantation.* • Completely resor • Completely resorbs in 42 days* Product is equivalent to Vicryl** post implantation.* • Completely resorbs in 60-90 days* • Completely resorbs in 60-90 days* Vilet II Quick™ is a braided coated fast-absorbing synthetic absorbable Product is equivalent to Vicryl** Product is Equivale Product is equivalent to Vicryl** Product is Equivalent to Vicryl Rapide** suture made from 100% polygycolic acid (PGA). • Maintain approximately 60-70% of its original strength after 1 week post implantation.* • Completely resorbs in 42 days* Both Products FeatureBoth Products Fea

• High tensile streng Needles • High tensile strength throughout the critical w • Excellent knot secu • Excellent knot security and tie down • Superb handling an 3/8 Circle • Superb handling and smooth tissue passage Reverse Cutting • Reliable/consistent • Reliable/consistent absorption profile • Meet or exceeds th • Meet or exceeds the USP & EP requirements C-3 • Race track style packaging that insures sutur • Race track style pa 13 mm • Proprietary 300 se • Proprietary 300 series needles which combin with increased nee with increased needle sharpness

Product is Equivalent to Vicryl Rapide**

Features Vilet™ and Vilet II Quick™ • High tensile strength throughout the critical wound healing period • Excellent knot security and tie down • Superb handling and smooth tissue passage • Reliable/consistent absorption profile • Meet or exceeds the USP & EP requirements • Race track style packaging that insures sutures are delivered “kink” free • Proprietary 300 series needles which combines superior ductile strength with increased needle sharpness

FS-2 19 mm

The 300 DifferenceThe 300 Difference Ductile Strength Sharper Needle Sharper Needle Suture Needles

Suture Needles 100% increase in ductility. When needle bends it is less likely to break when reshaping

Suture Needles

12% increase in penetration. Less force, less trauma.

120%

120%

100%

100%

80%

80%

Suture Needles % Strength

Ductile Strength

Sharper Needle Resorption Profile Re

% Strength

The 300 Difference Ductile Strength

60%

60%

40%

40%

20%

20%

0%

5

10

0% 14

Resorption Profile Vilet

www.i

Vilet Quick

* Times are based on su

120%

% Strength

100%

Innovation. Quality.

Innovation.

80%

Quality. Service.

60% 40% 20% 0% 5

10

14

21 Days

16

28

35-42 * Times are based on subcutaneous tissue implantation studies in rats. ** Registered trademarks of Ethicon Inc.


ViletTM and Vilet II QuickTM Vilet™ Item #

Size (USP)

Length

Color

Needle Type

V385U

5-0

18”

Undyed

C-3

V386U

4-0

18”

Undyed

C-3

V392U

4-0

18”

Undyed

FS-2

V392

4-0

18”

Violet

FS-2

V393U

3-0

18”

Undyed

FS-2

V393

3-0

18”

Violet

FS-2

Item #

Size (USP)

Length

Color

Needle Type

VGQ386

4-0

18”

Undyed

C-3

VGQ392

4-0

18”

Undyed

FS-2

Needle Shape 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm

QTY/Box 12 12 12 12 12 12

Vilet II Quick™ Needle Shape 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 19mm

QTY/Box 12 12

Cross Reference Chart Implant Direct Reference #

Suture Material

Needle Type

Ethicon* Reference #

Look* Reference #

Hu-Freidy* Reference #

V385U

Undyed PGLA 90-10

5-0

18”

C-3

J493G

493B

PSN493V

V386U

Undyed PGLA 90-10

4-0

18”

C-3

J494G

494B

PSN494V

V392U

Undyed PGLA 90-10

4-0

18”

FS-2

J422G

422B

PSN302V (violet)

V392U-S2

Undyed PGLA 90-10

3-0

18”

FS-2

J423G

423B

PSN303V (violet)

VGQ386

Undyed PGA

4-0

18”

C-3

VR494

-

PSN510FA (violet)

VGQ392

Undyed PGA

4-0

18”

FS-2

VR496

-

PSN525FA (violet)

Implant Direct Reference #

Ethicon* Reference #

Look* Reference #

Hu-Freidy* Reference #

FS-2

FS-2

C6

C6

C-3

P3

C3

C3

Suture Size Suture Length (USP)

* Registered trademarks of Ethicon Inc., Look and Hu-Freidy

17


FAQ What are ViletTM and Vilet II QuickTM sutures made from? Vilet is a coated synthetic absorbable suture made from polyglactin (PGLA) 90-10. This Product is equivalent to Vicryl*. Vilet II QuickTM is a coated fast-absorbing synthetic absorbable suture made from 100% polygycolic acid (PGA). This Product is equivalent to Vicryl Rapide*. What is the absorbtion rates for ViletTM and Vilet II QuickTM sutures?

