The eSVS is designed to help keep vein grafts open in patients undergoing coronary artery bypass surgery, according to the company’s brochure.
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.
Minneapolis-based Kips Bay plans to launch the eMesh I study in order to demonstrate the initial safety and performance of the eSVS mesh in order to obtain FDA approval to run a pivotal study.
The company further noted that it was forming its response to the FDA’s rejection of its previous IDE application.
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.
"If the FDA approves the amended IDE Application, U.S. physicians will then be allowed to begin enrolling patients," according to the filing. "Kips Bay Medical has already contacted prominent U.S. heart centers that are taking steps to secure internal approvals of their institutional review boards and administration/finance departments to participate in the study."
"Despite the FDA response, we have received a significant level of interest and excitement about our eSVS Mesh by several leading U.S. cardiac surgeons who we recently introduced the product to in anticipation of a potential study here in the U.S." Kips Bay founder Manny Villafaña said in prepared remarks. "Their high level of interest in and eagerness to study the eSVS Mesh is a tremendous motivator for me, and the Kips Bay team, to ensure that the clinical study of the eSVS Mesh is performed properly in both the U.S. and Europe."