/General product information

A summary of MRI safety information for devices labeled as MR conditional can be found at here. For a full version of conditions, please see product Instructions for Use.

Please find the information on our approved products at https://www.goremedical.com/products.

 

If you do not find the needed information, please contact your local Field Sales Associate or send a request to Customer Service.

Please find the Instructions for Use at https://eifu.goremedical.com/.

/Ordering, contracts, returns

Please send a request to Customer Service, or contact our Customer Service by phone.

For product availability, pricing and ordering in your country, contact your local Gore Medical Products office or one of the authorized third party distributors or agents.

If you have any questions about the suitability and approved indications of products, please contact your local Field Sales Associate or send a request to Customer Service.

Orders may be placed during normal business hours Monday - Friday by sending a request to Customer Service.

Gore collaborates with e-commerce providers for e-ordering. GHX (Global Healthcare Exchange) is our preferred e-commerce provider. Please send a request to Customer Service for more information.

All product returns require a return authorization number which can be obtained by sending a request to Customer Service. 

 

Products must be in their original packaging, unopened and in saleable condition.

Standard payment terms are net 30 days. Invoices reflect the price at the time of order fulfillment.

/Shipping information

U.S. orders are shipped second day delivery at no additional expense.

 

Canadian orders are shipped for next day delivery at no additional expense. Shipments are subject to conditions beyond the control of Gore, such as weather, strikes and transport capacity.

Expedited shipping may be available upon request and may incur additional charges.

All products are provided sterile unless otherwise noted. In the case of non-sterile products, please send a request to Customer Service. 

 

If you have any questions, please contact your local office.

Gore's worldwide organizational structure, coupled with an integrated product distribution network, ensures that Gore medical products are approved and available in many countries.

 

Highly trained Gore representatives are in most regions around the world. Gore also utilizes Authorized Partners for distribution, sales and technical case support in many international markets.

 

These third parties have met Gore's qualifications to sell, distribute and support Gore medical products.

/Product specific information

Can a patient with an implanted device made from PTFE and polyglycolic acid/trimethylene carbonate (PGA/TMC) copolymer safely undergo radiation and/or chemotherapy?

 

Yes. The amount of radiation needed to degrade PTFE is substantially above the patient survival dose. There have been no specific studies conducted to assess the impact of radiotherapy or chemotherapy on our PGA/TMC material. There is clinical evidence, however, of acceptable outcomes of patients receiving postoperative chemotherapy following implantation of GORE® BIO-A® Tissue Reinforcement. Additionally, GORE® BIO-A® Tissue Reinforcement is gamma irradiated during sterilization at doses that are typically much higher (i.e., up to 500x) than therapeutic radiation doses.

 

 

How will a device made from PTFE and PGA/TMC show up on CT, MRI, or X-rays?

 

Because of the density differences between PTFE and the rest of the body, high resolution imaging techniques, such as CT and MRI, will reveal PTFE, both immediately following implant and after ingrowth at longer time frames. X-rays offer a fairly low resolution level and will not show a PTFE product. Because of the inherent chemical and density differences between the PGA/TMC polymer and the rest of the body, adequately high resolution imaging techniques, such as CT and MRI, should reveal the presence of the implant. The material will not be damaged nor interfere with the MRI other than by being visible. However, the original signal will slowly fade as the implant degrades and is assimilated into the tissue.

 

 

Has there ever been an allergic reaction to a Gore product made from PTFE and PGA/TMC material?

 

No. Since PTFE is one of the most inert and biocompatible polymers available, there has never been a confirmed allergic reaction to a Gore PTFE product. There have been no allergic cases reported to Gore on our PGA/TMC material and it is not expected to elicit an allergic response.

Can you cross-clamp the graft?

 

As with all ePTFE grafts, care should be taken to avoid mechanical damage to or disruption of the graft. Use the appropriate atraumatic or guarded (for example, rubber shod) clamps. Avoid repeated, localized clamping or excessive clamping on any section of the graft.

 

 

Can you incorporate the densified ePTFE support sections (the 'rings') in an anastomosis of the GORE® INTERING® Vascular Graft?

 

Yes, the densified ePTFE supports are designed such that suture can be passed through them. These densified ePTFE sections at the anastomosis can assist in maximizing the anastomotic opening.

