VasoPrep Surgical’s Vein Preparation Kit is the company’s first offering in its multi-generational line of vascular products. It is a sterilized convenience kit for use during the preparation and irrigation of bypass grafts prior to use in bypass surgery. The kit was cleared for sale in the United States by the U.S. Food and Drug Administration in March 2014 under 510(k) pre-market notification K131659.
The kit contains the following components, designed specifically to maintain the health of a venous transplant:
- The only surgical marking pen available on the market in the U.S. today that is specifically indicated for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft. It has been cleared for sale in the U.S. by the U.S. Food and Drug Administration (under de novo petition DEN130004.)
- A pressure relief assembly that automatically limits distention pressure during preparation of the vein to a safe range.
- A bulldog clamp for atraumatic vein occlusion.
- A vein cannula and cannula introducer assembly to facilitate vein distention.
- Miscellaneous components (syringes, temporary vein storage cup) to further facilitate the vein preparation procedure.
The kit is single-use and comes sterilized in a sterile tray with a dual sterile barrier. The kit is available only for prescription use in the U.S.