A local medical technology company, Kips Bay Medical, announced Wednesday that it has received approval from the U.S. Food and Drug Administration to enroll additional patients into its eMESH I clinical feasibility trial.
Kips Bay Medical, headquartered in Minneapolis, was founded by Chairman and CEO Manny Villafana. He also founded CPI/Guidant and St. Jude Medical. Villafana started Kips Bay Medical in 2007.
The feasibility trial is a multi-center study of Kips Bay Medical’s eSVS Mesh in coronary artery bypass graft surgery. The mesh is used to support blood vessels that are taken from another part of the body and used to bypass the blocked coronary artery. The mesh surrounds the vein like a sleeve, and is designed to improve the structural characteristics and long-term performance of the graft.
The FDA initially approved a staged enrollment in the United States, starting with five patients at up to four sites. The FDA now has increased the number of patients from five to 15.
As part of the trial, Kips Bay Medical will provide six-month follow up angiograms on the first 10 patients enrolled in trials in Europe and the U.S. combined. The FDA will review those angiograms and, if it finds them acceptable, Kips Bay Medical said it expects to be allowed to enroll the remaining U.S. patients in the trial here.
All told, the company said it expects to enroll up to 120 patients at eight European and four U.S. sites. Data from the feasibility study will be used as the basis for a pivotal trial in the U.S. to attempt to gain FDA approval.