PR94469

JENA, Germany, Feb. 9, 2022 /PRNewswire=KYODO JBN/ --

    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

    Image: https://mma.prnewswire.com/media/1743246/Concept_Medical_NASDAQ.jpg  

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

    Source: Concept Medical Inc.