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.
The National Institutes of Health has awarded ValVention Inc. $350,000 to study the effectiveness of FoldaValve™ transcatheter aortic valve replacement (TAVR) system. The NIH funding will support a project to test the hypothesis that the patented sheathed inverse folding mechanism of the FoldaValve™ technology is more durable and protective of the valve’s structural integrity when compared with standard crimping methods…
Transcatheter aortic valve replacement (TAVR) is an essential alternative to surgical aortic valve replacement (SAVR) in elderly patients with aortic valve stenosis. At the current pace, TAVR procedures are expected to increase twofold from ~163,000 in 2020 to ~289,000 in 2025, and the number of patients with severe aortic stenosis is anticipated to rise to 3.5M by 2050. ValVention Inc…