 

 

Does the GORE® INTERING® Vascular Graft radial support compromise ingrowth and tissue attachment?

 

We have data showing that tissue ingrowth still occurs through the radial support. In contrast, no ingrowth occurs through the full density PTFE or FEP material used for rings or spiral support on other grafts.

 

 

Have you ever had a confirmed allergic reaction to ePTFE?

 

We have never had a confirmed allergic response to ePTFE. PTFE is the most inert substance known and is very biocompatible.

 

 

Is there a profile on the lumen due to the radial support of the GORE® INTERING® Vascular Graft?

 

No, it is smooth.

 

 

Is there any latex in the GORE-TEX® Vascular Graft?

 

No.

 

 

What is the compression resistance of the GORE® INTERING® Vascular Graft?

 

The compression resistance of the Thin-Walled GORE® INTERING® Vascular Graft is approximately 400-450% that of a 6 mm Thin-Walled GORE-TEX® ePTFE Graft. However, it is approximately 53% that of a SRRT graft of the same configuration.

 

 

Why do certain surgeons report a better patency rate with the GORE-TEX® Stretch Vascular Graft?

 

Though we did not create the Stretch graft with improving patency in mind, some surgeons have reported greatly improved patency rates. We do not have an explanation for this occurrence. Dr. Tordoir of the Netherlands reports in his publication that perhaps the reason for less thrombosis and stenosis with the Stretch graft is the "lengthwise compliance of the prosthesis that may offer a better matching of the mechanical properties between the graft and native vessels.

 

 

Will there be increased suture hole bleeding from the integrated rings of the GORE® INTERING® Vascular Graft?

 

Our experience shows no difference.

Have you ever had a confirmed allergic reaction to ePTFE?

 

We have never had a confirmed allergic response to ePTFE. PTFE is the most inert substance known and is very biocompatible.

 

 

Is there any latex in the GORE-TEX® Vascular Graft?

 

No.

 

 

Why do certain surgeons report a better patency rate with the GORE-TEX® Stretch Vascular Graft?

 

Though we did not create the Stretch graft with improving patency in mind, some surgeons have reported greatly improved patency rates. We do not have an explanation for this occurrence. Dr. Tordoir of the Netherlands reports in his publication that perhaps the reason for less thrombosis and stenosis with the Stretch graft is the "lengthwise compliance of the prosthesis that may offer a better matching of the mechanical properties between the graft and native vessels.

Have you ever had a confirmed allergic reaction to ePTFE?

 

We have never had a confirmed allergic response to ePTFE. PTFE is the most inert substance known and is very biocompatible.

 

 

Is there any latex in the GORE-TEX® Vascular Graft?

 

No.

 

 

What size suture should be used to decrease suture hole bleeding?

 

The CV-6 GORE-TEX® Suture on a TTc-9 needle offers a 1:1 needle-to- suture ratio which surgeons have said minimizes bleeding.

 

 

Why do certain surgeons report a better patency rate with the GORE-TEX® Stretch Vascular Graft?

 

Though we did not create the Stretch graft with improving patency in mind, some surgeons have reported greatly improved patency rates. We do not have an explanation for this occurrence. Dr. Tordoir of the Netherlands reports in his publication that perhaps the reason for less thrombosis and stenosis with the Stretch graft is the "lengthwise compliance of the prosthesis that may offer a better matching of the mechanical properties between the graft and native vessels.

Have you ever had a confirmed allergic reaction to ePTFE?

 

We have never had a confirmed allergic response to ePTFE. PTFE is the most inert substance known and is very biocompatible.

 

 

Is there any latex in the GORE-TEX® Vascular Graft?

 

No.

 

 

Why do certain surgeons report a better patency rate with the GORE-TEX® Stretch Vascular Graft?

 

Though we did not create the Stretch graft with improving patency in mind, some surgeons have reported greatly improved patency rates. We do not have an explanation for this occurrence. Dr. Tordoir of the Netherlands reports in his publication that perhaps the reason for less thrombosis and stenosis with the Stretch graft is the "lengthwise compliance of the prosthesis that may offer a better matching of the mechanical properties between the graft and native vessels.