Concept Medical Announces Completion of Patient Enrollment in SIRONA Trial Evaluating Magic Touch PTA Sirolimus-Coated Drug-Coated Balloon for Femoropopliteal Artery Disease

Tampa, FloridaOctober 24, 2022/PR Newswire/ --Concept Medical Inc.Announcing the successful completion of SIRONA – the world's first and largest head-to-head randomized controlled trial (RCT) for the Sirolimus Drug-Coated Balloon (DCB) (Magic Touch PTA– Concept Medical Inc.) usage survey. And a head-to-head RCT of paclitaxel DCB angioplasty for the treatment of peripheral arterial disease in the femoropopliteal segment.

This prospective, multicenter, head-to-head, core-lab adjudicated RCT recruited a total of 480 patients across 28 research centers in Germany and Austria. The target patient was enrolled on September 23 at Hanusch Hospital in Vienna by Principal Investigator Professor Martin Werner and his team.

Professor Ulf Teichgräber, PhD, stated: "As the coordinating principal investigator, I am delighted to collaborate with 28 dedicated and motivated research centers, whose efforts have overcome challenges and completed recruitment much earlier than expected. SIRONA is a groundbreaking head-to-head RCT that is expected to usher in a new era of using sirolimus DCB for the treatment of peripheral artery disease (PAD), replacing older technologies."

'Plain Old Balloon Angioplasty' (POBA) has always been the preferred treatment option, followed by paclitaxel DCB, which has a low success rate due to FDA concerns and controversies over the safety of paclitaxel. Sirolimus DCB therapy has emerged as a safe and effective choice in the field of coronary and peripheral artery disease. Concept Medical's Magic Touch PTA sirolimus-coated balloon has demonstrated significant success in treating lower limb diseases in multiple studies, meeting safety and efficacy standards. Additionally, this device has been directly compared with POBA in other RCTs, but what is needed are head-to-head RCTs comparing it with paclitaxel to strengthen its position as the better option.

Considering its bold design and direct comparison with paclitaxel, SIRONA will be a game-changing trial. The trial enrolled all patients with SFA segment disease, whether de novo or restenotic, classified as Rutherford 2-4, with severe limb ischemia (CLI) caused by intermittent claudication. The 12-month outcomes will evaluate: patency (defined as absence of TLR or restenosis), a composite of 12-month freedom from device- or procedure-related death, and the major safety endpoint of major target limb amputation. Thanks to all researchers, operators, technicians, and the CRO for swiftly and seamlessly completing recruitment—we highly anticipate the study results.

Under the leadership of Professor Thomas Zeller, the Cardiac Center at Bad Krozingen University took the lead in recruitment efforts.

"Excitingly, the recruitment for the first head-to-head comparative study between sirolimus-coated DCBs and various marketed paclitaxel-coated DCBs was completed in such a short time. The study is large and powerful enough to demonstrate whether the Magic Touch DCB performs at least equally to a range of paclitaxel-coated DCBs, and if so, whether there are potential lesions that might even benefit from the use of sirolimus-coated DCBs," commented Thomas Zeller on this achievement.

Magic Touch PTAIt has received the FDA's Breakthrough Device Designation for the BTK indication in the United States and is currently conducting a head-to-head RCT with paclitaxel. The results of the SIRONA study are bound to play a significant role in tipping the scales towards sirolimus and will bring about a shift in perspective and viewpoint, at the very least.