TAMPA, Fla., Oct. 24, 2022 /PRNewswire/ — Concept Medical Inc. announces the successful completion of SIRONA, the world’s first and largest RCT investigating the use of sirolimus drug-coated balloon (DCB) (Magic Touch PTA – Concept Medical Inc.) versus Paclitaxel DCB angioplasty for the treatment of peripheral artery disease in the femoropopliteal vascular segment.
A total of 480 patients at 28 centers in Germany and Austria participated in the prospective, multicenter, face-to-face, laboratory-adjudicated RCT. The target patient was registered on September 23 at the Hanusch Hospital in Vienna, under the care of Prof. Martin Werner and his team.
Prof. Dr. Ulf Teichgräber stated: “As coordinating PI I am delighted to be working with 28 very dedicated and motivated study centers that have managed to complete enrollment much sooner than expected. SIRONA represents a cutting-edge RCT with the potential to set the standard for beginning of a new era of Sirolimus DCB in PAD to replace an old technology.”
Old fashioned plain balloon angioplasty (POBA) has been the most widely used treatment option, followed by Paclitaxel DCB, with disappointing success due to FDA concerns and controversies over the safety of paclitaxel. Sirolimus DCB treatment is well established as a safe and effective option in the coronary and peripheral artery disease segments. Concept Medical’s Magic Touch PTA sirolimus-coated balloon has been successfully tested on both safety and efficacy criteria in lower extremity disease in multiple studies. In addition, the device is also being directly compared to POBA in other RCTs, but what was needed was a head-on RCT against paclitaxel, to add weight to it being the best option.
SIRONA will be a game-changing trial, considering its bold design and direct comparison with paclitaxel. All patients with SFA segment disease, either de-novo or restenotic, belonging to Rutherford classes 2-4, and experiencing intermittent claudication up to critical limb ischemia (CLI) were enrolled in the trial. The outcome at 12 months will present patency (defined as no TLR or restenosis), and the primary safety endpoint is assessed as the composite of no device- or procedure-related death at 12 months, as well as as major amputation of the target limb. Credit goes to all of the center’s investigators, operators, technicians, and the CRO for a quick and seamless enrollment, and the results are highly anticipated.
The University Heart Center – Bad Krozingen led the enrollment under the direction of Professor Thomas Zeller.
“It is exciting that enrollment in the first comparative study between a sirolimus-coated DCB and a variety of paclitaxel-coated DCBs marketed for femoropopliteal indications has been completed in such a short time. The study is large enough and powerful enough to demonstrate whether there is at least equivalent performance between Magic Touch DCB and a range of paclitaxel-coated DCBs and, if so, whether there are potential lesions that may even benefit from the use of a sirolimus-coated DCB,” Professor Thomas Zeller added of this achievement.
Magic Touch PTA has already received Breakthrough Device Designation from the US FDA for the BTK indication and has an ongoing RCT against paclitaxel. The SIRONA results will surely play a major role in shifting the scale towards Sirolimus and a change of perspective and opinion for the fraternity, if not less.
About Magic Touch PTA:
Magic Touch PTA is a commercialized, CE approved sirolimus DCB developed using proprietary Nanolute technology – the Magic Touch PTA balloon drug delivery technology platform, is designed to deliver sub-micron particles of sirolimus to reach the deepest layers of the the walls of the vessels.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida with operational offices in the Netherlands, Singapore and Brazil, as well as manufacturing units in India. CMI specializes in the development of drug delivery systems and has unique and proprietary technology platforms that can be deployed to deliver any drug/pharmaceutical agent across the luminal surfaces of blood vessels.
www.conceptmedical.com
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