A meeting of the Circulatory System Devices Panel was held on June 22, 2005. The Panel discussed, made recommendations, and voted on a premarket approval application (P040049) for the Acorn CorCap Cardiac Support Device (CSD).
The CorCap CSD is indicated for use in adult patients who have been diagnosed with dilated cardiomyopathy and are symptomatic despite treatment with optimal heart failure medical management. Patients appropriate for this procedure have a dilated heart (LVEDD > = 60 mm or LVEDDI >= 30 mm/m2) and an LVEF = < 35% (LVEF <= 45% if planned mitral valve repair or replacement).
The sponsor presented data from a two-arm randomized study of 300 patients at 30 sites. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (9-4) for disapproval. The panel cited concerns regarding lack of clinical outcome data, missing effectiveness data and potential risk to patients.
A meeting of the Circulatory System Devices Panel was held on June 23, 2005. The Panel discussed and made recommendations on a humanitarian device exemption (HDE) (H040006) for the Abiomed, Inc. Abiocor Implantable Replacement Heart.
The Abiocor Implantable Replacement Heart 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.
A Humanitarian Use Device (HUD) is 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. A Humanitarian Device Exemption (HDE) is an application to market an HUD and is similar in both form and content to a premarket approval (PMA) application, but exempt from the effectiveness requirements of a PMA.
For an HDE to be approved FDA must be able to determine that:
- The device does not expose patients to unreasonable risk of illness or injury;
- The probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available treatments.
The sponsor presented data from 14 patients at 4 clinical sites. The panel struggled with a decision indicating the risk/benefit determination even for a very sick patient population with limited options was difficult due in part to the small amount of data, the high proportion of adverse events related to anticoagulation therapy and the lack of valid Quality of Life data. Three motions were brought to the floor and failed to result in a majority vote. The final vote of the panel was a motion to indicate that the data presented by the sponsor met the HDE criteria as stated above. The final vote, 7 against, 6 for and 1 abstention, indicated that the panel believed that the sponsor failed to meet HDE criteria. The voting outcome reflected the difficulty the panel members had in reaching a decision on this first of a kind device.
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.