Galt Medical, a wholly-owned subsidiary of Theragenics, has received US Food and Drug Administration 510(k) clearance to market its Galt VTI valved tearaway introducer.
The Galt VTI tearaway introducer features an ergonomic, low-profile, patent-pending integrated valve which enables surgeons to place or provide access for other medical devices to enter into a patient's vascular system, reducing the risk of an air embolism and leakage.
Christine Jacobs, Theragenics chairman and chief executive officer, said the company expects the product to be a valuable addition to its current vascular access product platform, offering new features without affecting quality.
"The Galt VTI product is the most significant internally developed product released by our Surgical Products segment to date," Jacobs added.
"We intend to continue to focus on the development of new products that can utilise 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."
Galt VTI is a less bulky and a more compact design than currently available products, the company said. Galt Medical plans to launch the introducer in the second half of 2012 and expects to generate annualised revenue of $1m to $2m, with higher gross profit margins in the company's Surgical Products segment within one year of launch.
Theragenics surgical products business manufactures and distributes wound closure, specialty needle products and vascular access, including introducers and guidewires used in interventional radiology, interventional cardiology and vascular surgery.
Image: The VTI valved introducer from Galt Medical has gained US FDA clearance. Photo: FDA.