Rush University Medical Center, Chicago, IL First Prepackaged 26 mm Transcatheter Aortic Valve Premounted in a 14 Fr Delivery system: Miniswine implant in the Pulmonary Position of the Colibri Heart Valve Ziyad M. Hijazi MD MPH, R. David Fish MD, David Paniagua MD, Carlos Mejia BA, Eduardo Induni MD, David E. Paniagua BS, Elizabeth Gonzalez BA and Damien Kenny, MB MRCPCH Rush University Medical Center, Chicago, IL St. Luke’s Episcopal Hospital / Texas Heart Institute, Houston, TX, Hospital México, Universidad de Costa Rica, San José Costa Rica, Michael E. DeBakey VA Medical Center, ColibriHeart Valve LLC, Houston, TX

I have no relevant disclosures to report Damien Kenny, MB, MRCPCH I have no relevant disclosures to report

Background: Current THV Transcatheter heart valves (THV) are in rapid development, but currently have important deficiencies that complicate implantation and increase both technical and clinical risk. Implanted bioprosthetic heart valves are stored, transported, and delivered for use in a jar of solution. Before implantation, they must be rinsed and are prepared for use in a "wet" state that imposes higher packing volume and delivery profile. THV must be mounted and crimped upon the delivery catheter by the operators in the cath lab, which can be a source of delay, error and inconsistency. Available THV require large diameter delivery catheters of 18 Fr or larger, which may complicate transfemoral delivery and cause vascular injury and bleeding.

PARTNER Cohort B: TAVI Complications TAVI resulted in more frequent complications at 30 days ENDPOINT TAVI % Standard % P Major vascular complications 16.2 1.1 0.0001 Major bleeding episodes 16.8 3.9 Major strokes 5.0 0.06

Cause of Complications & Mortality? Stroke => 66.7 % Mortality 22 and 24 Fr Sizes Cause of Complications & Mortality?

Colibri Heart Valve A new THV that addresses these shortcomings has been developed with core features: Low profile Folded, thin pericardium membrane Dry valve, pre-mounted at manufacture Fully integrated, pre-packaged delivery system Storage and transport in dry state Ready to use directly from package into the patient Aortic and Pulmonary valve models Though dry at insertion, the membrane leaflets function immediately on deployment in the body.

Colibri Heart Valve – Low Profile Dry, Integrated, Pre-Packaged, Ready-to-use, Low-profile Colibri Heart Valve – Low Profile Special porcine pericardium tissue processing permits a dry membrane configuration that reduces THV profile: 22 – 26 mm : 14 Fr 27 – 30 mm : 16 Fr Dry, Integrated, Pre-Packaged, Ready-to-use, Low-profile

Thin-membrane, high tensile strength valve (>30 Mpa) : 3 x industry standard Very low mass and packing volume ➠ Low profile Aortic or pulmonary valve models: Balloon-expandable frame THV Premounted in delivery system in a DRY state DRY valve does not require rinsing, rehydration, or mounting in cath lab ➠ inserted directly from package into the body

Key to Low Profile and Dry Membrane: High Tensile Strength Ultimate Tensile Strength Tissue Strength Superior to Industry Standard Key to Low Profile and Dry Membrane: High Tensile Strength 50 MPa Minimum 30 MPa 12 MPa Aortic valve native operating load =13 KPa Wet Tissue Stress-Strain Samples

Operation in Pulse Duplicator

6 month sterility & accelerated aging confirmed Very low mass and packing volume ➠ Successful implants of DRY, 1 - month AGED, PRE-PACKAGED valves in dogs: Confirmed immediate hemodynamic competence in orthotopic implants in dogs: 5 Pulmonary + 3 Aortic Confirmed 1 - month chronic performance: 4 Pulmonary First – in – Man clinical pilot study scheduled for 2011 ICE: Dry PulmV 1 mo

ICE: Chronic Pulm - THV Long Axis from RVOT THV stored DRY for 1 month Dog Pulm Valve Implant 1 Month Chronic Explant

Mini-swine THV Implant in Pulmonary Position Dr. ZiyadHijazi Rush University Medical Center Mini-swine THV Implant in Pulmonary Position 22-26 mm TAVI valve 14 Fr Introducer

Mini-swine THV Implant in Pulmonary Position Dr. ZiyadHijazi Rush University Medical Center

22-26 mm TAVI valve Pulmonary Implant at 24 mm 14 Fr Introducer

Conclusions - 1 The folded, thin-membrane design of the Colibri valve achieves a very low-profile valve without a sacrifice in tensile strength, static loading or leakage. In vitro testing shows that low leaflet mass achieves low opening gradients and high coaptation efficiency at maximum acceleration. The Colibri dry-membrane valve functions immediately on deployment in both aortic and pulmonary positions in dog and sheep models. Chronic function of pre-mounted, pre-packaged dry THV implants is confirmed at 1 month in the dog model in the pulmonary position.

Conclusions - 2 Transcatheter implantation of the Colibri dry-membrane THV that is pre-mounted and pre-packaged in an integrated 14 Fr (22-26 mm THV) delivery system is feasible. A mini-swine pulmonary implant series is initiated in preparation for a first-in-human trial. The Colibri valve and integrated delivery system may increase the success and efficiency of THV procedures by easing femoral access and reducing procedural time, complexityand complications.

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