Kips Bay Medical Weighs Options
Kips Bay Medical’s clinical trial on its sole product, the eSVS mesh for use in coronary artery bypass grafting surgery, has not proven successful. In a Thursday press release, the devicemaker said it could be forced to shut down if it is unable to secure additional financing.
The company underwent significant reorganization in January, going from 13 to eight employees.
In March, the devicemaker was able to raise private equity under the condition that the mesh clinical trial reached a certain benchmark in preliminary results released in May. Of an initial 10 patients implanted with the device, seven displayed lower efficacy than those in the control arm at their six-month follow-up angiogram.
The FDA issued a non-approvable letter in September 2011 for the eSVS mesh, requesting more information on the device before allowing a feasibility study. In November 2012, that permission was given. — Jason Scott