Conductance Balloon Coronary Post-Dilatation Catheter
Stent malapposition leads to less optimal outcomes (restenosis and thrombosis) in coronary stenting. 3DT is developing a novel conductance balloon (CB) coronary post-dilatation catheter system (the CB catheter) that accurately measures and displays real-time balloon size. The device provides an innovative, clinically-relevant, real-time, simple, accurate, repeatable, and objective sizing measurement during coronary post-dilatation to aid in stent deployment and proper minimum stent area (MSA) / minimum stent diameter (MSD) determination.
Stabilization Device for Trans-septal Access
Transseptal (TS) procedures for accessing the left side of the heart are an important and rapidly growing space for diagnostics and therapy delivery. Currently, TS procedures are used in the following FDA-approved procedures: atrial fibrillation (AF) ablation, correction of atrial septal defects (ASD), degenerative mitral valve repair and left atrial appendage (LAA) closure. 3DT is developing a guiding catheter for device delivery into the left atrium for accurate and safe placement of steerable guides. Various design features will significantly reduce the propensity for inaccurate punctures and perforations.
Mild Hypothermia Catheter for Reperfusion Injury
ST segment elevation myocardial infarction (STEMI) is the most severe form of acute coronary syndrome (ACS) that affects nearly 500,000 Americans each year and places a heavy clinical and financial burden on the healthcare system. STEMI treatment requires prompt reperfusion to limit myocardial injury (recommended time of less than 90 minutes from hospital arrival to therapy delivery or 90-minute door to balloon time). Mild hypothermia (MH), i.e., temperature ~34°C, provides cardio-protection and decreased infarct size following MI by reducing myocardial metabolic demand, free radical creation, and platelet aggregation. 3DT is developing a novel, catheter-based method of selective auto-retroperfusion (SARP) to deliver hypothermia to the cardiac region of interest.
Aortic stenosis (AS) affects approximately 1.5 million Americans and places a large financial burden on the U.S. healthcare system. Percutaneous catheter delivery of a prosthetic aortic valve, called transcatheter aortic valve replacement (TAVR), has emerged as a treatment option for severe AS. Paravalvular leakage is seen in up to 67% of patients 1-3 years after TAVR implantation, which is in part due to size mismatch of the TAVR device versus the native aortic valve annulus. 3DT is developing a novel 2-in-1 sizing valvuloplasty conductance balloon (SVCB) catheter system that serves as a standard valvuloplasty balloon for aortic valve dilatation prior to implant (all TAVR procedures involve valvuloplasty) as well as a valuable tool that accurately measures and displays real-time aortic annulus size during inflation.
3DT owns a portfolio of over 200 issued and pending patents that cover inventions in the areas of electrical conductance-enabled therapeutic devices, retroperfusion-enabling devices, devices enabling pericardial access, smart clamps, magnetic occlusion and endograft/endoprosthesis devices, A-Fib/stroke prevention, valve removal / annulus remodeling, and bariatric devices.