Concept Medical Completes Enrollment in SIRONA Trial of MagicTouch DCB

October 21, 2022—Concept Medical Inc. announced the completion of enrollment in the SIRONA randomized controlled trial (RCT), which is investigating percutaneous transluminal angioplasty (PTA) with the company’s MagicTouch sirolimus drug-coated balloon (DCB) versus paclitaxel DCBs for the treatment of peripheral artery disease (PAD) in the femoropopliteal vessel segment.

According to Concept Medical, SIRONA is a prospective, multicenter, head-to-head, core lab–adjudicated RCT that enrolled 480 patients at 28 sites in Germany and Austria.

Patients in the trial had de novo or restenotic disease in the superficial femoral artery segment, with Rutherford classifications of 2 to 4 and experiencing intermittent claudication to critical limb ischemia.

The primary endpoint is 12-month patency, defined as the absence of target lesion revascularization or restenosis. The primary safety endpoint is the composite of freedom from device- or procedure-related death at 12 months and major target limb amputation.

Professor Ulf Teichgräber, MD, of Jena University Hospital in Jena, Germany, commented in the company’s press release, “As coordinating Principal Investigator, 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.”

Professor Thomas Zeller, MD, who led investigators at Universitäts-Herzzentrum Freiburg-Bad Krozingen in Bad Krozingen, Germany, added, “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 DCBs for femoropopliteal indication could be finished in such a short time.”

Prof. Zeller continued, “The study has sufficient size and the power to demonstrate if there is at least equivalent performance between the MagicTouch 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.”

Concept Medical noted that MagicTouch features the company’s nanolute technology platform that delivers submicron particles of sirolimus to reach the deepest layers of the vessel walls.

In 2019, Concept Medical announced MagicTouch PTA received CE Mark approval in Europe and FDA Breakthrough Device designation for treatment of PAD below the knee.