What are the benefits of advantages of using PGLA 90-10 and PGA sutures? Both PGLA 90-10 and PGA are known for maintaining a high tensile strength during the critical wound healing period (as compared to gut and chromic gut sutures). Furthermore, these materials are viewed as being both soft and being able to glide through tissues easily. Finally, PGLA 90-10 and PGA sutures have been shown in studies to elicit less tissue reaction as compared to gut and chromic gut sutures.

ViletTM sutures absorbtion rates**

What kind of knot do you recommend for securing ViletTM and Vilet II QuickTM sutures? It is recommended that the clinician use a multi-throw surgical knot technique for both ViletTM and Vilet II QuickTM sutures.

Days

Approximate % Tensile Strength Retained

14 21 28 35 - 42 60 - 90

81% 58% 25% 0% Totally Absorbed

Vilet II QuickTM sutures absorbtion rates** What are the values associated with each USP designation? USP Size

Suture Diameter (mm)

Knot Pull Tensile Strength (N)

4-0 5-0

0.15 0.10

9.32 6.67

Note: Both ViletTM and Vilet II QuickTM sutures have been rated per USP designation based on Tensile Strength only (and not suture diameter size).

What are the needles sizes and curvatures based on?

Days

Approximate % Tensile Strength Retained

5 10 14 42

Retained 67% 56% 17.4% Totally Absorbed

size = distance along the curvature of the needle

Needle Curvature

1/2 Circle

3/8 Circle

1/4 Circle

What types of Needles are available with ViletTM and Vilet II QuickTM sutures? Both ViletTM and Vilet II QuickTM are offered with a FS-2 needle (3/8 Circle w/ Reverse cut -19mm) and a C3 needle (3/8 Circle w/ Reverse cut -13mm).

5/8 Circle

Straight

Reverse cut

Can ViletTM and Vilet II QuickTM sutures be resterilized? No, ViletTM and Vilet II QuickTM sutures are intended for single use. What is the shelf life for ViletTM and Vilet II QuickTM sutures? Both ViletTM and Vilet II QuickTM sutures have a maximum shelf life of 3 years (from date product is packaged).

18

* Registered trademarks of Ethicon Inc. ** Times are based on subcustaneous tissue implantation studies in rats.


TERMS AND CONDITIONS

Third-Party Links In anattempt to provide increased value to our visitors, Implant Direct Europe AG may link to sites operated by third parties. However, even if the third party is affiliated with Implant Direct Europe AG, Implant Direct Europe AG has no control over these linked sites, all of which have separate privacy and data collection practices, independent of Implant Direct Europe AG. These linked sites are only for your convenience and therefore you access them at our own risk. Nonetheless, Implant Direct Europe AG seeks to protect the integrity of its web site and the links placed upon it and therefore requests any feedback on not only its own site, but for sites it links to as well (including if a specific link does not work). Severability, No Waiver, Assignement In case that any provisions hereof, or any part thereof, is held by a court or authority of competent jurisdiction to be illegal, invalid or otherwise unenforceable, such provision or part thereof shall be enforced to the extent possible consistent with the intention stated therein, or, if incapable of such enforcement, shall be deemed to be amended as appropriate to remove the illegal or invalid provision or part but otherwise to retain the provision and other provisions hereof to the maximum extent permissible. No failure or delay of Implant Direct Europe AG to insist upon or enforce strict performance of any provision of these terms and conditions shall be construed as a waiver of any provision or right. Neither the course of conduct between the parties nor trade practice shall act to modify any of these terms and conditions. Implant Direct Europe AG may assign its rights and duties under these terms and conditions to any party at any time without notice to you. Applicable Law Your use of this site, and of the materials and products on this site, shall be governed in all respects by and construed in accordance with the laws of Switzerland, at the exclusion of the Swiss Federal Act on Private International Law and the U.N. Convention on Contracts for the International Sale of Goods. Any cause of action or claim you may have with respect to this site, including but not limited to the purchase of Implant Direct Europe AG products, must be commenced within one (1) year after delivery to the purchaser of the product or after the cause of action or claim arises, and subject to the condition that the purchaser examines at once the product upon receipt and immediately notifies Implant Direct Europe AG in the event he assumes the existence of any defect for which warranty or liability of Implant Direct Europe AG is not excluded. Jurisdiction You agree that jurisdiction over and venue in any administrative or legal proceedings directly or indirectly arising out of or relating to this site including but not limited to the purchase of Implant Direct Europe AG products, shall be in the ordinary courts of Zurich, Switzerland, to which jurisdiction and venue you unconditionally submit.

