FoldaValve™ is a next generation Transcatheter Aortic Heart Valve Replacement (TAVR) system. It is fully repositionable and retrievable at 14-Fr delivery size and is expandable to 25mm. Due to its unique folding mechanism, FoldaValve™ has the smallest delivery size at true 14-Fr. FoldaValve™ employs a fundamentally different concept for celivery, by sparing its leaflets from severe crimping within the stent and thus preserving the quality of the leaflets. FoldaValve™ is uniquely equipped with an IVUS-guided, intravascular ultrasound delivery system (Ingenuity™) that not only improves delivery and implantation procedures by providing additional imaging views of the valve and patient’s vascular anatomy, but also can reduce exposure to x-ray due to Fluoroscopy during implantation to both physician and patient. Ingenuity™ allows repositioning in six degrees-of-freedom and allows retrieval if the implantation procedure is unsuccessful.
Smaller delivery profile
Repositionability and ability to retrieve
FoldaValve’s ultrasound-guided system, Ingenuity™, not only has the smallest delivery profile but also it provides six-degree of positioning/repositioning and allows the interventionalist to retrieve the valve during the procedure, as needed. Together, these features would allow more patients to have access to this life-saving cardiac intervention and provide an additional level of safety to TAVR procedures.