Intact Vascular’s Tack Endovascular System receives FDA approval

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Intact Vascular’s Tack Endovascular System receives FDA approval

Press releases may be edited for formatting or style | April 16, 2019 Cardiology

Intact Vascular recently announced its European launch and first commercial cases in several centers across Germany. With FDA approval granted, the company plans a limited initial release in the US that will progress toward broader market commercialization.


About Intact Vascular and the Tack Endovascular System

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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 stents1. 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.


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.

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