West Receives FDA 510(k) Clearance for Vial2Bag Advanced® 13mm Admixture Device

Rhea-AI Summary

West Pharmaceutical Services, Inc. (NYSE: WST) has announced the FDA 510(k) clearance and launch of its Vial2Bag Advanced® 13mm admixture device, complementing its existing 20mm admixture device. The new device offers needle-free reconstitution and transfer of drugs using either a 13mm or 20mm vial and an IV bag, addressing the need for more drug preparation and delivery options at the point-of-care.

West expands administration systems portfolio with new smaller size needle-free admixture device for immediate use IV drug transfer designed to maximize the benefits of point-of-care nursing.

EXTON, Pa., Dec. 4, 2023 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration systems, today announced FDA 510(k) clearance and launch of its Vial2Bag Advanced® 13mm admixture device.

The addition of the Vial2Bag Advanced® 13mm admixture device complements West's existing Vial2Bag Advanced® 20mm admixture device, with the two products providing options for the reconstitution and transfer of a drug using either a 13mm or 20mm vial and an IV bag before administration to the patient. The device is needle-free and has both a dual channel design to provide dedicated fluid pathways into and out of the IV bag and a robust vial spike design for connection to the drug vial. 

"This year, West celebrates 100 years as an industry leader and scientific innovator in high-quality injectable solutions," said Cindy Reiss-Clark, Chief Commercial Officer at West. "The 13mm product is a key addition to our administration system portfolio, addressing the critical need for more drug preparation and delivery options at the point-of-care."

Vial2Bag Advanced® 13mm admixture device has been officially launched at Progressive Medical Inc's Booth #500 at the American Society of Health-System Pharmacists Midyear Clinical Meeting Dec. 3 through 7, in Anaheim, CA.

About Vial2Bag Advanced® 13mm Admixture Device and Important Product and Safety Information

The Vial2Bag Advanced® 13mm admixture device is indicated to serve as a connection between a 50, 100 or 250ml IV bag, vial with 13mm closure, and an external IV administration set. The integrated vial adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. The Vial2Bag Advanced® 13mm admixture device is indicated for adolescent and adult patients only. For more information visit page https://www.westpharma.com/products/vial-adapter-systems/vial2bag-advanced-admixture-adapter-drug-transfer-system.

The Vial2Bag Advanced® 13mm and 20mm admixture devices are 510(k) cleared by the United States Food and Drug Administration. Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Important product and safety information and warnings at: https://www.westpharma.com/products/vial-adapter-systems/vial2bag-advanced-admixture-adapter-drug-transfer-system. These products are for prescription use only. The Vial2Bag Advanced® 13mm and 20mm admixture devices are intended for U.S. healthcare professional use only.

About West 

West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With 10,000 team members across 50 sites worldwide, West helps support our customers by delivering approximately 47 billion components and devices each year.  

2023 marks West's 100-year milestone of innovation and the critical role it continues to play in healthcare and the patient experience. Headquartered in Exton, Pennsylvania, West in its fiscal year 2022 generated $2.89 billion in net sales. West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor's 500 index. For more information, visit www.westpharma.com.

© 2023 West Pharmaceutical Services, Inc. 

West and the diamond logo are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.

Vial2Bag Advanced, Vial2Bag Advanced logo, Blue Vial Adapter, and Orange Vial Adapter are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

View original content to download multimedia:https://www.prnewswire.com/news-releases/west-receives-fda-510k-clearance-for-vial2bag-advanced-13mm-admixture-device-302004991.html

SOURCE West Pharmaceutical Services, Inc.

FAQ

What is the new product launched by West Pharmaceutical Services, Inc.?

West Pharmaceutical Services, Inc. has launched the Vial2Bag Advanced® 13mm admixture device.

What are the features of the Vial2Bag Advanced® 13mm admixture device?

The device offers needle-free reconstitution and transfer of drugs using either a 13mm or 20mm vial and an IV bag, providing more drug preparation and delivery options at the point-of-care.

Where was the Vial2Bag Advanced® 13mm admixture device officially launched?

The device was officially launched at Progressive Medical Inc's Booth #500 at the American Society of Health-System Pharmacists Midyear Clinical Meeting in Anaheim, CA.