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Transcatheter Cavopulmonary Bypass Endograft

Extra-anatomic bypass or vascular shunts divert blood flow.  In congenital heart disease, these surgical procedures are critical for management.  Children born with one functional ventricle or cardiac pumping chamber require two to three major cardiac surgery procedures for palliation.  The management goal is to divert systemic venous return (deoxygenated blood) from the heart directly to pulmonary artery circulation such that the single ventricle can pump oxygenated blood returning to the heart from the lungs to the body.  These multiple surgical procedures carry significant morbidity and mortality, as well as incur substantial hospital costs secondary to lengthy hospital stays.  A minimally invasive transcatheter approach would revolutionize the management of these children with congenital heart disease.  No commercial alternatives exist for off-label medical use.  Children born with ?single ventricle physiology? represent 7.7% of congenital heart disease diagnosed in childhood and have a birth incidence of approximately 4?8 per 10,000.  In the United States, this represents approximately 2,000 children born each year.  The commercial market is small enough to discourage the early development costs of a transcatheter cavopulmonary bypass endograft.  There is a considerable unmet need for a purpose-built cavopulmonary anastomosis device.
 
Project Goals
The goals of this project are to develop and test a transcatheter cavopulmonary bypass endograft prototype in vivo in Phase I, and to develop a clinical device and obtain an FDA Investigational Device Exemption (IDE) for first-in-human testing in the United States in Phase II.
 
Phase I Activities and Expected Deliverables
Expected deliverables are transcatheter endografts to be delivered using conventional interventional cardiovascular techniques including guiding catheters or sheaths, trans-lesional guidewires, and balloon-expandable or self-expanding delivery systems. Conventional and novel approaches are welcomed.
 
Specific requirements of the endografts include:
?       Delivery systems (10-12 French or smaller);
?       Sufficient radial force to resist elastic recoil (with specific focus at anastomosis site);
?       Nominal calibers suitable for the most common lesions;
?       Freedom from ?pull-through? of the anastomosis once deployed; and
?       Accommodation for growing children (ultimately dilatable to adult size vessels).
 
Proposed endograft nominal geometry should be diameter 10-14mm, length range 25-50mm, and delivery system 10-12 French or smaller. The radial hoop strength of the deployed device should approach that of commercial endovascular stent grafts such as Gore Viabahn or Atrium iCast. Percutaneous vascular access routes would be trans-venous.  The implant and the delivery system should be conspicuous under the intended image-guidance modality; MRI compatibility is considered important.  Offerings should specifically provide the high radial force required to overcome immediate recoil of the intended applications, and should allow ?direct stent? treatment technique.
 
Considerable detail should be supplied about the intended mechanical and biological performance of the graft-pulmonary anastomosis, including resistance to inadvertent separation and pull-through, hemorrhage, thrombosis, neointimal overgrowth, angulation, distortion or failure by patient and cardiovascular motion, and anticipated flow characteristics.
 
Phase I should focus on mechanical and biological performance of the proposed endograft, taking into account the mechanical strength required for the application; geometry of the access vessels and geometry and morphology of target vessels; ?growth? accommodation to achieve larger size and delivery, implantation, and visualization strategies.
 
At the conclusion of Phase I, a candidate device design should be selected for clinical development based on in vivo performance of a mature prototype resembling a final design. Consideration for transition to Phase II funding will include progress toward regulatory clearance. Consideration may include the status of the contractor?s interactions with the Food and Drug Administration (FDA); therefore, contractors are encouraged to provide a detailed report of pre-IDE interactions with the FDA identifying requirements for IDE development under Phase II, including the summary of mutual understanding, if available. NHLBI encourages contractors to consider requesting designation to the FDA?s Expedited Access for PMA Devices (EAP) program (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf) during the Phase I award period. 
The sponsoring NHLBI laboratory is willing to perform a limited number in vivo proof-of-principal experiments in swine (by mutual agreement) to confirm mechanical performance.
 
Phase II Activities and Expected Deliverables
The activities in Phase II should align with the required testing and development milestones agreed upon with the FDA in Phase I. The device should fit the specifications as described in the Phase I Activities and Expected Deliverables. The offeror should provide clear project milestones.
 
At the conclusion of Phase II, the offeror should submit an IDE for a US-based first-in-human research protocol, involving at least 10 subjects.
 
If the IDE is not granted during Phase II, the offeror must provide an FDA response that indicates that the specific deficiencies are limited to Current Good Manufacturing Design Verification and Validation, and that the offeror-proposed plan to address these deficiencies would be considered acceptable.
 
Offerors are encouraged to consider the NHLBI Phase IIB Small Market Award program (https://www.nhlbi.nih.gov/research/funding/sbir/small-market-awards.htm) to support additional development beyond Phase II. The NHLBI Phase IIB Small Market Awards provide up to an additional $3M over 3 years, with an expectation that applicants secure independent third-party investor funds.
 
The sponsoring NHLBI laboratory is willing to perform a limited number of in vivo proof-of-principal experiments in swine (by mutual agreement). 
 
 
NHLBI offers, but does not require, to perform the clinical trial at no expense to the offeror, to participate in the development of the clinical protocol, and to provide clinical research services.   The vendor is expected to perform or obtain safety-related in vivo experiments and data to support the IDE application.  

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