CardioLogical Solutions, a cardiovascular device company, has reported successful in vivo validation of its VasoStitch device, designed to make transcatheter aortic valve implantation (TAVI) procedures percutaneous and safer.
The VasoStitch device, which is based on technology derived from intellectual property invented by serial entrepreneur Dr Amir Belson, is being developed by the company as both a transfemoral and transapical percutaneous access and repair device to help placing the larger diameter percutaneous therapeutic devices.
The device includes disposable systems and will allow the physician to combine the traditional interventional access techniques with a standard suture-based surgical repair, thus reducing procedural complexity and eliminating the need for an open surgical procedure.
CardioLogical Solutions CEO David W. J. Smith noted the burgeoning emergence of TAVI has created a critical need for a non-surgical, large-hole (>12 Fr) access-and-closure device.
"With in vivo validation behind us, our next step is to produce finished devices in preparation for our First-in-Human clinical study," Smith added.
Currently, the company is in advanced stages of raising Series B financing to achieve CE Mark for its initial Emboline and VasoStitch products, and is expected to begin initial commercial sales in the ninth calendar quarter following the close of funding.
The company will initially begin the commercial sales of first VasoStitch product and followed by the first Emboline device approximately after six months in Europe.