Medical device company VasoPrep Surgical has obtained de novo approval from the US Food and Drug Administration for its surgical marking pen, Dye Marker.
The Class II internal tissue marker has been developed for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery.
It will be used to demarcate selected sites and orientation of the vein graft prior to implantation and is the first internal tissue marker cleared for use in the US market, noted VasoPrep.
VasoPrep Surgical co-founder and CEO Cynthia Lander said: "The FDA’s clearance of the Dye Marker represents a significant milestone for VasoPrep and completes our first product line available for sale in the US.
"We hope that our products become important components of standard surgical vein harvest and provide surgeons with new tools to reduce surgical harvest-associated vein graft injury and spare bypass patients the clinical consequences that may be associated with vein graft failure."
Earlier, the company also received 510(k) approval from FDA for its Vein Preparation Kit, a sterilized convenience kit for use during preparation and irrigation of bypass grafts prior to use in bypass surgery.
The company will commence sale of both products in the first quarter of 2015.