SBIR-STTR Award

The objective of this contract is to design a series of prototype transcatheter devices that will enable a wide range of novel transcatheter procedures for both adult and pediatric structural heart patientsThere is an unmet need for a suite of tools that will enable a wide range of novel but attainable non surgical interventional cardiovascular procedureswhich the contractor will develop and testThese devices will deliver and secure sutures inside the beating heart without surgery and promise a dramatic impact on cardiovascular therapeuticsas conceived of by DrLedermanThe contractor will address the technical and innovation challenges that will be necessary for clinical implementation of DrLederman s discovery

Small Business Innovation Research (SBIR) Topic 103, Devices for Transcatheter Surgery, was advertised in Program Solicitation PHS 2018-1.Under Phase II the contractor will continue to develop and test a collection of independent catheter devices for transcatheter electrosurgery procedures to treat adult and pediatric structural and congenital heart diseases without surgery.These highly novel devices promise a dramatic impact on cardiovascular therapeutics.They will apply force to cardiac chambers to remodel failing right ventricles and severe tricuspid regurgitation.The Phase II work will include refinement and regulatory development of the devices and delivery of devices in a quantity sufficient to test in thirty human subjects.