Intact Vascular Release: FDA Approves TOBA II BTK Pivotal IDE Clinical Study

WAYNE, Pa.--(BUSINESS WIRE)--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).

“TOBA BTK 12-Month Results: A New Method for Treating CLI with Post-PTA Dissections.”

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.”

About the Tack Endovascular System

The Tack Endovascular System is a new technology designed to repair dissections that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. When dissections are left unrepaired, they increase the probability of acute blockage or repeat narrowing of the artery.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System^® is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Under U.S. Federal Law, the Tack Endovascular System is Limited to Investigational Use only, in the TOBA II (ATK) and TOBA II BTK studies.

Tack Endovascular System^® and Tack^® are registered trademarks of Intact Vascular, Inc.

The 6 French (ATK) Tack Endovascular System^® is CE Mark Authorized under EC Directive 93/42/EEC. (4 French BTK pending) Not Available for sale or use in the United States.

¹ Bosiers 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.

² Brodmann 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.