09.18.13
Vital Access Corp. received U.S. Food and Drug Administration (FDA) clearance for its patented VWING vascular needle guide, which enables vascular access to arteriovenous fistulas (AVF) for patients undergoing hemodialysis. The VWING already was available in Europe and Canada.
Kidney failure affects millions of people worldwide, and hemodialysis (cleaning the blood by removing it from the body and passing it through a dialyzer, or artificial kidney) through an autologous AVF is the gold standard for patients undergoing treatment. The type of access a person has is important for getting the best dialysis possible. There are three types of access: catheter, arteriovenous (AV) graft and arteriovenous (AV) fistula. A fistula used for hemodialysis is a direct connection of an artery to a vein. Once the fistula is created it is a natural part of the body. This is the preferred type of access because once the fistula properly matures and gets bigger and stronger; it provides an access with good blood flow that can last for decades. After the fistula is surgically created, it can take weeks to months before the fistula matures and is ready to be used for hemodialysis.
However, establishing and maintaining reliable vascular access continues to be a significant challenge, and is made worse by the growing prevalence of obesity, diabetes and hypertension among kidney failure patients.
The VWING is a surgically placed vascular needle guide that is completely subcutaneous and extravascular. It provides an "easily palpable target" for needle insertion and guides a dialysis needle directly to the targeted vessel, enabling the use of blunt needles via a guided constant site or "buttonhole" cannulation, according to the company.
The buttonhole cannulation technique has been shown in multiple clinical studies to reduce AV fistulae complications and improve long-term fistula durability and patency. However, the technique has not gained broad adoption due to practical challenges with clinical implementation. The VWING is designed to enable the use of buttonhole cannulation technique.
The VWING is supported by clinical evidence collected in the recently completed SAVE study. The study was a multi-center, AV fistula salvage trial that included 54 dialysis patients with uncannulatable, deep AV fistulae, who were implanted with VWINGs (82 devices were implanted in total) and followed for six months post-implantation.
"The SAVE study demonstrated that the VWING vascular needle guide is an effective and safe tool for uncannulatable AVFs, with an impressive salvage rate of 96 percent," said Duane Blatter, M.D., founder and chief medical officer of Vital Access Corp. "The study also demonstrated high buttonhole cannulation success and low occurrence of device related adverse events, including infection and stenosis. I believe the VWING will enable clinicians to better address the access needs of hemodialysis patients by facilitating effective AVF cannulation in a wide range of dialysis patients."
Tip Jennings, M.D., vascular surgeon and principal investigator in the SAVE study, said: "I expect the device will be an important option for vascular access surgeons. Non-usable fistulas were easily converted to a reliable vascular access quickly, using the VWING implanted in a relatively minor procedure. Patients and staff were very pleased with the outcomes."
"We believe VWING will be the tool of choice for vascular surgeons to overcome anatomical limitations and provide consistent access for dialysis patients." said Doug Smith, president and CEO of Vital Access. "Moreover, it will give nephrologists and dialysis centers the ability to prescribe the most optimal cannulation method for each patient, regardless of clinic staffing or patients' anatomical limitations."
Vital Access is a privately held company located in Salt Lake City, Utah, that designs and manufactures surgical and interventional technologies for vascular access.
Kidney failure affects millions of people worldwide, and hemodialysis (cleaning the blood by removing it from the body and passing it through a dialyzer, or artificial kidney) through an autologous AVF is the gold standard for patients undergoing treatment. The type of access a person has is important for getting the best dialysis possible. There are three types of access: catheter, arteriovenous (AV) graft and arteriovenous (AV) fistula. A fistula used for hemodialysis is a direct connection of an artery to a vein. Once the fistula is created it is a natural part of the body. This is the preferred type of access because once the fistula properly matures and gets bigger and stronger; it provides an access with good blood flow that can last for decades. After the fistula is surgically created, it can take weeks to months before the fistula matures and is ready to be used for hemodialysis.
However, establishing and maintaining reliable vascular access continues to be a significant challenge, and is made worse by the growing prevalence of obesity, diabetes and hypertension among kidney failure patients.
The VWING is a surgically placed vascular needle guide that is completely subcutaneous and extravascular. It provides an "easily palpable target" for needle insertion and guides a dialysis needle directly to the targeted vessel, enabling the use of blunt needles via a guided constant site or "buttonhole" cannulation, according to the company.
The buttonhole cannulation technique has been shown in multiple clinical studies to reduce AV fistulae complications and improve long-term fistula durability and patency. However, the technique has not gained broad adoption due to practical challenges with clinical implementation. The VWING is designed to enable the use of buttonhole cannulation technique.
The VWING is supported by clinical evidence collected in the recently completed SAVE study. The study was a multi-center, AV fistula salvage trial that included 54 dialysis patients with uncannulatable, deep AV fistulae, who were implanted with VWINGs (82 devices were implanted in total) and followed for six months post-implantation.
"The SAVE study demonstrated that the VWING vascular needle guide is an effective and safe tool for uncannulatable AVFs, with an impressive salvage rate of 96 percent," said Duane Blatter, M.D., founder and chief medical officer of Vital Access Corp. "The study also demonstrated high buttonhole cannulation success and low occurrence of device related adverse events, including infection and stenosis. I believe the VWING will enable clinicians to better address the access needs of hemodialysis patients by facilitating effective AVF cannulation in a wide range of dialysis patients."
Tip Jennings, M.D., vascular surgeon and principal investigator in the SAVE study, said: "I expect the device will be an important option for vascular access surgeons. Non-usable fistulas were easily converted to a reliable vascular access quickly, using the VWING implanted in a relatively minor procedure. Patients and staff were very pleased with the outcomes."
"We believe VWING will be the tool of choice for vascular surgeons to overcome anatomical limitations and provide consistent access for dialysis patients." said Doug Smith, president and CEO of Vital Access. "Moreover, it will give nephrologists and dialysis centers the ability to prescribe the most optimal cannulation method for each patient, regardless of clinic staffing or patients' anatomical limitations."
Vital Access is a privately held company located in Salt Lake City, Utah, that designs and manufactures surgical and interventional technologies for vascular access.