Journal of Endovascular Therapy, 2022 (Impact factor 3.487 source Sage Journals) with title "Stents with torsional strength for Superficial Femoral artery disease. The prospective Q3-Registry" by Thieme et al.
"The Q3 SELF-EXPANDING stent offers a novel patented Bi-Directional design providing for a new way of flexibility and torsional conformability that is highly durable and crush resistant working in unison with the anatomy.
Due to its unique globally patented Bi-Directional design the self-expanding stent works equally well when placed in the superficial femoral arteries (SFA) of the left leg or the right leg.
This unique feature of Bi-Directionality, not available in other competitive SFA devices, has now been studied and published in the Journal of Endovascular Therapy.
The 200 patient all-comers study demonstrates the benefit of the Bi-Directional design with a Freedom from cdTLR at 12 months of 94.4% and at 24 months of 88.7%. The results represent some of the best ever published in any self-expanding stent study let alone an all-comers study!
The Q3 ease of use with virtually no foreshortening and its unique patented bi-directional design for physiological vascular conformity allows operators to obtain positive long-term results for their patients," Q3 CEO Eric Mangiardi said in a prepared statement.
"This prospective multi-center, observational post market surveillance study aimed to assess the effectiveness and safety of the Q3 Bi-Directional peripheral vascular self-expanding stent.
The study focused on the treatment of de novo superficial femoral artery SFA with the primary outcome being freedom from clinically driven target lesion re-vascularization (cdTLR) at 12 months and secondary outcome being procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb event (MACLE) throughout 24 months," said Prof. Hans Krankenberg, Department of Angiology, Medinos Kliniken Sonneberg, Thüringen, Germany as PI of the study.
About QualiMed:
QualiMed was founded in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory approval of coronary stents and catheters. Later the business was expanded to peripheral vascular, non-vascular, and biodegradable implants. QualiMed is now a world leader in the development of biodegradable implants for use in minimal invasive, interventional, and open surgical applications.
To date QualiMed has obtained CE approvals for more than 70 different products. Manufacturing is organized outside of Hamburg, Germany in the town of Winsen where it has manufacturing & development expertise for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications.
For more information, visit www.q3medical.com
