Intact Vascular Announces US Launch of the Tack Endovascular System® and First Commercial Use

WAYNE, Pa.--(BUSINESS WIRE)-- Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System in multiple sites across the United States. Recently FDA-approved for above-the-knee interventions, the first-of-its-kind dissection repair device is implanted post-angioplasty to resolve dissections in patients with peripheral arterial disease (PAD).

“Dissections are an unavoidable consequence of balloon angioplasty. Now, with the Tack Endovascular System, we have an effective minimal metal solution to treat dissections above-the-knee, further improving our angioplasty outcomes,” stated Dr. Nicolas W. Shammas, Founder and Research Director, Midwest Cardiovascular Research Foundation in Davenport, Iowa. “I am extremely pleased with my experience using Tack^® implants and believe this device will facilitate better care for my PAD patients.”

Balloon angioplasty, whether performed with plain or drug-coated balloons, inherently injures the vessel wall, creating dissections that may inhibit blood flow and promote thrombosis formation. Despite the prevalence of dissections, they are frequently underdiagnosed and left untreated, often leading to further complications and compromised patient outcomes.

“The Tack Endovascular System brings us unique clinical and economic advantages in the office-based-lab setting. With six implants pre-loaded into a single delivery system, physicians can quickly and easily provide precision dissection repair along the vessel length,” stated Dr. John Rundback, Vascular and Interventional Radiologist and Partner at the New Jersey Endovascular & Amputation Prevention Services, LLC in Teaneck, New Jersey. “This minimal metal therapy complements balloon angioplasty and avoids the complications a larger metal stent may cause, thereby preserving future treatment options.”

“In striving to provide the best care for patients, we actively seek new ways to improve the results of balloon angioplasty,” said Dr. Ehrin Armstrong, Interventional Cardiologist and Director of Interventional Cardiology at the Rocky Mountain Regional VA Medical Center in Denver, Colorado. “Based on my clinical experience using the Tack Endovascular System, I anticipate this targeted therapy will become standard of care for post-angioplasty dissection repair.”

About Intact Vascular and the Tack Endovascular System^®

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to repair dissections following peripheral balloon angioplasty. Pre-loaded with six self-expanding nitinol implants for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents.¹ Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for peripheral arterial disease patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 implant with plain angioplasty balloons and the BD Interventional Lutonix^® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK has completed enrollment and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT^® Admiral^® (DCB), with a long lesion subset.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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.

¹Bosiers M, Scheinert D, Hendricks JMH et al. 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;64:109-16.

Tack Endovascular System^® and Tack^® are registered trademarks of Intact Vascular, Inc.
Lutonix^® is a registered trademark of BD Interventional.
IN.PACT^® and Admiral^® are registered trademarks of Medtronic, Inc.
The Tack Endovascular System^® is CE Mark Authorized under EC Directive 93/42/EEC.

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