The US Food Drug Administration (FDA) has granted 510(k) approval to Galt Medical's Galt VTI valved tearaway introducer.
The Galt VTI features a low-profile, patent-pending integrated valve which facilitates surgeons to introduce or provide access for other medical devices to enter into a patient’s vascular system reducing the risk of an air embolism and leakage.
Theragenics chairman and chief executive officer Christine Jacobs said the company expects this product to be a valuable addition to its current vascular access product platform, providing important new features along with the same quality to which customers are accustomed.
"We intend to continue to focus on the development of new products that can utilize the FDA 510(k) clearance process in all our business units," Jacobs added.
"This is an important contributor to our growth, increased profitability and increased cash flow in our Surgical Products segment."