PR98067

TAMPA, Fla., Sept. 28, 2022 /PRNewswire=KYODO JBN/-

    ABILITY DIABETES-GLOBAL

[https://www.conceptmedical.com/clinical-program/ability-diabetes-global/](ADG),

is the World's largest Randomized Controlled Trial (RCT) for patients with DM

(Diabetes Mellitus), comparing head-to-head the Sirolimus eluting stent ,

Abluminus DES+ (Concept Medical Inc.[https://www.conceptmedical.com/]) with the

XIENCE family of DES (Abbott Cardiovascular).

    Diabetes has been the Achilles heel for any vascular interventional

procedures and there is a clinical need for adequately powered RCTs. The

prospective, randomized, open-label, 2-arm parallel-group RCT has enrolled a

mammoth 3050 diabetic patients. The RCT is steered by Prof. Roxana Mehran

(Chairperson), Prof. Marie-Claude Morice (Medical Director), Prof. Alexandre

Abizaid, Prof. Antonio Colombo & Prof. Shigeru Saito (Principal Investigators).

    The primary endpoints of the planned RCT are TLF (composite of cardiac

death, MI or ischemia-driven TLR) powered for non-inferiority and

ischemia-driven TLR at 1- year FU powered for non-inferiority and sequential

superiority for diabetic patients.

    "In the face of the pandemic, the completion of enrollment of the ABILITY

DM study marks an important milestone in the largest ever prospective

randomized clinical trial in patients with Diabetes Mellitus. This signifies a

crucial juncture in providing real-time and current evidence with Abluminus

DES+ [https://www.conceptmedical.com/product/abluminus-des/](with DCB)

technology pitched against the best-in-class DES," reflected Roxana Mehran.

    Prof. Antonio Colombo shares similar sentiments. "We completed enrollment

of a landmark trial. The first trial comparing two different DES in 3050

diabetics. The results will be a benchmark for any new or old PCI technology,"

he said.

    "I would like to thank all the site investigators, operators, technicians,

and study coordinators, the Cardiovascular European Research Center (CERC), and

Mount Sinai and ICAHN School of Medicine who played a stellar role in achieving

this," exuded Prof. Marie-Claude Morice (CERC), "in particular the CERC and

Mount Sinai research team who conducted the trial so well at such a complex

time; their commitment is unique and will contribute to the success of the

trial, a potentially significant improvement for Diabetic patients with

cardiovascular disease".

    Instituto Dante Pazzanese de Cardiologia (Brazil) led by Dr Daniel Chamié,

and the National Heart Foundation Hospital & Research Centre (Bangladesh), led

by Dr Fazila Malik, played a major role in completing the enrollment followed

by OLVG (The Netherlands) led by Dr Maarten Vink.

    Abluminus DES+[https://www.conceptmedical.com/product/abluminus-des/]

(Concept Medical Inc.), which has regulatory approvals in Europe and other

countries, uses a proprietary Envisolution technology

[https://www.conceptmedical.com/technology/envisolution/]to provide homogenous

drug delivery by coating the stent surface and exposed parts of the balloon and

on the edges of the balloon. In clinical studies conducted at other centers

Abluminus DES+ has proven effective in managing patients with DM.

    Prof. Alexandre Abizaid, who has widely used the product, "I would like to

congratulate Concept Medical and all the investigators for completing the

largest randomized trial in PCI for diabetic patients. This 3000-patient trial

tested a novel DES technology called Abluminus which is the combination of a

Sirolimus eluting stent crimped on a drug coated balloon. This is certainly a

landmark study in the modern era of complex coronary intervention".

    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.

    www.conceptmedical.com　

    Photo: https://mma.prnewswire.com/media/1909778/Ability_Diabetes_Global.jpg

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

    Source: Concept Medical Inc.