TAMPA, Fla., Oct. 21, 2022 /PRNewswire/ — Concept Medical Inc. pronounces the profitable completion of the SIRONA – World’s first and the largest head-to-head RCT investigating the use of Sirolimus Drug Coated Balloon (DCB) (Magic Touch PTA – Concept Medical Inc.) V/S Paclitaxel DCB angioplasty for the treatment of peripheral artery disease in the femoropopliteal vessel section.
The potential, multi-middle, head-to-head, corelab adjudicated RCT enrolled a complete of 480 sufferers throughout 28 websites in Germany and Austria. The goal affected person was enrolled on September 23, at Hanusch Hospital Vienna by PI Prof. Martin Werner and group.
Prof. Dr. Ulf Teichgräber states, “As coordinating PI I am thrilled to work with 28 highly dedicated and motivated study sites that have managed to complete enrollment much earlier than expected. SIRONA represents a breakthrough head-to-head RCT with the potential to usher in a new era of Sirolimus DCB in PAD to replace an old technology.”
Plain Old Balloon Angioplasty (POBA) has been the go-to treatment possibility, adopted by Paclitaxel DCB – with discouraging success as a consequence of FDA considerations and controversies over security of Paclitaxel. Sirolimus DCB treatment is properly established as a protected and efficient possibility in each coronary and peripheral artery disease segments. Concept Medical’s Magic Touch PTA Sirolimus Coated Balloon has been examined with good success in each security and efficacy standards in decrease extremity illnesses throughout a number of research. Furthermore, the system can also be being in contrast straight in opposition to POBA in different RCT, however what was required was a head on RCT in opposition to paclitaxel, so as to add weight to it being the higher possibility.
SIRONA can be a recreation changer trial, contemplating its daring design and the direct comparability in opposition to paclitaxel. The trial enrolled all sufferers with a disease in the SFA section, whether or not de-novo or restenotic, falling into Rutherford courses 2-4, and experiencing intermittent claudication to Critical Limb Ischemia (CLI). The 12 months consequence will characteristic patency (outlined as the absence of TLR or restenosis), and first security endpoint is assessed as the composite of freedom from system or process-associated dying at 12 months in addition to main goal limb amputation. The full credit score extends to all the website investigators, operators, technicians and CRO for a swift and seamless enrollment and the outcomes are a lot awaited.
The University Heart Center – Bad Krozingen topped the enrollment below the lead of Prof. Thomas Zeller.
“It is exciting that enrollment into the first head-to-head comparative study between a sirolimus coated DCB and a variety of marketed paclitaxel coated DCB for femoropopliteal indication could be finished in such a short time. The study has sufficient size and the power to demonstrate if there is at least equivalent performance between the Magic Touch DCB and a range of paclitaxel coated DCB and if so, if there are potential lesions which may even benefit from the use of a sirolimus coated DCB,” provides Prof. Thomas Zeller on this achievement.
Magic Touch PTA has already been granted a breakthrough system designation by the US FDA for BTK indication and has a head-to-head RCT ongoing as properly in opposition to paclitaxel. The outcomes from SIRONA, will certainly play a major position in shifting the scale in direction of Sirolimus and a perspective and opinion shift for the fraternity, if not much less.
About Magic Touch PTA:
Magic Touch PTA is a CE authorized and commercially marketed sirolimus DCB, developed utilizing proprietary Nanolute Technology – the drug supply know-how platform of Magic Touch PTA balloon, is designed to ship sub-micron particles of sirolimus to succeed in the deepest layers of the vessel partitions.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida and has operational workplaces in The Netherlands, Singapore and Brazil and manufacturing items in India. CMI specializes in creating drug-supply techniques and has distinctive and patented know-how platforms that may be deployed to ship any drug/pharmaceutical agent throughout the luminal surfaces of blood vessels.
www.conceptmedical.com
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