PR97266

MÜNSTER, Germany, July 29, 2022 /PRNewswire=KYODO JBN/ --

Concept Medical Inc. [https://www.conceptmedical.com/], a pioneer in developing

drug delivery device platforms for vascular intervention, has announced the

initiation of LIMES trial.

    LIMES (Prospective Multi-Center Randomized Controlled Trial to Evaluate the

Safety and Efficacy of SiroLIMus Drug Coated Balloon versus Standard

Angioplasty for the Treatment of Infrapopliteal Occlusions in Patients with

PEripheral Arterial DiSease) has already enrolled 15 patients, which is

encouraging as the Company looks to take a leap in the peripheral artery

disease (PAD) treatment.

    Initiated by the University Hospitals Jena and Leipzig in Germany and led

by Principal Investigator (PI) Prof. Dr. Ulf Teichgräber alongside Co-PI Prof.

Thomas Zeller and Prof. Dierk Scheinert, LIMES is a prospective, multicentre,

randomized controlled trial (RCT) which is designed and aimed to evaluate Magic

Touch – PTA 0.014" and 0.018" (Concept Medical Inc

[https://www.conceptmedical.com/]) versus POBA (Plain Old Balloon Angioplasty)

in a head-to-head comparison (1:1). The trial kicked off with the index patient

enrolled on 31st March 2022 by PD Dr. Nassan Malyar at the University Hospital

Münster in Germany.

    LIMES RCT

[https://www.conceptmedical.com/press-release/limes-randomised-controlled-trial-

about-sirolimus-coated-balloon-in-btk-takes-the-first-stride-patient-enrolment-s

tarted/ ] is set to enroll 230 patients, randomized in 1:1 (Magic Touch-PTA :

POBA) fashion in currently 19 centres across Germany and Austria. The patient

population will include patients presenting with documented chronic critical

limb ischemia (CLI) in the target limb defined as Rutherford clinical category

(RCC) 4, 5 or 6 aged greater than or equal to 18 years. The study evaluates

patients with a reference vessel diameter (RVD) greater than or equal to 2 and

less than or equal to 4.0mm and total occlusions (100% stenosis) of the target

lesion. There is no minimal lesion length required, no lesion length limitation

and no limitation in number of used devices. Follow up will be per in-house

visits at 30 days, 6, 12, 24 and 36 months.

    The RCT will measure the efficacy of sirolimus-coated balloons in a complex

setting (CLTI) of the PAD segment (located below the P3 segment of the

popliteal artery to the tibiotalar joint) against the current standard of care,

making the trial significant and one to look forward to. The study's primary

endpoints are the composite of limb salvage and primary patency through 6

months. Adding to the importance of the RCT, the key-secondary safety endpoint

is the composite of major adverse limb events (MALE) and perioperative death

(POD) at 30 days. A blinded core lab will assess patency at 6, 12 and 24 months

by duplex ultrasound and quantitative vascular angiography (QVA) in case of any

TLR.

    Prof. Ulf Teichgräber makes a point on why the RCT is valuable in terms of

DCB intervention in infrapopliteal occlusions, "BTK revascularization deals

with the most challenging vascular territory in very sick patients. LIMES  

[https://www.conceptmedical.com/press-release/limes-randomised-controlled-trial-

about-sirolimus-coated-balloon-in-btk-takes-the-first-stride-patient-enrolment-s

tarted/ ] will solve the question if sirolimus balloon angioplasty has the

potential to become the future standard of care in BTK interventions,"

following his recent presentation at the LINC 2022.

    The RCT is drawing the attention and interest of the community considering

the complex patient cohort it will include, and the use of sirolimus-coated

balloon, which is already proving its worth in SFA against POBA and Paclitaxel

in multiple RCTs. Magic Touch PTA is the only commercially available sirolimus

DCB for PAD, which has also been granted Breakthrough Device Designation.

Paclitaxel raising second thoughts due to the safety concerns raised by the US

FDA in peripheral treatment, sirolimus is the most sought after and potential

prospective for the next alternative in PAD treatment. LIMES RCT, evaluating

the sirolimus-coated balloon in this complex setting will surely add weight and

value to Magic Touch PTA Sirolimus Coated Balloon as the future of peripheral

intervention.

    About MagicTouch PTA

    MagicTouch 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. MagicTouch PTA is a CE approved and

commercially marketed sirolimus-coated balloon, developed using proprietary

nanolute technology– the drug delivery technology platform of MagicTouch 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 [https://www.conceptmedical.com/ ] 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.

    Photo: https://mma.prnewswire.com/media/1869091/Munster_Germany_team.jpg  

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

    Source: Concept Medical Inc