LOS ALTOS, Calif.--(EON: Enhanced Online News)--CardioLogical Solutions, an emerging cardiovascular device company, announced today that it has successfully completed in vivo validation of its TAVI access-and-closure device, VasoStitch™, which is the initial product in the Company’s pipeline.
“With in vivo validation behind us, our next step is to produce finished devices in preparation for our First-in-Human clinical study.”
The VasoStitch platform technology is derived from intellectual property invented by serial entrepreneur Amir Belson, M.D., founder of NeoGuide Systems, Vascular Pathways, Zipline Medical, Thermocure, and Radguard Medical.
“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. ”
Current surgical arterial or cardiac access-and-closure for large diameter catheter-based intervention adds about an hour to an already long, complex procedure. A device designed to replicate the current “gold standard” of surgical access and closure in a more rapid and facile fashion could reduce healthcare costs dramatically, enhance adoption of large diameter cardiovascular and endovascular therapies and, finally, improve the efficiency of patient management. 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 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.
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.
About CardioLogical Solutions
Privately held CardioLogical Solutions is an emerging medical technology company focused on developing novel accessory device platforms for interventional cardiology procedures, such as transcatheter aortic valve implantation (TAVI). CardioLogical Solutions was formed by the merger of two independent device companies, VasoStitch, which is developing nonsurgical transfemoral and transapical access-and-closure systems to facilitate deployment of large diameter (>12 Fr) transcatheter therapeutic devices; and Emboline, which is developing aortic embolic protection devices for prevention of stroke and other ischemic complications during interventional procedures. The current combined potential for these markets is estimated at over $3 billion and is expected to grow significantly with the continued adoption of TAVI and other cardiovascular and endovascular procedures. CardioLogical Solutions is based on the technologies of serial inventor and entrepreneur Amir Belson, M.D.
NOTICE: CardioLogical Solutions’ products are not available for sale in the United States.