Limitation / Exclusion of Liability Implant Direct, LLC. or Implant Direct Europe AG shall not be liable to the fullest extent permissible pursuant to applicable law for any direct, special, incidental or consequential damages that result from the use of, or the inability to use, the material on this site or the performance of, or the inability to perform, the products, even if Implant Direct Europe AG has been advised of the possibility of such damages. Applicable mandatory law may not allow the limitation or exclusion of liability or incidental or consequential damages, so the above limitation or exclusion may not or not fully apply to you. Typographical Errors In the event that an Implant Direct Europe AG product is mistakenly listed at an incorrect price, Implant Direct Europe AG reserves the right to refuse or cancel any orders placed for product listed at the incorrect price. Implant Direct Europe AG reserves the right to refuse or cancel any such orders whether or not the order has been confirmed and your credit card charged. If your credit card has already been charged for the purchase and your order is cancelled, Implant Direct Europe AG shall issue a credit to your credit card account in the amount of the cancelled order. Term; Termination These terms and conditions are applicable to you upon your accessing the site and/or completing the registration and/or the ordering/shopping process. These terms and conditions, or any part of them, may be terminated or modified by Implant Direct Europe AG without notice at any time, for any reason whatsoever. With regards to orders already placed at the time of termination or modification these terms and conditions remain in force unaltered. The provisions relating to Copyrights, Trademark, Disclaimer, Limitation of Liability, Indemnification, Severability/No Waiver, Applicable law and Jurisdiction, shall survive any termination. Notice Implant Direct Europe AG may deliver notice to you by means of e-mail, a general notice on the site, or other reliable method to the address you have provided to Implant Direct Europe AG. Use of Site Harassment in any manner or form on the site, including via e-mail, chat, or by use of obscene or abusive language, is strictly forbidden. Impersonation of others, including an Implant Direct Europe AG or other licensed employee, host, or representative, as well as other members or visitors on the site is prohibited. You may not upload to, distribute, or otherwise publish through the site any content which is libellous, defamatory, obscene, threatening, invasive of privacy or publicity rights, abusive, illegal, or otherwise objectionable which may constitute or encourage a criminal or civil offence, violate the rights of any party or which may otherwise give rise to liability or violate any law. You may not upload commercial content on the site or use the site to solicit others to join or become members of any other commercial online service or other organisation. Participation Disclaimer Implant Direct Europe AG does not and cannot review all communications and materials posted to or created by users accessing the site, and is not in any manner responsible for the content of these communications and materials. You acknowledge that by providing you with the ability to view and distribute user-generated content on the site, Implant Direct Europe AG is merely acting as a passive conduit for such distribution and is not undertaking any obligation of liability relating to any contents or activities on the site. However, Implant Direct Europe AG reserves the right to block or remove at any time without notice communications or materials that it determines to be (a) abusive, defamatory, or obscene (b) fraudulent, deceptive, or misleading, (c) in violation of copyright, trademark or; other intellectual property right of another or (d) offensive or otherwise unacceptable to Implant Direct Europe AG, in its sole discretion. Indemnification You agree and undertake to indemnify, defend, and hold harmless Implant Direct Europe AG, its officers, directors, employees, agents, licensors and suppliers (collectively the “Service Providers”) from and against all losses, expenses, damages and costs, including reasonable attorneys’ fees, resulting from any violation of these terms and conditions or any activity related to your account (including negligent or wrongful conduct) by you or any other person accessing the site using your Internet account.

