Tack Optimized Balloon Angioplasty III (TOBA III) Clinical Trial Commences Enrollment with First European Implant of the Tack Endovascular System™
WAYNE, PA – June 2, 2016 – Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty III (TOBA III) clinical trial has commenced enrollment, with the first patient treated by Prof. Klaus Brechtel at the Franziskus-Hospital in Berlin, Germany.
The TOBA III study is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with the Medtronic Admiral drug-coated angioplasty balloon in the treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. 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 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.
Prof. Brechtel stated, “One of our key goals when using drug coated balloons to perform peripheral angioplasty is to minimize inflammation of the treated artery and leave little foreign material behind. The Tack system is designed to allow us to repair arterial damage after angioplasty while minimizing vessel irritation and leaving far less metal behind than we would with the traditional stenting approach.”
The TOBA III study will be conducted at multiple sites across Europe and will enroll 200 patients in total, including a subgroup of patients with long arterial lesions. Eligible patients will have PAD treated with balloon angioplasty using the Medtronic IN.PACT 2 Admiral Drug-Coated Balloon and have a dissection in the artery wall immediately following angioplasty.
Prof. Brechtel continued, “The TOBA III trial will provide us with valuable information about the combination of two very promising technologies designed to treat PAD. We are thrilled to be the first center to begin enrollment in this important study.”
Marc Penna, Vice President of Clinical Affairs at Intact Vascular, added, “The Tack Endovascular System is the ideal adjunct to drug-coated balloon angioplasty. It allows physicians to treat arterial damage in a highly targeted way and address their goals of reducing stress and irritation on the artery. We have a robust clinical development portfolio that is designed to demonstrate the power of this technology combination on the endovascular treatment of PAD.”
Intact Vascular is also sponsoring the TOBA II study, which is investigating the combination of the Tack Endovascular System with uncoated angioplasty balloons and the BARD Lutonix® Drug-Coated Balloon in patients with superficial femoral and popliteal artery disease. Future plans include conducting the TOBA II BTK clinical trial to assess the performance of the Tack Endovascular System following balloon angioplasty in patients with arterial disease below the knee.
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.
Intact Vascular, Inc.
Andrea Dunkle, [email protected], 1-484-253-1048
Tack Endovascular System™ and Tack™ are trademarks of Intact Vascular, Inc. The Tack Endovascular System™ is CE Mark Authorized under EC Directive 93/42/EEC. Not Available for Sale in the United States.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.