FDA Engineering Presentation1 Division of Cardiovascular Devices Panel Meeting Center for Devices & Radiological Health April 22, 2005 Kachi Enyinna, M.S.,

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Presentation transcript:

FDA Engineering Presentation1 Division of Cardiovascular Devices Panel Meeting Center for Devices & Radiological Health April 22, 2005 Kachi Enyinna, M.S., Scientific Reviewer, Circulatory Support and Prosthetics Devices Branch Kachi Enyinna, M.S., Scientific Reviewer, Circulatory Support and Prosthetics Devices Branch Barbara Krasnicka, Ph.D., Statistician, Office Surveillance & Biometrics Barbara Krasnicka, Ph.D., Statistician, Office Surveillance & Biometrics Wolf Sapirstein, MD, Medical Officer, Division of Cardiovascular Devices Wolf Sapirstein, MD, Medical Officer, Division of Cardiovascular Devices

FDA Engineering Presentation2 PAS-Port Proximal Anastomosis System by Cardica Inc.

FDA Engineering Presentation3 Indications for Use Cardica’s proposed indication for use: –The PAS-Port® System is intended to create an everting anastomosis (end-to- side) between the aorta and autologous vein graft. Predicate: St. Jude Medical Symmetry Aortic Clip

FDA Engineering Presentation4 PAS-Port® Proximal Anastomosis System PAS-Port System consists of: PAS-Port System consists of: –Delivery System – used to attach conduit. –Implant – stainless steel tubing used to connect veins (conduit) to vascular vessels in an end-to-side fashion.

FDA Engineering Presentation5 Comparison to Predicate The PAS-Port was designed to be similar to the St. Jude Symmetry. The PAS-Port was designed to be similar to the St. Jude Symmetry. Both systems deliver and implant a metallic star shape connector for hemostatic anastomosis between the aorta and saphenous vein during CABG surgery. Both systems deliver and implant a metallic star shape connector for hemostatic anastomosis between the aorta and saphenous vein during CABG surgery. No new technological characteristics differentiating the two systems. No new technological characteristics differentiating the two systems.

FDA Engineering Presentation6 PAS-Port vs Symmetry Absence of conduit Cannulation Absence of conduit Cannulation Full thickness aorta and conduit capture by the device Full thickness aorta and conduit capture by the device Single action for delivery and aortotomy Single action for delivery and aortotomy Reduced Profile Reduced Profile Reduced amount of metal in blood path: Reduced amount of metal in blood path: –PAS-Port = in 2 –Symmetry = in 2

FDA Engineering Presentation7 PAS-Port vs Symmetry The controversial features of the predicate do persist however, with the PAS-Port. The controversial features of the predicate do persist however, with the PAS-Port.

FDA Engineering Presentation8 PAS-Port vs Symmetry Exposure of metal to blood reduced but still present Exposure of metal to blood reduced but still present PAS-PortSymmetry

FDA Engineering Presentation9 PAS-Port vs Symmetry Non-compliant annular containment exist at orifice with stent like scaffolding is still conducive to kinking. Non-compliant annular containment exist at orifice with stent like scaffolding is still conducive to kinking. PAS-PortSymmetry Hand Sewn Suture

FDA Engineering Presentation10 History While there are cleared devices, FDA convened an Advisory Panel one year ago to clarify clearance requirements for anastomotic devices. While there are cleared devices, FDA convened an Advisory Panel one year ago to clarify clearance requirements for anastomotic devices. Since that time, the St. Jude Medical Symmetry device has been withdrawn from the market, Bypass Maakafim CorLink AAD has not been commercialized, and Coalescent U-Clip is marketed as a suture. Since that time, the St. Jude Medical Symmetry device has been withdrawn from the market, Bypass Maakafim CorLink AAD has not been commercialized, and Coalescent U-Clip is marketed as a suture.

FDA Engineering Presentation11 Performance Testing Summary A.Functional Testing Summary 1.Formation of Anastomosis 2.Leakage at Site of Anastomosis 3.Poke Through Test 4.Pull Through Test 5.Aortic Plug Capture 6.Implant Pull Out Test 7.Hard Stop

FDA Engineering Presentation12 Performance Testing Summary (cont’d) Pre-Fire Tests 8.Knob and Switch 9.Cartridge Lock 10.Safety Switch

FDA Engineering Presentation13 Performance Testing Summary (cont’d) B.Fatigue Testing of Implant –Finite Element Analysis –Physical Fatigue Testing –Corrosion Resistance C.Pre-Clinical (Animal) Testing D.Clinical Testing

FDA Engineering Presentation14 Device Modifications Study I The device implant used in Study I is technically different from the implant used in Cohort II study. The device implant used in Study I is technically different from the implant used in Cohort II study. In early submission, sponsor notes that “minor changes in the pre-shaped implant geometry and implant shaping procedures” were performed. In early submission, sponsor notes that “minor changes in the pre-shaped implant geometry and implant shaping procedures” were performed.

FDA Engineering Presentation15 Summary of Device Modifications Attachment 9 of original 510(k) outlines the several modifications on the PAS-Port implant. Attachment 9 of original 510(k) outlines the several modifications on the PAS-Port implant.