FDA Inks De Novo Approval for VasoPrep Surgical’s Surgical Marker Pen

VasoPrep Surgical tells us that the U.S. FDA has cleared its surgical marking pen under the agency’s de novo pathway, making it the first internal tissue marker cleared for use in the U.S. market.for sale in the U.S. market.

Background

The Dye Marker™, a Class II internal tissue marker indicated for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery, is used to demarcate selected sites and orientation of the vein graft prior to implantation.

Physician comments

Dr. Alan Dardik, Professor of Surgery at Yale School of Medicine and Chief of Vascular Surgery at VA Connecticut Healthcare Systems in West Haven, CT, said, “Recent data have shown that commonly used surgical skin markers can injure the vein graft. VasoPrep’s vein marker and vein preparation kit products are real advances that give surgeons new options to reduce injury to vein grafts for bypass surgery.”

Company comments

“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 U.S.,” said Cynthia Lander, Co-Founder and Chief Executive Officer of VasoPrep Surgical. “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.”

Source: PR Newswire

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