PR91573

TAMPA, Fla., Sept. 9, 2021 /PRNewswire=KYODO JBN/ --

    ABILITY Diabetes Global

[https://www.conceptmedical.com/clinical-program/ability-diabetes-global/]

(Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus

Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes

Mellitus Global) started off with the index patient enrolment on 11th June 2020

in Italy (at the peak of the 1st wave of COVID-19 pandemic) by P.I. Prof.

Antonio Colombo and the pace of enrolment since then has been steady and

consistent, with a thousand patients being enrolled in just over a year.

    Despite COVID-19 ravaging world over, the pace of enrolment is remarkable

considering the fact that the healthcare facilities are occupied in caring for

patients hospitalized with COVID-19. Although COVID-19 crisis still looms over

us, Cardiovascular Disease (CVD) remains the number one killer and Diabetes

continues to be the key comorbidity and contributor to Coronary Artery Disease

(CAD).

    ABILITY Diabetes Global

[https://www.conceptmedical.com/clinical-program/ability-diabetes-global/] is

the world's largest Randomized Controlled Trial (RCT) for CAD patients with

diabetes as a comorbidity. This RCT measures the safety and efficacy of the

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

specially crafted with the patented Envisolution Technology and has proven to

be effective in managing the proliferative CAD lesions seen in DM.

   With the promising pace of enrolment so far, Concept Medical

[https://www.conceptmedical.com/] eagerly looks forward to the completion and

results of ABILITY Diabetes Global targeting more than 3000 diabetic patients,

across 100 centres, spanning more than 25 countries against the XIENCE EES

family (Abbott Cardiovascular).

   Concept Medical is delighted to be a part of this achievement which is a

direct result of endless support, guidance, and experience of Prof. Roxana

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

Alexandre Abizaid, Prof. Antonio Colombo & Prof. Shigeru Saito (Principal

Investigators), and the entire steering committee. Contributing to this

achievement are the sites who showed encouragement in participation with the

top enrollers so far being - Instituto Dante Pazzanese, Sao Paulo, Brazil (Dr.

Chamié), National Heart Foundation Hospital and Research Institute, Dhaka,

Bangladesh (Prof. Malik), Herzzentrum Segeberger Kliniken, Bad Segberg, Germany

(Dr. Allali) and many more. It is the dedication and commitment of all the

sites, the site investigator, and technicians for accomplishing this. The

credit also extends to Cardiovascular European Research Center (CERC), Mount

Sinai and ICAHN School of Medicine for their valuable contribution and constant

coordination every day which is of utmost importance.

   At this point, when the trial is proceeding with excellent engagement from

its investigators, and coordinators. Prof. Mehran expresses her enthusiasm, "I

am encouraged by the progress we are making on this largest trial in PCI and

Diabetes and incredibly enthusiastic about the future of what we can offer to

these complex patients with progress in innovation in PCI."

   Prof. Marie-Claude Morice, CEO of CERC expresses her thoughts, "The CERC

team is pleased to work hand in hand with the Mount Sinai and the Concept

Medical team.  We are extremely proud to achieve this important milestone. This

study is significant for Diabetic patients with coronary disease who continue

to be treated sub optimally with current devices. The 'non-COVID' patients

should not be ignored during pandemic period. Thanks to the highly motivated

investigators and study coordinators, we were able to obtain consent from the

respective ethics committees which enabled us to enroll 1000 patients at such a

fast pace."

   For a company with the vision of Advancing Innovation, the 1000 patient

enrolment is a significant milestone towards a possible breakthrough in the

medical device industry. Concept Medical [https://www.conceptmedical.com/]

looks to progress rapidly and add one more milestone to its credit.

   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

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:

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

   Source: concept Medical Inc.