FDA Clearance For Galt VTI™ Valved Tearaway Introducer

In short

Theragenics Corporation®, a medical device company serving the surgical products and prostate cancer treatment markets, today announced that its subsidiary Galt Medical has received U.S. FDA 510(k) clearance to market its Galt VTI™ valved tearaway introducer.

Background

Introducers are used for vascular access, with the Galt VTI expected to be utilised primarily for placing catheters. It’s design allows surgeons the ability to introduce or provide access for other medical devices to enter into a patient’s vascular system while reducing the risk of an air embolism and leakage.

The Galt VTI is described as a tearaway introducer which includes an ergonomic, low-profile, patent-pending integrated valve. According to a company news release the Galt VTI is a less bulky and a more compact design than similar products currently available.

Company comments

“Both current and potential new customers have expressed significant interest in the Galt VTI product,” said M. Christine Jacobs, Chairman and Chief Executive Officer of Theragenics Corporation. “We expect this product to be a valuable addition to our current vascular access product platform, offering important new features along with the same high quality to which our customers are accustomed.”

Ms. Jacobs added, “The Galt VTI product is the most significant internally developed product released by our Surgical Products segment to date. 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. This is an important contributor to our growth, increased profitability and increased cash flow in our Surgical Products segment.”

Source: Theragenics Corporation, Business Wire