Cardica Inc.s PAS-Port coronary proximal anastomosis device 510(k) will be reviewed by FDAs Circulatory System Devices Panel April 22 in Gaithersburg, Md.
By FDA Advisory Committee, [RxPG] Cardica Inc.s PAS-Port coronary proximal anastomosis device 510(k) will be reviewed by FDAs Circulatory System Devices Panel April 22 in Gaithersburg, Md.
The PAS-Port system an alternative to sutures connects the proximal end of vein grafts to the aorta during coronary artery bypass graft (CABG) surgery. The device consists of an implantable connector and a delivery system to deploy the implant in the target vessel.
PAS-Port is CE-marked and distributed in Europe by Guidant, which has 20% stake in Cardica. More than 650,000 bypass surgeries are performed annually worldwide, according to the Redwood City, Calif. firm.
In March 2004, the Circulatory System Devices Panel convened to discuss clinical trial criteria for anastomosis devices, following concerns about underlying causes of adverse events associated with the products.
The panel recommended more stringent data requirements to support 510(k) submissions, including six-month angiographic follow-up for pivotal studies, an independent clinical events committee to address potential trial bias and 12-month post-market follow-up.
In addition to discussing the Cardica 510(k), panel members at the April 22 meeting will hear from the device centers Office of Surveillance & Biometrics regarding the review process for condition-of-approval (CoA) studies. The advisory committee also will be briefed on devices it previously evaluated.
The Center for Devices & Radiological Health is shifting responsibility for CoA studies from the Office of Device Evaluation to the Office of Surveillance & Biometrics to ensure study completion. The center has said that publishing a guidance explaining CoA study requirements is a 2005 priority.
