April 22, 2020
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® (4F) in multiple sites across the United States. Notably the first FDA-approved vascular implant for below-the-knee post-angioplasty dissection repair, Tack® implants are designed to optimize balloon angioplasty outcomes in the challenging critical limb ischemia (CLI) patient population.
“Effectively treating the small arteries affected in CLI has always been challenging. Over the years, various technologies have attempted to address this unique vasculature, but failed to provide an effective solution,” commented John Rundback, MD, Vascular and Interventional Radiologist and Partner at the American Endovascular & Amputation Prevention Services, LLC in Clifton, New Jersey, one of the initial implanting sites. “Finally, I have an option that safely and effectively delivers better results below the knee for my CLI patients, and I am thrilled to incorporate this novel peripheral vascular implant into my treatment algorithm going forward.”
Regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial, which met all primary endpoints with 100% acute dissection resolution. The TOBA II BTK results were presented at the 2019 VIVA conference and demonstrated 95.7% K-M amputation-free survival, 87.3% K-M target lesion patency with significant improvement in toe-brachial index (TBI) and 92.0% K-M freedom from clinically driven reintervention at six months.
“As a company, Intact Vascular has sponsored multiple large-scale, prospective studies that have generated a solid and robust body of clinical evidence to support post-angioplasty dissection repair with the Tack Endovascular System,” noted S. Jay Mathews, MD, Interventional Cardiologist and Endovascular Specialist at Bradenton Cardiology Center in Bradenton, Florida, another initial implanting site. “I am confident this game-changing technology will elevate the standard of care when performing endovascular procedures.”
“I would like to acknowledge our TOBA II BTK trial investigators for their collaboration and efforts to reach this important milestone,” commented Howard Rosen, Vice President of Marketing and Business Development for Intact Vascular. “There has been a long-standing and significant unmet need for a technology that addresses below-the-knee disease. We are thrilled to provide the first FDA-approved peripheral vascular implant offering endovascular operators a novel tool that safely and effectively addresses this challenging condition and improves outcomes for their patients.”
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 devices for above-the-knee (ATK) interventions, or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind significantly less metal than stents. 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 also completed its primary endpoint analysis and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed its primary endpoint analysis and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), with a long lesion subset. To learn more about Intact Vascular’s clinical program, please visit www.intactvascular.com/clinical-studies/.
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.
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of BD Interventional.
IN.PACTTM and AdmiralTM are registered trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
The Tack Endovascular System (4F, 1.5-4.5mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
CONTRAINDICATIONS FOR USE
The Tack Endovascular System is contraindicated for the following: 1. Patients with residual stenosis in the treated segment equal to or greater than 30% after PTA. 2. Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device. 3. Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol). 4. Patients unable to receive standard medication used for interventional procedures such as anticoagulants, contrast agents and antiplatelet therapy.
SAFETY INFORMATION: https://intactvascular.com/important-safety-information/