QualiMed's Postmarket Q3 Registry Evaluates Polaris Bidirectional SFA Stent

June 1, 2015—QualiMed Innovative Medizinprodukte GmbH announced several milestones for its portfolio of minimally invasive interventional devices. QualiMed is a developer of interventional cardiology, peripheral vascular, and nonvascular products, as well as microinvasive interventional devices that seek to address clinical complications associated with vascular access site closure. The German-based QualiMed company is a subsidiary of Q3 Medical Devices Ltd., which is based in Dublin, Ireland.

The company has initiated the prospective, postmarket Q3 Registry to provide additional clinical validation of the performance of its bidirectional stent technology in treatment of the superficial femoral artery (SFA). The registry will enroll 250 patients with single significant (> 50%) SFA disease at nine sites in Germany to evaluate the efficacy of the device. Enrollment is expected to be completed by the end of 2015. The registry is led by principal investigator Hans Krankenberg, MD, who is from the Herz- und Gefäßzentrum Bad Bevensen in Germany.

QualiMed’s 6-F-compatible Polaris peripheral vascular self-expanding stent system received European CE Mark approval in fall 2014. The device is indicated for the primary stenting of de novo or restenotic lesions of the peripheral arteries, including the SFA. The Polaris device is distributed by Stron Medical.

According to the company, its technology allows the bidirectional Polaris SFA stent to be rotated circumferentially in either direction up to a maximum of 720º without collapse. The bidirectional implant can be delivered with an easy one-handed delivery or traditional pin-and-pull mechanism with low entry profile, good flexibility, and virtually no foreshortening or elongation, making it easy to place even in difficult anatomy ending at a bifurcation.

The device is available in diameters of 6 to 11 mm and lengths of 20 to 200 mm with catheter lengths of 80 to 120 cm. The company anticipates developing a 5-mm-diameter stent and adding a 150-cm catheter delivery device to its size range in the near future to further expand its line of microinvasive technology. 

The company has also received CE Mark approvals for a balloon-expandable stent and a self-expanding stent to treat below-the-knee lesions and below-the-ankle lesions with a specific focus for pedal retrograde delivery in critical limb ischemia patients.

In addition to the Q3 registry, the company has contracted with each of the nine sites in Germany to participate in additional clinical studies and registries focused around its microinvasive and biodegradable devices to be conducted over the next 12 to 18 months. The studies will evaluate the 4-F-compatible below-the-knee self-expandable stent implantation system (CE Mark-approved); the 5-F-compatible BX peripheral balloon-expandable stent implantation system (CE Mark approval pending); the 5-F-compatible biodegradable balloon-expandable stent implantation system (CE Mark approval expected in 2016); and the DEB 2, a second-generation drug-eluting balloon catheter that is 5-F compatible with direct ballooning (CE Mark approval expected in 2016). The company is also developing the Unity fully biodegradable stent platform, advised QualiMed.