“The burgeoning emergence of transcatheter aortic valve implantation (TAVI) has created a critical need for a non-surgical, large-hole (>12 Fr) access-and-closure device”
Earlier this year CardioLogical Solutions was formed from the merger of Emboline and VasoStitch. Now the emerging cardiovascular device company has announced that it has successfully completed in vivo validation of its TAVI access-and-closure device, VasoStitch™.
CardioLogical Solutions 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. The goal is to replicate current gold standard approaches while reducing the time and complexity of this part of the procedure. In so doing, the theory goes that healthcare costs could be reduced dramatically and patient management improved.
The VasoStitch solution, 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 patient will have reduced time to ambulation and shorter hospital stay.
The system does not yet have CE mark approval, which CardioLogical Solutions is aiming for subject to raising Series B financing.
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.
“The burgeoning emergence of transcatheter aortic valve implantation (TAVI) has created a critical need for a non-surgical, large-hole (>12 Fr) 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. ”
Source: CardioLogical Solutions, Inc., Business Wire