 |
TAMPA, Fla., Oct. 21, 2022 /PRNewswire/ -- Concept Medical Inc. announces the successful 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 segment.
The prospective, multi-center, head-to-head, corelab adjudicated RCT enrolled a total of 480 patients across 28 sites in Germany and Austria. The target patient was enrolled on September 23, at Hanusch Hospital Vienna by PI Prof. Martin Werner and team.
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 option, followed by Paclitaxel DCB - with discouraging success due to FDA concerns and controversies over safety of Paclitaxel. Sirolimus DCB treatment is well established as a safe and effective option in both coronary and peripheral artery disease segments. Concept Medical's Magic Touch PTA Sirolimus Coated Balloon has been tested with good success in both safety and efficacy criteria in lower extremity diseases across multiple studies. Furthermore, the device is also being compared directly against POBA in other RCT, but what was required was a head on RCT against paclitaxel, to add weight to it being the better option.
SIRONA will be a game changer trial, considering its bold design and the direct comparison against paclitaxel. The trial enrolled all patients with a disease in the SFA segment, whether de-novo or restenotic, falling into Rutherford classes 2-4, and experiencing intermittent claudication to Critical Limb Ischemia (CLI). The 12 months result will feature patency (defined as the absence of TLR or restenosis), and primary safety endpoint is assessed as the composite of freedom from device or procedure-related death at 12 months as well as major target limb amputation. The complete credit extends to all the site investigators, operators, technicians and CRO for a swift and seamless enrollment and the results are much awaited.
The University Heart Center - Bad Krozingen topped the enrollment under 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," adds Prof. Thomas Zeller on this achievement.
Magic Touch PTA has already been granted a breakthrough device designation by the US FDA for BTK indication and has a head-to-head RCT ongoing as well against paclitaxel. The results from SIRONA, will surely play a significant role in shifting the scale towards Sirolimus and a perspective and opinion shift for the fraternity, if not less.
About Magic Touch PTA:
Magic Touch PTA is a CE approved and commercially marketed sirolimus DCB, developed using proprietary Nanolute Technology – the drug delivery technology platform of Magic Touch PTA balloon, is designed to deliver sub-micron particles of sirolimus to reach the deepest layers of the vessel walls.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug/pharmaceutical agent across the luminal surfaces of blood vessels.