Concept Medical Inc., (https://www.conceptmedical.com/) focused on vascular 
intervention drug delivery devices, releases the second status update of SIRONA 
RCT (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting 
BallooN Angioplasty in the Femoropopliteal Artery), as the trial completes half 
the targeted enrolment.

    SIRONA (https://www.conceptmedical.com/press-release/sirona/)is the world's 
first and the largest head-to-head RCT investigating the use of Sirolimus DCB 
(Magic Touch PTA (https://www.conceptmedical.com/product/magic-touch-pta/)– 
Concept Medical) V/S Paclitaxel DCB (CE certified devices) for the treatment of 
femoropopliteal occlusive artery disease. The Investigator-Initiated and driven 
trial led by PI Prof. Dr. Ulf Teichgräber of the Jena University Hospital aims 
to evaluate the safety and efficacy of Sirolimus DCB against Paclitaxel DCB in 
stenosed or occluded lesions in the superficial femoral artery (SFA), and/or 
popliteal artery (P1) in PAD patients with Rutherford class 2-4. 

    The prospective, multi-center, corelab adjudicated randomized trial is 
doing very well with the 239th patient enrolled on November 23, 2021, in 
University of Graz by Prof. Dr. Marianne Brodmann, making the trial already 
halfway into the target of enrolling 478 patients set to be randomized in 1:1 
fashion across 30 sites in Germany and Austria. Under the focused leadership of 
the PI, and the enthusiastic Site Investigators and operators the trial has 
reached to this milestone showcasing the brisk pace of enrollment despite Covid 
– 19 impacting and disturbing healthcare facilities and people world over. 

    The significance of the trial has been a point of discussion since its 
on-set, considering how its result will play a major role in deciding the 
future treatment options for lower extremity diseases with the recent 
controversies against the use of Paclitaxel. The need for a head-to-head RCT 
has been stressed many times and this RCT seeks to give the intervention 
fraternity a re-evaluation of the available treatment options.

    SIRONA touched the goal of 50 percent recruitment within a short span of 
seven months, and the absolute credit goes to the PI and the sincere efforts of 
all the site investigators especially the top enrollers, which resulted in the 
encouraging rate of enrollment. Concept Medical Inc. 
(https://www.conceptmedical.com/ ) (Sponsor of Magic Touch PTA 
(https://www.conceptmedical.com/product/magic-touch-pta/)) extends its 
appreciation for their constant and consistent contribution in achieving this 
milestone. Prof. Thomas Zeller, site investigator of Universitäts-Herzzentrum 
Freiburg, Bad Krozingen, Germany; the leading enroller expresses his thoughts 
on the importance of the trial: "SIRONA trial substantially contributes to 
evaluate the effectiveness of an alternative antiproliferative coating 
(sirolimus) for balloon catheters to treat femoro-popliteal stenoses and 
occlusions compared to the current gold standard of a paclitaxel coating. 
Especially with regard to the still ongoing safety discussion, SIRONA 
represents the first head-to-head comparison and therefore, is of high 
scientific and clinical relevance, and is fortunately widely accepted by study 
patients as the recruitment status demonstrates"

    Reaching this important juncture and halfway already in the trial, PI Prof. 
Dr. Ulf Teichgräber shares his thoughts: "I am convinced that SIRONA represents 
a Game Changer Trial for the peripheral artery disease."
    
    Paclitaxel, with its limited success, has been the go-to treatment option 
in the past. Sirolimus is emerging as a better treatment option for PAD. 
SIRONA, the world's first and largest RCT will collect the necessary additional 
evidence on safety and efficacy of Sirolimus DCB – Magic Touch PTA, which has 
already been granted breakthrough device designation by the US FDA for 
Below-The-Knee PAD indication. Looking at the promising pace of enrollment, 
this pioneering trial will unfold the data to support and decide the safety and 
efficacy of Sirolimus DCB V/S Paclitaxel DCB (DCB is already exhibiting clear 
superiority over conventional balloon angioplasty in numerous studies).


    About Magic Touch PTA:
    Magic Touch PTA (https://www.conceptmedical.com/product/magic-touch-pta/) 
is the first drug-coated balloon, that has been assigned a "Breakthrough Device 
Designation" by the U.S. Food and Drug Administration (FDA), for the treatment 
of Below-the-knee lesions in PAD. Magic Touch PTA is a CE approved and 
commercially marketed sirolimus coated balloon, developed using proprietary 
Nanolute Technology (https://www.conceptmedical.com/technology/nanolute/)– 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.

    www.conceptmedical.com
 
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    Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg 

    Source: Concept Medical Inc.