Intact Vascular Announces Completion of TOBA-BTK Trial Enrollment
WAYNE, PA – November 4, 2014 – Intact Vascular, a medical device company and developer of products for minimally invasive peripheral vascular procedures, today announced its completion of the TOBA-BTK Study, Tack Optimized Balloon Angioplasty – Below the Knee Study.
This multi-center pilot study focused on gathering data supporting the safety and performance of the Tack Endovascular System™ in subjects with Critical Limb Ischemia (CLI) due to vascular disease below the knee. Thirty-five subjects were enrolled in this study which targeted diseased tibial vessels for treatment.
Critical Limb Ischemia (CLI) is an advanced stage of peripheral artery disease in which patients suffer from inadequate blood flow to the lower leg and foot. If left untreated, this may lead to pain, gangrene and tissue loss (amputation). Balloon angioplasty is the most common procedure performed to restore blood flow in these blocked arteries. However, post-angioplasty dissection often occurs at the treatment site, which increases the risk of thrombotic occlusion. The Tack device is designed to restore tissue apposition at the site of post-angioplasty dissection. The Tack Endovascular System™ has been designed: 1) to leave minimal foreign material in the artery, 2) to apply only the minimum outward force required to reestablish tissue apposition within the lumen, and 3) to allow “spot” treatment only where needed. The System is composed of a delivery catheter containing three self-expanding nitinol Tacks.
Assistant Professor Dr. Christian Wissgott, Deputy Chief, Institute of Diagnostic and Interventional Radiology, WestkuestenklinikumHeide, Germany, who was a leading enroller in the trial, said, “Critical limb ischemia is a devastating and costly disease that demands new, innovative treatments. Completion of the TOBA-BTK trial is an important step toward developing an important new tool that could ultimately save the limbs of patients suffering from CLI.”
Dr. Peter Schneider, Intact Vascular Chief Medical Officer and Chief, Vascular Therapy at Kaiser Foundation Hospital in Honolulu, said, “Our best method for salvaging threatened limbs is to revascularize them using balloon angioplasty, but the current technique has limitations. The Tack Endovascular System has the potential to substantially improve outcomes for CLI patients by optimizing angioplasty.”
About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products, and is dedicated to improving the lives of patients who suffer from peripheral vascular disease. The Tack Endovascular System™ is designed to optimize balloon angioplasty results in the treatment of peripheral artery disease. Visit www.intactvascular.com for more information.