FDA Approves TOBA II BTK Pivotal IDE Clinical Study

Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the U.S. Food and Drug Administration (FDA) granted staged approval for the Company’s Investigational Device Exemption (IDE) application to begin its Tack Optimized Balloon Angioplasty II BTK (“TOBA II BTK”) clinical study. The study will examine the safety and efficacy of the Tack Endovascular System when used to repair dissections (or tears) in the arteries below the knee (BTK) following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischemia (CLI).
 
Patrick J. Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine of St. Louis, and George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC REX Hospital, Raleigh, N.C., are national Principal Investigators for the study. Doctors Geraghty and Adams bring a wealth of experience with the endovascular treatment of peripheral artery disease and with the design and conduct of clinical trials for endovascular therapies.
 
The TOBA II BTK study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. Patients experiencing symptoms from advanced peripheral artery disease below the knee will be eligible. Frequently termed CLI, this condition often results in severe disability including pain, chronic wounds, gangrene and amputation. Study subjects will be treated with the Tack Endovascular System following standard balloon angioplasty in the popliteal or tibial arteries when a dissection occurs.
 
Bruce J. Shook, president and CEO at Intact Vascular, stated, “The TOBA II BTK clinical study represents an exciting opportunity to bring the first vascular implant to the U.S. market for the treatment of critical limb ischemia patients. We are thrilled with the level of enthusiasm from the clinical community and look forward to collaborating with them on this important advancement for CLI care.”

In July 2016, promising 12-month results from the TOBA study, which examined use of the Tack implant to treat dissections above the knee, were published in the Journal of Vascular Surgery¹. The 12-month results from the TOBA BTK pilot study also were released last May at the Society for Cardiac Angiography and Interventions (SCAI) 2016 Annual Meeting². Both of these studies demonstrated the potential of the Tack implant to improve arterial healing following angioplasty above and below the knee.
 
Dr. Geraghty stated, “Critical limb ischemia is a debilitating condition for many patients with serious downstream consequences such as amputation and loss of independence. The disease is growing rapidly, especially with the increasing incidence of diabetes, creating an urgent need for more effective treatments. The TOBA II BTK study represents an exciting opportunity to improve the long-term results associated with angioplasty, which is our primary, minimally invasive treatment for CLI. This study is the first pivotal trial ever conducted in the U.S. supporting the FDA approval of an implantable device for CLI treatment.”
 
Dr. Adams added, “We are very enthusiastic about the commencement of the TOBA II BTK clinical study. The Tack Endovascular System is uniquely tailored for use in arteries below the knee. These arteries are small in diameter, so the minimal metal burden associated with the Tack implant and the Tack implant’s ability to adapt to the diameter of the artery are both ideal for dissection repair in this part of the leg.”
 
References
¹Bosiers M, Scheinert D, Hendriks JM, Wissgott C, Peeters P, Zeller T, Brodmann M, Staffa R; TOBA investigators. “Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.” J Vasc Surg. 2016 Jul;64(1):109-16. doi: 10.1016/j.jvs.2016.02.043. Epub 2016 Apr 29.
²Brodmann M, Wisgott C, Holden A, Staffa R, Vasudevan T, Zeller T. “TOBA BTK 12-Month Results: A New Method for Treating CLI with Post-PTA Dissections.” Presented at the Society for Cardiac Angiography and Interventions 2016.