18 January 2017 - - US-based medical device company Intact Vascular, Inc has attained the CE (Conformité Européenne) Mark for the Tack Endovascular System to repair arterial dissections following percutaneous transluminal angioplasty below the knee, the company said.

This extended indication in the European Union enables the use of the Tack system in the tibial arteries between the knee and ankle.

According to the company, the unique mechanical design of the Tack implant allows it to be used in arteries ranging from 1.5 mm to 4.5 mm in diameter.

Unlike stents, which have to be precisely sized to the artery where they will be placed, the Tack implant adapts to the diameter of the artery.

The CE Mark is supported by a comprehensive review of the data from the TOBA BTK clinical study and extensive in vitro testing. The TOBA BTK study examined use of the Tack device to repair dissections in tibial arteries following PTA.

This study demonstrated 78.4% 12-month patency and a 93.5% freedom from re-intervention in arteries treated with PTA and the Tack device. The TOBA BTK results were presented in May 2016 at the Society for Cardiovascular Angiography and Intervention annual meeting and are pending publication.

Intact Vascular also recently announced Food and Drug Administration approval of an Investigational Device Exemption for the TOBA II BTK study. The TOBA II BTK trial is the first pivotal trial approved by the FDA for the treatment of CLI with a vascular implant below the knee.

The company develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize percutaneous balloon angioplasty results in the treatment of peripheral arterial disease.