Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has completed enrollment. A total of 210 patients have been enrolled in TOBA II at 33 sites in the U.S. and Europe.
The TOBA II trial is a prospective, multi-center, two-arm, non-randomized study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard or drug coated balloon (DCB) angioplasty in the arteries above the knee. Target vessels include the superficial femoral artery (SFA) and the proximal segment of the popliteal artery. The Tack Endovascular System is a new technology designed to repair dissections (or tears) in artery walls that frequently occur as a complication of standard or DCB angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.
The design of TOBA II is unique in that it permits use of the Tack® system following either standard (uncoated) balloon angioplasty or drug coated balloon angioplasty using the BARD Lutonix® DCB. Patients are enrolled in either group based upon the treating physician’s clinical judgement. The primary effectiveness endpoint for TOBA II is Duplex derived patency at 12-months following treatment.
Dr. William Gray, System Chief of the Main Line Health Cardiovascular Disease Division, is the National Principal Investigator for the TOBA II study and stated, “TOBA II is a unique clinical study which will give us important insights into a new approach to dissection repair that holds great promise for advancing the endovascular treatment of peripheral artery disease. I extend my sincere appreciation and congratulations to all of the investigators and their teams for making the timely achievement of this milestone possible.”
Dr. Peter Schneider, a Honolulu vascular surgeon and Intact Vascular’s Co-Founder and Chief Medical Officer, added, “The Tack Endovascular System was conceived as a minimal metal approach to dissection repair, and that idea has become even more important with the advent of drug coated balloon angioplasty. The completion of TOBA II enrollment is an exciting step toward FDA approval and ultimately making the Tack Endovascular System broadly available to patients suffering from peripheral arterial disease.”
Intact Vascular is also sponsoring the TOBA II BTK and TOBA III studies. TOBA II BTK is investigating the combination of the Tack Endovascular System with plain balloon angioplasty in the arteries below the knee. TOBA III is currently underway in Europe and is investigating the combination of the Tack Endovascular System with the Medtronic IN.PACT® Admiral® Drug-Coated Balloon. Visit http://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of PAD.