The European Commission has granted CE mark approval and ISO Certification for Intact Vascular's Tack-it Endovascular Stapler device, used for treating peripheral artery disease (PAD).
The Tack-it Endovascular stapling device features a 6F multiloaded catheter containing four self-expanding tacks, designed to optimise peripheral balloon angioplasty results by creating tissue apposition to smooth the arterial lumen.
The Tack-it Endovascular stapler device has been evaluated in a clinical trial conducted in South America on 11 subjects, in whom 50 Tacks were placed.
Balloon angioplasty is the commonly performed peripheral intervention to improve blood flow in leg arteries. However, it produces suboptimal results due to an irregularly shaped lumen or tissue dissection from the angioplasty mechanism.
Intact Vascular CEO Carol Burns said: "This is a unique solution for patients, offering physicians a new paradigm for treatment. Three important concepts are at the core of co-founder Robert Giasolli's design, which includes: 1) less foreign material in the artery 2) less long term chronic injury to the vessel and 3) the ability to perform 'spot' treatment to the vessel only where needed."
Intact Vascular co-founder and chief medical officer Peter Schneider said they believe Tack-It technology will offer a new solution to address the problem.
"One of the key design features is that the device can treat a range of diameters offering tremendous versatility. This will enable physicians to go down the leg after angioplasty and spot-treat several areas using a single device," Schneider added.
Intact Vascular advisor William Gray said the one-year results are encouraging, and that the company is planning to initiate a post-CE mark clinical study within the next couple of months. Intact Vascular is a privately held medical device company which develops minimally invasive peripheral vascular products.