CardioLogical Solutions reports successful completed in vivo validation of its transcatheter aortic valve implantation (TAVI) access-and-closure device (VasoStitch).
“The burgeoning emergence of TAVI has created a critical need for a non-surgical, large-hole (>12F) access-and-closure device,” said David W J Smith, CardioLogical Solutions’ CEO. “With in vivo validation behind us, our next step is to produce finished devices in preparation for our first-in-human clinical study.”
CardioLogical Solutions states it is developing VasoStitch as both a transfemoral and transapical percutaneous access and repair device to facilitate the placement of the larger diameter percutaneous therapeutic devices. VasoStitch, consisting of disposable systems, is designed to enable 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. The company said in a press release, there could be reduced time to ambulation and shorter hospital stay for the patient.
CardioLogical Solutions is currently in the advanced stages of raising a series B financing to achieve CE mark for its initial Emboline and VasoStitch products. Initial commercial sales are estimated to begin in the ninth calendar quarter following the close of funding, beginning with the European launch of the first VasoStitch product and followed by the European launch of the first Emboline device approximately six months later.