MINNEAPOLIS, Minnesota — Bypass surgery device-maker Kips Bay Medical is raising $5 million to begin studies in the United States, according to a filing with the Securities and Exchange Commission.
Kips Bay is developing a device — eSVS Mesh — to support the veins used in bypass surgery. The mesh strengthens these veins, which are typically taken from the legs and not used to the pressure of working in the heart. There are fewer bypass surgeries now with the advent of stents, but bypass remains — for the moment — the standard for severe cases, such as three-vessel or left main coronary artery disease.
The company is the latest venture by Manny Villafana, who founded St. Jude Medical as well as a series of other heart device and biotech companies since the 1970s. Villafana said the company recently completed a 90-patient global study it will use to apply for Europe’s CE mark.
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It will use the next $5 million for working capital and to fund U.S. studies to apply for the U.S. Food and Drug Administration’s Investigational Device Exemption.