VASCU-GUARD 

Currently, each VASCU-GUARD Patch is chemically sterilized and packaged in a jar filled with sterile, non-pyrogenic water containing propylene oxide.⁵ With the implementation of the new packaging, the patch will now be terminally sterilized via gamma irradiation and come in a double-pouch system (where the contents of the outer pouch are sterile). The inner pouch maintains the bovine pericardium patch’s moisture while packaged, and it doesn’t contain any water or solution.³ 

Baxter understands that efficiency in the OR is critical. The new VASCU-GUARD packaging configuration was developed to improve the customer experience without impacting the safety and effectiveness of the vascular repair patch.³

The pouch packaging provides some transit and workflow benefits to customers, including:³

No spills – no potential for solution spills when opening the package

Environmentally friendly – no storage solution to dispose of

Familiarity – new pouch design is commonly found in other OR devices

Reduced potential of product freeze in transit

It refers to the way the product is sterilized during the manufacturing process. In the case of the new VASCU-GUARD packaging, the sterilization is achieved by exposure to gamma irradiation, which penetrates the pouch packaging, at the end of the manufacturing process.³ This sterilization type is very common among Baxter medical devices, as well as other companies in the industry.

The change includes:^3,5

– Packaging format – from jar to pouch

– Sterilization method – from chemically sterilized to terminally sterilized (a slight difference in patch color should be expected due to the difference in sterilization method)

– Product codes

– Product indication – inclusion of arteriovenous access revisions (which was previously removed in the IFU change implemented in March 2022)

No. There will be no changes to the patch’s safety and effectiveness.³ The patch will retain the same properties and claims, including:

– Easy to handle and suture, similar to autologous vein⁴

– Resists suture line bleeding⁴

– Supports reapproximation to suture⁶

Yes. The patch will still need to go through the rinse procedure as described in the IFU (for a minimum of 3 minutes in a sterile basin containing 500 ml of sterile physiologic saline).³

At launch, the product will have a shelf life of 12 months.⁷ Testing is ongoing to increase shelf life.

No. The price will mirror the jarred product’s price as of January 1, 2022.

VASCU-GUARD should be stored at controlled room temperature (20 - 25°C / 68 - 77°F). During transport the product may be exposed to temperatures up to 62°C (144°F) for up to 96 hours, or exposed to temperatures as low as -15°C (5°F) for up to 72 hours.³

There will be a transition period, but once an order for the new code has been placed, customers won’t be able to order the jarred VASCU-GUARD. The jarred VASCU-GUARD will eventually be phased out of the US market.

No, VASCU-GUARD is not eligible for replacement or exchange.

No, access will not be managed via allocation. Any account may order the product after they have been in-serviced by their Baxter Advanced Surgery Sales Representative.

Baxter’s Advanced Surgery Sales Representatives will be conducting in-services. Upon completion of an in-service, your Baxter Sales Representative will ensure your facility has access to order pouched VASCU-GUARD.

In the event you experience difficulty placing your initial order(s) online, you may contact Baxter Center for Service at 888-229-0001 (prompt 3) with any questions, ensure they are aware of the challenges, and you will not incur any manual order fees.

You may contact your local Baxter Advanced Surgery Sales Representative with product-related questions or the Baxter Center for Service at 888-229-0001 (prompt 3) with any questions regarding product orders.