Chronic total occlusions (CTOs), defined as vessels that have been completely occluded for 3 months, are a prevalent vascular disease found in about one-third of patients undergoing a coronary angiogram and in 30-50% of peripheral procedures. Revascularization of CTOs offers important benefits to the patient including reduced angina symptoms, improved left ventricular function, reduced need for Coronary Artery Bypass Graft (CABG), and a lower incidence of death or Myocardial Infarction (MI), but success rates are still considerably low. Inability to cross a CTO with a guide wire is by far the leading cause of failed CTO revascularization attempts (89% of cases in some studies), thus medical device makers have focused on improving cross rates via two strategies: specialized CTO wires and dedicated CTO devices. However, these new devices have either resulted in increased risk of perforation and dissection of the vessel or have had marginal improvements in CTO penetration. Therefore, there is still an unmet need for an active CTO device that is safe, highly effective at tunneling through CTOs, and augments the use of a conventional guide wire - the workhorse device of intervention lists. Frantz Medical Development (FMD) has identified a solution to this unmet need: a miniaturized electromagnetic engine incorporated into the distal end of a vascular guide wire and catheter combination. The engine is constructed by fixing a series of spaced magnetic beads to a guide wire and outfitting the catheter with a corresponding set of coil segments. Driving the coils with alternating current produces an alternating magnetic field, which acts on the magnets to vibrate the guide wire. The vibrations at the guide wire tip provide additional penetrating force for active penetration through CTOs. Users can activate the vibrations anytime additional penetrating power is desired, and then switch off the system to return to a passive guide wire that retains the same feel and handling characteristics of a traditional wire. Based on encouraging feasibility results, FMD has prepared this proposal describing the goals and strategy of Phase I, Concept Development. By the completion of Phase I, FMD will have built 3rd Generation prototypes of the VTG System and used them for validating the safety, efficacy, and usability of the technology for crossing refractory CTOs. The 3rd Generation design will be scaled down to final size and will incorporate various other performance improvements. The final scale prototypes will then be used for fine tuning the operating parameters and for confirming the safety, efficacy, and usability of the device, both on the bench and in an in vivo animal study. In addition, FMD will have established a clear path through the next phases of development and commercialization. , ,
Public Health Relevance: Angioplasty, a minimally invasive catheterization procedure that opens a blocked coronary or peripheral vessel with a balloon and commonly a stent, has improved the outcome of patients with vascular disease. Our vibration guide wire platform technology will improve angioplasty of chronic blockages (""Chronic Total Occlusions"") while maintaining the safety of these procedures, ultimately increasing the number of patients with chronic occlusions that can be safely treated with angioplasty.
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