Unmet Clinical Need

• A low profile, transcatheter aortic valve which mimics natural valve system

Device Description

• Transcatheter balloon expandable aortic valve system designed to mimic natural aortic valve.
• Crafted out of single pericardium similar to Japanese ‘Origami’.
• Self skirting with tissue instead of Dacron used in earlier generation valves.
• Allows for minimum number of stitched segments thereby eliminating stresses from the system.
• Acute study in a porcine model was performed at the Skirball Center for Cardiovascular Research, NY. One valve was deployed in each of two pigs harboring aortic insufficiency. The animals were maintained under anesthesia to evaluate valve performance.
• The objectives of the study were to :
• Assess the ease of valve deployment
• Evaluate acute hemodynamic performance
• Study bio-functionality of the valves
• Observations & Conclusions:
• Acute valve performance in 2 pigs demonstrates-
• Successful deployment of the valve
• Good crimping and radial force of expansion
• Good valve retention and
• Valve functionality
• The above observations matches bench results
• The second larger animal study is now being planned with reduced profile of the device to study chronic performance.