WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to 6 months.
The TOBA II BTK study enrolled its first patient in February, 2017 and is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system is intended to provide physicians with an alternative for repair of dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.
“We are very pleased with FDA’s decision to approve our supplemental application to modify the primary endpoint to 6 months,” said Bruce Shook, Intact Vascular’s President and CEO. “We believe that this will help accelerate the availability of the Tack Endovascular System in the U.S. as an important new endovascular treatment for patients suffering from below the knee arterial disease.”
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack® device with both plain and drug-coated balloon angioplasty in the arteries above the knee. TOBA II BTK is investigating the combination of the Tack device 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 drug-coated balloon angioplasty. Visit http://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.
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.
Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
