June 23, 2005Abiomed, H0400060 DRAFT. CIRCULATORY SUPPORT DEVICES PANEL Thursday, June 23, 2005 Abiomed, Inc. Abiocor® Implantable Replacement Heart HDE.

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Presentation transcript:

June 23, 2005Abiomed, H DRAFT

CIRCULATORY SUPPORT DEVICES PANEL Thursday, June 23, 2005 Abiomed, Inc. Abiocor® Implantable Replacement Heart HDE H DRAFT

June 23, 2005Abiomed, H FDA Review Summary Abiomed, Inc. Abiocor® Implantable Replacement Heart Eric Chen M.S. FDA/CDRH/ODE/DCD

June 23, 2005Abiomed, H Overview of Presentation What is an HDE? History of Feasibility Study Pre-clinical Evaluation Clinical Evaluation Panel Questions

June 23, 2005Abiomed, H FDA Review Team M. Berman, Ph.D. E. Chen, M.S. V. Covington D. Fleischer K. Foy, M.S. E. Harvey, Ph.D. D. Headlee M. Mendelson I. Piña, M.D. J. Rinaldi, M.S. W. Scott, Ph.D. J. Swain, M.D.

June 23, 2005Abiomed, H What is an Humanitarian Device Exemption? An HDE application is similar in both form and content to a premarket approval (PMA) application, but exempt from the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD). (Humanitarian Device Exemption Regulation: Questions and Answers Final Guidance for Industry

June 23, 2005Abiomed, H What is an Humanitarian Use Device? A device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year. (Federal Food, Drug, and Cosmetic Act,

June 23, 2005Abiomed, H AbioCor Implantable Components

June 23, 2005Abiomed, H

June 23, 2005Abiomed, H Proposed Indication for Use The AbioCor is indicated for use in severe end stage heart disease patients who: are less than 75 years old, are not transplant candidates at the time of assessment, require multiple inotropic support, are in biventricular failure not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support and not awaiting transplantation.

June 23, 2005Abiomed, H U.S. Feasibility Study IDE G –Single arm prospective feasibility trial to determine safety of the AbioCor –Sample size of 14 patients –6 investigational sites –No prospective statistical plan or control group –Incremental gate for study continuation If none of first 5 patients survived 30 days - stoppage At least 1 out of 5 patients – survived 60 days –Slow enrollment

June 23, 2005Abiomed, H Candidate Selection Process Two stage process –Screening Determine severity of heart failure (AbioScore) Potential fit of the AbioCor (AbioFit) –Implant consent

June 23, 2005Abiomed, H HDE Regulation (21 CFR 814 Subpart H) REASONABLE assurance of safety and probable benefit Factors considered (21 CFR b) –Patient population –No other comparable device available (other than another HDE device or device approved under IDE) –Probable benefit vs. probable injury Clinical experience (21 CFR b)

June 23, 2005Abiomed, H Preclinical Evaluation Determined To Be Satisfactory Alarms Battery Performance Biocompatibility Electrical Safety and EMC Manufacturing Software Sterilization, packaging, shelf life, shipping

June 23, 2005Abiomed, H Preclinical Evaluation Concerns Remain Reliability –Internal components Membrane wearout Bearing failure –Device end of life indicator

June 23, 2005Abiomed, H Reliability Bench Testing 25 units on test Mock circulation loop –Implanted components in 37ºC buffered saline –Failure times between 8.2 to 40.5 months –Average runtime – 18.8 months –Reliability greater than 80% at 80% confidence level for one-year operation 3 failure modes –Hydraulic membrane wearout –Bearing failure –Fluid ingress

June 23, 2005Abiomed, H Clinical Failures Patient #2 –Membrane wearout at 17 months (expected) –Patient refused to have AbioCor replaced –Propose to tighten tolerance on energy converter –Continue to monitor membrane wearout Patient #13 –Bearing failure at 5 months (unexpected) –Position of AbioCor different than pre-placement CT scans –Corrective actions have been accepted by FDA

June 23, 2005Abiomed, H Engineering Summary Replacement requires major surgery Device end of life behavior seen during bench testing 2 device malfunctions –1 membrane wearout –1 bearing wearout

June 23, 2005Abiomed, H Summary Results of the pre-clinical testing in conjunction with the outcome of the reliability results from the clinical trial suggest that the device performs according to specifications.