QualiMed's QBX 5-F–Compatible QBX Stent Implanted for First Time in Iliac Artery Via Ulnar Approach

March 22, 2016—QualiMed Innovative Medizinprodukte GmbH announced the first implant of the company’s QBX 5-F–compatible balloon-expandable stent in the iliac artery via an ulnar approach. Carlo Trani, MD, Head of the Interventional Cardiology Unit, Cardiovascular Science Department, at the Catholic University of the Sacred Heart in Rome, Italy, successfully implanted the 9- X 26-mm–diameter stent in a left common iliac artery through a left ulnar artery approach with a 6-F guiding catheter using a 5-in-6 Slender sheath (true 5-F access).

In the company’s press release, Dr. Trani commented, “True 5-F access was never before possible until now for large-diameter iliac stents, and this marks a significant advancement for interventionist and the patients they treat.”

The flexible, balloon-expandable QBX 5-F stent, which is made of cobalt chromium alloy, received European CE Mark approval in 2015. The QBX 5-F stent system is indicated for primary stenting of de novo or restenotic lesions of the peripheral arteries.

Using the company’s microinvasive technology, the device is designed for peripheral vessel diameters from 5 to 10 mm. The QBX 5-F is mounted on a 0.018-inch over-the-wire delivery system and is available in a full range of diameters and lengths.

According to the company, the device provides a means of safely advancing the stent through the peripheral vessels to the desired location through a 5-F introducer or a 6-F guide catheter, so it can be used in various radial or brachial applications. It can also be used effectively in femoral access cases, reducing the puncture site diameter and puncture site surface area by minimizing the device entry and crossing profiles of 5 F or less while maintaining device functionality.

By reducing the profile and maintaining functionality, the device allows for significant reduction of vascular access site complications, with the potential to eliminate the need and cost associated with vascular closure devices, advised QualiMed.