April 15, 2019 – Intact Vascular Inc. received U.S. Food and Drug Administration (FDA) market clearance for the Tack Endovascular System. This is a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).
Regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated the safety and effectiveness of the Tack implant to resolve dissections following angioplasty. Data from the pivotal trial were presented in a late-breaking scientific session at the 2018 VIVA conference.
“I look forward to having the Tack implant available for my patients,” said William Gray, M.D., system chief, Division of Cardiovascular Disease at Main Line Health, president, Lankenau Heart Institute and principal investigator for the TOBA II trial. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”
The inflation of an angioplasty balloon and resulting mechanical stress inherently injures vessels and creates dissections. These dissections are prevalent, underdiagnosed and underestimated. If left untreated, dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.
The TOBA II pivotal trial, notably the first peripheral vascular study to enroll patients with 100 percent dissected vessels, met all primary endpoints with 92 percent of dissections completely resolved following treatment. In this challenging patient population, the Tack implant demonstrated 79.3 percent K-M vessel patency and 86.5 percent K-M freedom from clinically driven reintervention at 12 months, with only a 0.5 percent bailout stent rate and zero implant fractures.
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.
For more information: www.intactvascular.com
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1. Bosiers 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.
2. Intact Vascular Announces Positive One-Year Data from the TOBA II Clinical Trial. AP News, Business Wire. Nov. 6, 2018. www.apnews.com/49f66baac3834c8a80bcf8351fccd855.