ORDERING PROCESS (Additional Terms & Conditions) Placing Orders In case of an order received by Implant Direct Europe AG after 14:30 (2:30p.m.) MET on Mondays through Thursdays, products will be dispatched the following working day, in case of an order received in such way on Fridays products will be dispatched the following Monday. Unless expressely agreed upon otherwise between Implant Direct Europe AG and the purchaser, the options as regards the date of dispatch (next day, two days, three days) include working days only and shall not include Saturdays (or Sundays and Holidays); in case you require special dispatch conditions (such as regarding specific date of surgery, specific date of dispatch) please insert your comment into the field “comments to order” hereinafter. With regard to particular Implant Direct Europe AG products a reduced VAT rate may apply in some countries. In such case Implant Direct Europe AG shall for the time being issue and provide you with amended invoices by e-mail. Benefit and Risk The benefit and risk with regard to the object of the purchase, i.e. the Implant Direct Europe AG product ordered by use of this site, passes to you upon placing of your respective order. Return and Replacement Policy You may return products to Implant Direct Europe AG within sixty (60) days from the date of delivery. In case of return Implant Direct Europe AG shall issue a credit note in your favour, however less a general stocking fee in the flat amount of Euro 50.00 per product returned. Any returning of products against cash is excluded. Demonstrably defective products or packaging shall be replaced upon your immediate notice by Implant Direct Europe AG within due course; any further rights and claims under applicable law, including but not limited to rescission or reduction of purchase prices are expressly excluded. Implant Direct Europe AG shall not be liable for or warrant any replacement of products in case of loss of implant or accidentally opened implants; you be herewith informed that loss of implant significantly results from such factors as surgical malpractice, unfavourable occlusion impact or lack of personal hygiene. Payment Modalities For orders which are not paid by credit card, the modalities of payment are defined on the final invoice to be sent out with an order. Implant Direct Europe AG reserves the right to change these modalities at any time for future orders. Contractual Currency You accept that the contractual currency shall be CHF, EURO, or GBP.

PLEASE READ THE FOLLOWING TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS WEBSITE www.implantdirect.eu. All users of this site agree that access to and use of this site are subject to the following terms and conditions and other applicable law. If you do not agree to these terms and conditions, please do not use this site. IN GENERAL Copyright The entire content included in this site, including but not limited to text, graphics or code is copyrighted as a collective work under the Swiss and other copyright laws, and is the property of Implant Direct Europe AG and/or of its affiliates or subsidiaries. The collective work may include works that are licensed to Implant Direct Europe AG and/or its affiliates or subsidiaries. ALL RIGHTS RESERVED. Permission is granted to electronically copy and print hard copy portions of this site for the sole purpose of placing an order Implant Direct Europe AG or purchasing Implant Direct Europe AG products. You may display and, subject to any expressely started restrictions or limitations relating to specific material, download or print portions of the material from the different areas of the site solely for your own non-commercial use, or to place an order with Implant Direct Europe AG or to purchase Implant Direct Europe AG products. Any other use, including but not limited to the reproduction, distribution, display or transmission of the content of this site is strictly prohibited, unless authorized by Implant Direct Europe AG or Implant Direct, LLC.. You further agree not to change or delete any proprietary notices from materials downloaded from the site. Trademarks All trademarks, service marks, and trade names of Implant Direct Europe AG, and/or of its affiliates or subsidiaries, used in the site are trademarks or registered trade marks of Implant Direct Europe AG, and/or of its affiliates or subsidiaries, until otherwise specifically noted. Warranty Disclaimer This site and the materials and products on this site are provided “as is” and without warranties of any kind, whether express or implied. To the fullest extent permissible pursuant to applicable law, Implant Direct Europe AG disclaims all warranties, express or implied, including, but not limited to, implied warranties of merchantability and fitness or a particular purpose and non-infringement. Implant Direct Europe AG does not represent or warrant that the functions contained in the site will be uninterrupted or error-free, that the defects will be corrected, or that this site or the server that makes the site available are free of viruses or other harmful components. Implant Direct Europe AG does not make any warranties or representations regarding the use of the materials in this site in terms of their correctness, accuracy, adequacy, usefulness, timeliness reliability or otherwise. Some States do not permit by mandatory law limitations or exclusions on warrantees, so the above limitations may not or not fully apply to you.

INFORMATION ABOUT GOODS TO BE RETURNED In case of goods to be returned from the EU countries, the following information must be appropriated on the package. Material Return to manufacturer Relocation process according to authorisation dated 1st November 2007 With authorisation no. 1041 MwSt,: DE256625533 Tax no.: 0941211523 Code

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Tollfree Infoline 00800 4030 4030 www.implantdirect.eu Address: Implant Direct Europe AG, Hardturmstrasse 161, CH-8005 Zürich Logistic Center: Implant Direct Europe AG, Basicweg 20, 3821BR Amersfoort, Netherlands

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Implant Direct Europe AG Hardturmstrasse 161 CH-8005 Zürich Tollfree Infoline 00800 4030 4030 www.implantdirect.eu

CAT-BIOMATERIALS-EN, printed 02-2017

Biomaterials Catalog - EU (English)  

Feattures complete line of biomaterials offered by Implant Direct including BIORESORB®, REGUARDE®, VILET™ & VILET II Quick™.

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