Description:
Direct to Phase II proposals will be accepted
Fast-Track proposals will be accepted.
Number of anticipated awards: 2
Budget (total costs): Phase I: $400,000 for up to 12 months; Phase II: $3,000,000 for 36 months
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Primary and secondary tricuspid valve regurgitation can cause disabling right heart failure, hepatic dysfunction, cardiorenal syndrome, and death. Primary surgical repair or replacement is highly morbid especially at the advanced stage of typical clinical presentation. Transcatheter repair using marketed and investigational clip-type devices is poorly suited for the trileaflet tricuspid valve. There is substantial unmet need.
This solicitation aims to support the development of an Transcatheter trileaflet tricuspid suture repair system for commercial clinical application.
Project Goals
The goal of this project is to develop a catheter system to achieve a non-surgical off-pump tricuspid valve LEAFLET repair that allows 3 or more sutures to reappose 3 or more tricuspid valve leaflets to repair secondary or primary tricuspid valve regurgitation, sometimes described as “clover-leaf repair.”
This project should generate an Early Feasibility Study (EFS) IDE for clinical evaluation in the United States, towards commercialization through a mechanism such as Phase IIb bridge-to-commercialization.
Phase I Activities and Expected Deliverables
A phase I award would develop and test working prototypes in swine. The contracting intramural laboratory wishes to test the final prototypes in vivo, and offers one earlier no-cost testing round to the contractor if desired.
The offeror should provide a complete transcatheter solution to effect suture apposition repair of three or more tricuspid leaflets. Elements of a complete system would typically include
• Low profile transvenous access
• Multi-axial deflectable guiding sheaths
• Leaflet traversal tools such as radiofrequency or mechanical energy transmission
• Retrieval tools to use in tandem with traversal tools
• Radiopaque tension elements such as sutures
• Force-redistribution elements that are radiopaque, such as pledgets, to prevent tension-induced leaflet injury
• Features to accomplish real-time image guidance including visibility under ultrasound and visibility under X-ray fluoroscopy
• Biocompatibility required of permanent endovascular clinical implants
• Capabilities to accomplish three or more points of apposition
Proposals that include novel image guidance and catheter navigation assistance in 3-dimensional space are welcomed.
A phase I award would develop and test functioning prototype system, including accessories, in vivo. At the conclusion of the Phase I award, the contractor should provide a detailed report of pre-IDE interactions with the Food and Drug Administration to identify clear requirements for human testing, including the summary of mutual understanding.
The contracting NHLBI DIR lab is willing to provide feedback about design at all stages of development. The contracting NHLBI DIR lab will test the final deliverable device for success in vivo in swine.
Phase II Activities and Expected Deliverables
In addition to meeting all requirements for Phase I, a phase II award would support testing and regulatory development for the device to be used in human investigation in the United States, under Investigational Device Exemption or other mutually agreed pathway. All FDA communications regarding the device should be shared with NHLBI.
The contracting DIR lab offers to perform an IDE clinical trial at no cost to the awardee. A complete Early Feasibility Study IDE application short of device verification and validation testing would constitute the deliverable.
A plan for separate Bridge-to-Commercialization funding support is invited to complete the Early Feasibility IDE licensed clinical study.
Offers are encouraged to supply a detailed milestone plan.
The offeror should have a proven track record of safe and compliant early-phase clinical testing of structural heart cardiovascular implants in the United States.
