Theragenics Receives FDA Clearance for Galt VTI Valved Tearaway Introducer
May 1, 2012 — Theragenics Corp. announced that Galt Medical, a wholly-owned subsidiary of Theragenics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Galt VTI valved tearaway introducer. Introducers are utilized for vascular access, with the Galt VTI expected to be utilized primarily for placing catheters.
The Galt VTI is a tearaway introducer that includes an ergonomic low-profile patent-pending integrated valve. The Galt VTI allows surgeons the ability 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. The Galt VTI is a less bulky and a more compact design than similar products currently available.
The addressable market in the United States for the Galt VTI is estimated to be approximately $14 million of annual sales and growing at 5 percent annually. The Galt VTI is expected to launch in the second half of 2012, with revenue in the range of $300,000 expected based on indications of interest from Galt Medical’s customer base. Within 12 months of launch, the company expects the Galt VTI to generate annualized revenue of $1 million to $2 million, with gross profit margins higher than currently being realized in Galt Medical’s surgical products segment.
“Both current and potential new customers have expressed significant interest in the Galt VTI product,” said M. Christine Jacobs, chairwoman and CEO of Theragenics Corp. “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.
“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,” added Jacobs.
Galt Medical is a wholly-owned subsidiary of Theragenics. The Galt business unit manufactures and distributes vascular access products, including introducers and guidewires used in interventional radiology, interventional cardiology and vascular surgery. Theragenics operates two business segments: its surgical products business and its brachytherapy seed business.
For more information: www.theragenics.com