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| Vital Access' VWING Vascular Needle Guide--Courtesy of Vital Access |
Vital Access has secured a $10 million credit facility from Deerfield Management to expand marketing of its FDA-cleared implant to make it easier to access the vascular system of end-stage renal disease (ESRD) patients for hemodialysis. The cash is also intended to invest in additional vascular access products that might stem from the company's platform.
Arteriovenous fistulas (AVF) are the vascular access points that are typically used to conduct hemodialysis on ESRD patients. More than half a million Americans have kidney failure, or ESRD, according to the company. The Vital Access device, VWING Vascular Needle Guide, is an implant that's designed to facilitate access to the sometimes difficult to locate AVF.
"In many patients, palpating and cannulating the arteriovenous fistula is challenging; the use of VWING is demonstrated to improve cannulation success with fewer attempts, thereby improving the experience for patients and healthcare professionals and providing a safe alternative for establishing cannulatable fistulas," said Deerfield Partner Avi Kometz in a statement.
The FDA cleared the device from the Salt Lake City, UT-based company in 2013. In the SAVE study, a prospective, U.S. pivotal clinical trial, VWING was shown to provide reliable fistula access in 96% of patients who had been determined to have uncannulatable fistulas. Long-term, its use in the study was associated with significantly lower incidence of access site and systemic infection than published rates.
Essentially, once implanted beneath the skin, the titanium VWING device acts as a subcutaneous needle guide that allows for repeatable and reliable access to the AVF for hemodialysis. Typically, patients rely upon the skill of the healthcare provider to access the vasculature for hemodialysis. The device could also help to facilitate home hemodialysis and enable individuals to conduct the process entirely themselves.
"We will work to establish VWING as the gold standard for easier and more durable AV Fistula access for dialysis," said Vital Access President and CEO Doug Smith in a statement.
- here is the release