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Intact Vascular obtains conditional FDA approval for TOBA II trial

Medical device firm Intact Vascular has received conditional approval from the US Food and Drug Administration (FDA) for the Tack Optimized Balloon Angioplasty II (TOBA II) trial.

The US and European IDE clinical study has been designed to evaluate the Tack endovascular system as a dissection repair therapy in patients with peripheral arterial disease (PAD).

The Tack endovascular system has been developed to repair dissections, which frequently occur as a complication of balloon angioplasty.

Intact Vascular president and CEO Bruce Shook said: "We are thrilled by the enthusiasm and responsiveness of our clinical investigators, particularly Dr Cardenas and his team at Yuma.

"The rapid commencement of this trial highlights the clinical need for a better method to repair arterial dissections and the keen interest clinicians have shown in a minimal metal solution to this growing problem."

The firm has started the trial with the first patients being enrolled at Yuma Regional Medical Center in Arizona.

Around 210 subjects will be enrolled in the trial at 30 to 40 sites in the US and Europe, which will include the patients suffering from advanced PAD in one or both legs.

According to the firm, the patients will be treated with the Tack endovascular system following standard balloon angioplasty or drug-coated balloon angioplasty in the superficial femoral and proximal popliteal arteries, when a dissection occurs.