Kips Bay Medical (NSDQ:KIPS) won conditional FDA investigational device exemption approval for its eSVS mesh, allowing the company to begin a clinical study of the device in use during coronary artery bypass procedures.
The eSVS mesh provides support to keep vein grafts open during CABG procedures, and the FDA’s blessing grants Kips Bay approval to include 4 U.S. study sites in its ongoing eMESH I clinical feasibility trial.
The eMESH studies began in Switzerland in August 2012 in hopes of reversing a previous FDA rejection of an eSVS IDE application.
The device is comprised of a flexible, knitted sleeve that fits around the outside of the vein in order to reduce vessel wall stress and mitigate the potential for vessel injury.
In September 2011 the FDA issued Kips Bay a non-approvable letter, asking for more information on the eSVS mesh before granting IDE approval for perform pivotal human trials.
That decision sent KIPS shares plummeting 34% to an new all-time low in a single day.
The FDA had rejected Kips request for permission to add 4 U.S. sites to its ongoing feasibility trials. The federal watchdog agency asked for more information on pre-clinical testing design testing for the mesh, which Kips plans to provide within 30 days of filing its amended IDE application, according to an SEC filing.
The new approval provides a staged U.S. enrollment into the eMESH trials, starting with 5 patients. Kips Bay will provide 6-month data on those 1st 5 patients as well as 10 additional patients enrolled outside the U.S. before gaining approval to enroll the remaining 35 U.S. patients the company has asked for.
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