Hotline release-T1 on the go

“Well Begun!!! … Index patient enrolled in the crucial Transform -1 RCT using MagicTouch sirolimus coated balloon for small coronary vessels”.

Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FORMagicTouch sirolimus coated balloon).

TRANSFORM-1 is a prospective, randomized, multi-center, European study focusing on coronary artery lesions in small vessels with a head-on comparison between sirolimus coated MagicTouch and paclitaxel coated SeQuent Please NEO of B. Braun. 114 patients are planned to be randomized 1:1 for Magic Touch or SeQuent Please NEO.

The primary objective of the study is to compare angiographic outcomes of MagicTouch sirolimus coated balloon with SeQuent Please NEO, for the treatment of de-novo coronary artery lesions in small vessels (≤2.5 mm) with respect to Net Gain (mm) at 6 months follow-up. Optical Coherence Tomography (OCT) will be conducted at baseline. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at 6 months follow-up. Quantitative OCT assessment will be performed at baseline. Clinical follow-up will occur at 1, 6 and 12 months post-PCI.

The study is chaired by Prof. Patrick Serruys, Ireland and Dr. Bernardo Cortese, Italy and the principal investigator is Prof. Antonio Colombo from Italy.

The index patient was enrolled at Maria Cecilia Hospital, Cotignola, Italy and went through successful PCI procedure onSeptember 1, 2020in Italy under the care of PI Prof. Antonio Colombo.

To quote Antonio Colombo on the index patient enrolment, “Transform-1 is launching a new standard in Drug Coated Balloon technology; let us enthusiastically make this study move forward.”.

Bernardo Cortese, the Chairman of the study was equally elated and remarked, “This is great news. We struggled in the last couple of years to have one of the most modern and scientific study design that includes OCT for lesion assessment. We look forward to enrolling all the patients at the earliest by this remarkable group of Investigators.”

Patrick Serruys, Professor of Interventional Medicine & Innovation, National University of Ireland, Galway was all praise, “I have to give full credit to Concept Medical and its CEO Manish Doshi for allowing key opinion leaders like Bernardo Cortese, and Antonio Colombo to perform an important mechanistic study based on OCT to diagnose truly small vessels and to attempt to demonstrate in a randomized trial the superior value of the Magic Touch SCB, a DCB technology that uses the powerful hydrophilic sirolimus encapsulated in lipidic microsphere with a deep vessel wall penetration and a long intra parietal residency. Many studies on small vessels are in fact misnomers since the precise calibre of the vessel was not carefully documented like we will do with the use of OCT in the TRANSFORM 1 study analysed in the CORRIB Core Lab at the National University of Ireland (NUI Galway) under the leadership of Prof. Yoshi Onuma”.

About MagicTouch:

MagicTouch is a CE approved and commercially marketed Sirolimus coated balloon, developed using proprietary Nanolute Technology. MagicTouch has been deployed in >50,000 patients in major global markets. Nanolute – the unique drug delivery technology platform of MagicTouch 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.

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.

I am proud to inform that FASICO NATIVES has been accepted for publication in the Journal of Cardiovascular Medicine.

After FASICO and NANOLUTE’ this is a crucial piece for the assessment of the safety and efficacy of Magic Touch sirolimus-eluting DCB. In this study, which will be available soon for the readers, we have conducted a core-lab assessment of the angiographic outcome of SCB for native coronary vessel disease. 

With more than one third of patients showing late lumen enlargement (just like the top-in-class paclitaxel DCB), the average LLL was 0.09mm in this cohort of consecutive small-vessel-disease patients.

Core lab analysis was performed by Cardialysis (Rotterdam, NL).

…waiting for the interim analysis of the EASTBOURNE study, 1043 patients, to be presented at EuroPCR 2019 as late breaking clinical trial!

Recently, a meta-analysis by Katsanos et a. showed an increase in late mortality after paclitaxel administration (either with DES or DCB) in the peripheral field (SFA).

The topic is hot and deserves a deep analysis of the available data. For the moment, our position regarding DCB is that the technology, if used in expert hands and following the available position papers, is safe and effective for the treatment of lower extremity disease.

Please, take a look at the recently published editorial of F Fanelli, T Zeller and myself in the Journal of Endovascular therapy.

The DCB book is on the go…

Fernando Alfonso, MD, head of Cardiology at Hospital La Princesa in Madrid, just confirmed that his center is ready to enroll patients at PICCOLETO II, that thereafter today becomes international!

The scientific validity of the RCT study PICCOLETO II,  EES vs. Elutax SV for the treatment of small coronary arteries, is confirmed by the patronage recently obtained by the Italian Scientific Society of Interventional Cardiology GISE.patrocinio-studio-non-profit-2016

Great news-a few days ago I had the chance to use a sirolimus-coated balloon for coronary PCI in the first european patient (to say the truth, the first patient of the western world)!!

This very promising device just obtained the CE Mark for this application. A long way is ahead and I am really excited to be part of this adventure in designing a strict scientific program on the matter. In fact, no one wants to repeat the mistakes of the paclitaxel-eluting technology, that has only now reached a reliable scientific background.

A couple of weeks ago, I had the pleasure to be invited at the CLIC, a cardiovascular meeting organized by Dr Amico in Caltanissetta. The event had the scientific background of some renown physicians from the group of Prof Tamburino in Catania, and I had the pleasure to be the only “continental” physician invited!

The meeting was of high scientific level and the discussion was interactive and interesting.

I contributed with a speech entitled “Incomplete revascularization and drug-coated balloons”, a setting where DCB may have a specific role. I also gave some contributions regarding biovascular scaffolds during the discussion. Give a look at the nice pics.

A few weeks ago, our study on DCB in native coronary vessels left with a dissection was published in JACC Int, and we had the honor of receiving a dedicated Editorial from 2 experts on the field: R Byrne and M Joner. Their conclusion was different from ours from several points of view, so we deemed necessary to underline further aspects and we wrote a Letter to the Editor.