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BIRMINGHAM, England, Sept. 13, 2022 /PRNewswire-=KYODO JBN/ --

   Concept Medical (https://www.conceptmedical.com/) announces the successful

completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels:

Randomized controlled trial FOR MagicTouch

(https://www.conceptmedical.com/product/magic-touch/) Sirolimus Coated

Balloon). The Randomized Controlled Trial (RCT) was conceptualized with the aim

of understanding how the treatment indications and applications of Drug Coated

Balloon (DCB) in coronary artery disease (CAD) can be broadened.

    https://mma.prnewswire.com/media/1897550/TRANSFORM_1_Enrollment.jpg

    On the 31st of August, Dr Sandeep Basavarajaiah and the team completed the

TRANSFORM 1 enrollment target with ease at Heartlands Hospital, Birmingham.

This prospective, randomized, multi-centre, RCT focusing on small vessels,

de-novo coronary lesion treatment enrolled the culminating 114th patient on

31st of August at Heartlands Hospital, Birmingham by Dr. Sandeep Basavarajaiah

and team completing the enrollment target with ease.

   The first of its kind angiographic RCT enrolled 114 patients with a

head-to-head comparison between paclitaxel and sirolimus in small vessels

(≤2.75 mm), de-novo coronary artery lesions. Patients were randomized in

a 1:1 fashion between Magic Touch

(https://www.conceptmedical.com/product/magic-touch/) (Concept Medical) or

SeQuent Please Neo (B. Braun Melsungen AG). The RCT cruised under the

leadership of Co-chairs Prof. Patrick W. Serruys, Ireland and Dr. Bernardo

Cortese, Italy alongside PI Prof. Antonio Colombo, Italy.

    "45 years after the first balloon angioplasty, 36 years after the

introduction of stenting and 22 years after the first implantation of

bioresorbable scaffolds, the dream of 'leaving' nothing behind is still very

much alive in the mind of the interventional cardiologists if sub-acute

occlusion and late restenosis rates are competitive with permanently implanted

prosthesis.

    This trial, testing DCB in small vessels has (re)discovered the basic

mechanism of balloon angioplasty, beautifully documented by OCT prior to the

application of the drug coating and will provide a wealth of mechanistic

factors determining the angiographic and clinical outcomes of this treatment.

OCT with machine-learning will tell us what the impact is of tissue composition

and the prognostic significance of the 'therapeutic dissection', a ubiquitous

phenomenon after balloon angioplasty. I am more than ever excited and anxious

to see the angiographic results," Prof. Patrick Serruys (Co-chair) quoted.

    TRANSFORM 1 RCT is exploring the uncharted field of small vessels. The

primary objective of the study is to assess angiographic outcomes in respect to

the Net Gain (mm) at 6 months. Optical Coherence Tomography (OCT) was conducted

at baseline along with Quantitative Coronary Angiography (QCA) assessment which

was performed pre and post-procedure and at 6 months follow-up.

    "Small coronary vessels PCI should not be considered futile, in fact

prognostically they are important and associated with short and mid-term

adverse events, and DES is associated with double risk of TLF in this setting,

as compared to larger vessels. For the first time we will be able to see if

sirolimus, with its safety and wider therapeutic window, can match paclitaxel

as regards to its recognized lumen enlargement effects," quoting Co-chair Dr.

Bernardo Cortese, who is also the Chairman of the World's largest DCB

prospective registry EASTBOURNE.

    DCBs have long been used to treat in-stent restenosis (ISR) in CAD and have

been doing so fairly well and securing a place for themselves. Placing metal or

rather caging small vessels is something any physician would prefer avoiding

and so would the patient, considering the heavy metal load as well as the

future risk of re-narrowing due to ISR. DCBs can complement small vessels but

what is, and, was required, was a RCT. TRANSFORM 1 with its OCT and mechanistic

approach allowed the physician at targeting the lesion by measuring the precise

caliber of the vessel and then proceeding with the appropriately selected

diameter of the DCB to ensure full apposition to the vessel wall and effective

drug transfer. The documented Core Lab results (CORRIB Core Lab at NUI Galway,

Ireland) which are eagerly awaited, will surely provide a sound foundation for

the use of DCB in small vessels

    Dr. Sandeep Basavarajaiah, UK who has a wide experience with the Magic

Touch device, shares his opinion, "It's a great initiative by Concept Medical

(https://www.conceptmedical.com/) to sponsor such a detailed RCT, which will

have significant impact on the future of angioplasty especially when treating

small vessel de novo lesions. We are now slowly moving away from long layer of

stenting and evidence from such trials will further strengthen the belief among

cardiologists that 'less metal is better'. It's a bold step to embark on

comparing MagicTouch SCB (https://www.conceptmedical.com/product/magic-touch/)

with the widely used Paclitaxel coated balloon (SeQuent Please Neo) currently

available. Our unit (Heartlands Hospital) is one of the largest recruiting

sites for the trial and we have thoroughly enjoyed the experience and eagerly

looking forward to the results and taking part in future trials with MagicTouch"

    The results of TRANSFORM 1 will play a major role in deciding the future

treatment options in CAD treatment as they may imply the potential to widen the

use of DCB in more indications. Sirolimus coated balloons are already looked at

as a better option than paclitaxel in CAD and this study just might open a

fresher perspective for the community to move on from the contemporary DCB

application as well. Magic Touch SCB has already been granted breakthrough

device designation for ISR and Small Vessels, by the FDA and TRANSFORM 1 may

act as the best catalyst for its future potential.

    "The Transform 1 will give the needed angiographic follow-up about the

performance of Sirolimus eluting balloons versus Paclitaxel eluting balloons

evaluated in a scientific way. This type of information is a seminal

contribution in the field of Interventional Cardiology," said Prof. Antonio

Colombo, who has always been on the front when it comes to the usage of DCB in

present day PCI practice.

    About Magic Touch SCB:

    Magic Touch (https://www.conceptmedical.com/product/magic-touch/) is a CE

approved and commercially marketed Sirolimus coated balloon by Concept Medical,

developed using the proprietary Nanolute Technology. Magic Touch has been used

in >50,000 patients in major global markets. Nanoluté – the unique drug

delivery technology platform of Magic Touch balloon, is designed to deliver

sub-micron particles of Sirolimus which are then encapsulated in a

biocompatible drug carrier. The carrier-complex is designed to reach the

deepest layers of the vessel walls. The product is manufactured by Concept

Medical (https://www.conceptmedical.com/).

    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.

    www.conceptmedical.com

    Photo: https://mma.prnewswire.com/media/1897550/TRANSFORM_1_Enrollment.jpg

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

 SOURCE Concept Medical Inc.