Arstasis Preclinical Study Demonstrates Safety of Novel Access Technique for Catheter-based Procedures
FREMONT, Calif. – Jan. 29, 2015 – Arstasis, Inc., a medical device company pioneering a vastly different approach to vascular access, today announced preclinical data comparing its AXERA® 2 Access System to the standard method known as the modified Seldinger technique. The study, “Vascular Healing After Arterial Access: A Histopathological Comparison of Standard Seldinger Versus a Novel Access Technology,” published in Endovascular Today, demonstrated no statistically significant difference in healing of the entry point created in the blood vessel used for minimally invasive and catheter-based procedures, either immediately after or 30 days post-procedure. Additionally, there were no complications using the AXERA System.
“The access technique devised by Dr. Seldinger is the gold standard for catheterization procedures, but despite its nearly 60-year history, few studies have examined its effects on healing,” said Renu Virmani, MD, president and medical director of CVPath Institute in Gaithersburg, Maryland. “These data provide evidence at the cellular level of equivalent healing between the Seldinger technique and the AXERA system. Furthermore, we saw no evidence of dissection, an uncommon but serious complication of catheterization procedures.”
The AXERA System provides a unique approach to vascular access by modifying the angle of approach used to create the hole in the femoral artery, the blood vessel used to introduce the instruments necessary for catheter-based procedures. In contrast to the nearly perpendicular puncture used with the Seldinger technique, the AXERA System creates a diagonal and shallow 10° to 15° angle. This results in a tissue-on-tissue overlap that promotes self-sealing via the patient’s natural blood pressure. To date, the AXERA System has been used in more than 60,000 procedures in the United States.
“Safer, more efficient and more comfortable procedures are needed, especially in light of the trend toward more complex catheter-based interventions and healthcare economic pressures,” said Bruce Modesitt, chief executive officer of Arstasis, Inc. “The AXERA System promotes natural healing simply by modifying the angle of approach to access, thereby eliminating the need for a foreign body closure device, which is of particular importance for patients with peripheral arterial disease.”
The AXERA System is a sterile, single use device intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The AXERA System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths. For more information, visit www.arstasis.com.