Puros Custom Block

Question 1

What is an allograft?

Answer 1

An allograft is a tissue from a donor human source.

Question 2

What is a xenograft?

Answer 2

A xenograft is a tissue for an animal source

Question 3

What is an autogenous source?

Answer 3

Autogenous means that the tissue source is from the same specimen. Meaning derived from the body of the patient receiving the tissue.

Question 4

What is an alloplast?

Answer 4

An alloplast is a synthetic material used to augment natural bone tissue.

Question 5

Which of the 4 bone types is Puros?

Answer 5

Puros is an allograft

Question 6

What are the 2 main ways that allografts are processes to ensure the safety of the recipient patient?

Answer 6

Tutoplast process and freeze drying processes

There are several specific processes within freeze drying that also differ from one another

Question 7

Which sterilization process does Puros use to ensure the safety of the recipient patient?

Answer 7

Tutoplast

Question 8

Does the Tutoplast process incorporate freeze drying the allograft at any point?

Answer 8

NO - Freeze drying is an effective way to ensure the allograft is safe to use, but it does damage the cellular structure of the material.

Question 9

If freeze drying damages the cellular structure of the material, why would it be used?

Answer 9

It is a cost effective and timely process so it is less expensive.

Question 10

Is freeze drying bad or outside the standard of care?

Answer 10

No - there are several freeze drying processes that are effective. Cancelle SP is an example of one that is effective and it is used with the Zimvie Regeneross CC allograft material.

However, Tutoplast has been shown in several studies to be more effective and consistent that any of the freeze drying processes.

Question 11

Describe the Tutoplast process

Answer 11

The Tutoplast process takes 39 days where the tissue goes through delipidization, and osmotic treatment followed by an oxidative treatment. It is then cleaned by solvent dehydration and low-dose gamma radiation.

The result preserves the valuable collagen matrix and tissue integrity while inactivating pathogens and gently removing unwanted materials such as cells, antigens and viruses. You are left with a safe, biocompatible material.

Question 12

How many patient procedures have been performed using Puros globally?

Answer 12

Over 5.5 million with zero incendence of infrection related to the Puros allograft.

Question 13

In what 3 ways is Puros allograft available?

Answer 13

Particulate
Preformed blocks
Custom blocks

Question 14

Does the Puros custom block utilize cancellous or cortical bone types?

Answer 14

The Puros custom bone block uses only cancellous bone.

Question 15

How long does it take to get a Puros custom bone block?

Answer 15

Puros custom bone blocks take 8 weeks to process. This starts from the approval of the block design by the clinician.

Question 16

The Puros custom bone block fits precisely to the defect. What is an advantage to having a precise fit?

Answer 16

Maximizing the contact surface area of the block to the defect, thus maximizing the ingrowth of blood cells and revascularization is the key benefit to a precise fit. Additional benefits are ease of use or clinical manageability and reduced surgery time due to minimal adjustments.

Question 17

How is a Puros custom block produced?

Answer 17

A custom block is produced using CAD/CAM technology based on a CBCT/CT scan of the defect area.

Question 18

Detail the Puros custom block workflow.

Answer 18

Scan with either a CT or CBCT machine. Save the resulting DICOM file

Upload the DICOM file to implantconcierge.com and create a new Puros custom bone block case. You may need to create an account if you do not already have one.

Design - Zimvie will design a custom bone block based upon the parameters give with the case upload. You will be notified when the design is ready for your review.

Review - log into the implantconciere.com portal to review he design. You can also download the design to review in the .stl viewer of your choice. Any necessary adjustments can be communicated and made to the design at this point.

Approve the design - Your approval is required before the block is release to be milled.

Milling

Shipping - The final block will be gamma radiation sterilized and shipped in double pouched sterile packaging. The block will be shipped in approximately 8 weeks.

Surgery

Question 19

What sizes are Puros customer blocks available in?

Answer 19

A standard Puros Block will be a maximum size of 27X15X15mm

A large Puros block will be a maximum size of 60X30X30mm

Question 20

Is primary closure over the Puros custom block required?

Answer 20

Yes - utilize a full thickness flap . Extend the full thickness incision beyond the graft site at least 1 tooth bilaterally. Use releasing incisions to adequate visualization and tension free closure.

Question 21

How long does a Puros custom block take to heal?

Answer 21

It is important to prevent premature loading by waiting until complete healing has occurred. This typically takes 5-6 months.

Question 22

Who is Zimvie’s primary competitor for custom bone block grafts?

Answer 22

There are none at this time. The Puros custom block is the only solution of this type.