PR98416

TAMPA, Fla., Oct. 21, 2022 /PRNewswire=KYODO JBN/ --

    Concept Medical Inc. [https://www.conceptmedical.com/] 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 [https://www.conceptmedical.com/product/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 [https://www.conceptmedical.com/product/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 [https://www.conceptmedical.com/product/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

[https://www.conceptmedical.com/] 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.

    www.conceptmedical.com

    Photo: https://mma.prnewswire.com/media/1926791/SIRONA_Enrollment.jpg

    Logo: https://mma.prnewswire.com/media/1926812/Concept_Medical_Logo.jpg

    Source: Concept Meddical Inc.