Merit gains FDA approval for contrast system; nabs rights to two new products

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Disposable medical device maker Merit Medical Systems, while disclosing the acquisition of rights to two new products, said it has received clearance from the FDA for its Miser contrast management system, expected to available in the first quarter of 2009.

Merit has acquired the rights to a radial artery compression device used for maintaining a given pressure following a cardiac procedure. The product is set for launch in 2009 following further development and regulatory approvals, according to Fred Lampropoulos, Merit's chairman and CEO.

Additionally, the company has acquired rights to a device used for the removal of cuffed catheters and other products. This device, which already has 510(k) clearance from the FDA, can be sold as a stand-alone product or as part of a kit.

The South Jordan, Utah-based Merit also disclosed that it received ISO 13485 certification of its facility in Richmond, Va., which will enable the company to make products that may be sold in countries requiring the CE mark.