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Bioabsorbable Stents for Neonatal Aortic Coarctation

Aortic coarctation is a common congenital heart condition that is usually recognized during the neonatal period early after birth. The usual treatment is open surgery. Non-surgical catheter-based stent therapy is not available to treat neonatal aortic coarctation because children outgrow commercially available metallic stents. Absorbable stents might revolutionize the treatment of aortic coarctation in children, especially in neonates.  Neonates require small delivery systems for relatively large nominal diameter implants, which is technically challenging.  No commercial alternatives are available for off-label medical use.  There is a considerable unmet need for a purpose-built, absorbable scaffold stent for neonatal aortic coarctation.
 
Project Goals
The Phase I award is intended to support the development of a mature prototype with the requisite geometry, strength, deliverability, and absorption characteristics required for the clinical product.
 
The Phase II award is intended to result in an Investigational Device Exemption (IDE) for a first human clinical test in the United States. 
 
Phase I Activities and Expected Deliverables
Expected deliverables are transcatheter stents 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 stents include:
?       small delivery systems (5 French or smaller);
?       sufficient radial force to resist elastic recoil for the coarctation;
?       sustained radial strength suited to the application for at least 6 months;
?       controlled degradation within 6-12 months;
?       inflammatory response that does not cause significant stenosis, restenosis, or aneurysm;
?       resistance to downstream embolization or toxicity;
?       geometry that does not threaten patency of the subclavian artery;
?       nominal calibers suitable for aortic coarctation.
 
Proposed stent nominal geometry should be diameter 6-10mm, length range 10-25mm, delivery system 5-6 French or smaller. The radial hoop strength of the deployed device should approach that of commercial balloon-expandable stent such as the Cordis Palmaz Genesis. Percutaneous vascular access routes for aortic coarctation application include transvenous-transeptal antegrade and retrograde transfemoral artery.  The implant and the delivery system should be conspicuous under the intended image-guidance modality to allow precise positioning.  Offerings should specifically provide the high radial force required to overcome immediate recoil of the target tissue, and should allow ?direct stent? treatment technique for native and iatrogenic lesions.
 
Phase I should focus on mechanical and biological performance of the proposed biodegradable stents in the intended use for aortic coarctation, taking into account mechanical strength required for the application; geometry of the access vessels and geometry and morphology of target vessels; strategies to avoid inflammatory restenosis or constriction; 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 testing and development requirements 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.
 
The sponsoring NHLBI laboratory is willing to perform a limited number of in vivo proof-of-principal experiments in swine (by mutual agreement). 
 
At the conclusion of Phase II, the offeror should obtain an IDE for a US-based first-in-human research protocol, involving at least 10 subjects.
 
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. 
 
 
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.

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