FDAnews Device Daily Bulletin

Arch Therapeutics to Initiate Clinical Trial of AC5 in Europe

Dec. 17, 2015

Arch Therapeutics has scored clearance to initiate a clinical trial in Western Europe for its AC5 surgical hemostatic device.

The device is designed to control bleeding and fluid loss to help provide faster and safer surgical and interventional care, according to the Framingham, Mass.-based company.

The trial — which will assess the device’s safety and performance — will examine bleeding wounds created during a dermatological procedure in fewer than 50 patients.

The endpoints include product-related adverse effects and time to hemostasis. A planned patient follow-up assessment will occur 30 days following the procedure. — Michael Cipriano