MitraCath transcatheter valve replacement system is a system that enables the placement of a stent mounted bioprosthetic heart valve in the mitral position. This technology is based on a nesting coaxial stent system enables the placement of any existing aortic or pulmonary valves in the non-circular shaped mitral (D-shape) orifice. The dual stent MitraCath system has an outer stent to provide anchoring in the non-circular shaped annulus, and the inner stent to mount the circular valve.
- Simple stent system to enable use of circular valves made for aortic and pulmonary replacement for the non-circular mitral and tricuspid positions.
- Stent design that enables one-shot implantation, eliminates peri-valvular leaks and ensures excellent anchoring to the native valve.
- Collapsible design that can be inserted into a catheter for transcatheter applications or can be surgically implanted for sutureless valve replacement.
Mitral Regurgitation (MR) is a large clinical problem, with high prevalence among adult Americans. 6 million Americans have severe MR requiring immediate clinical attention to avoid congestive heart failure, and 14 million more suffer from moderate to mild MR which ultimately requires correction at some point in the patient’s life. Of these patients, a significant number of patients with severe MR qualify as non-surgical candidates due to old age, poor cardiac function, or renal disease. In addition, data from the NIH funded CTSNET clinical trial indicate that early mitral valve repair/replacement can benefit patients with moderate MR. The number of patients with MR in Western Europe and Japan are estimated at 14 million and 2.5 million respectively.
The MitraCath system for percutaneous placement of a bioprosthetic valve in the diseased mitral valve is a novel technology that eliminates mitral regurgitation without the need for risky open heart surgery. This technology is based on the use of a novel nesting design between two opposing self-expanding stents. The outer stent is used for anchoring the device to the native mitral annulus and creating a circular lumen, and the inner stent is used to house the bioprosthetic heart valve. Using the dual stent system, this technology separates the impact of variability in a patient’s valve/annular geometry from the bioprosthetic valve to be implanted. This technology is a significant advance for existing transcatheter heart valve technologies developed for the aortic valve because it enables their use in the mitral valve as well.
Prototype is under development.