September 14, 2020 — Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrollment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch 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 the 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 of Italy.
The index patient was enrolled at Maria Cecilia Hospital, Cotignola, Italy, and went through a successful PCI procedure on September 1, 2020, in Italy, under the care of PI Prof. Antonio Colombo.
To quote Antonio Colombo on the index patient enrollment, “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, remarked, “This is great news. We struggled in the last couple of years to have a modern and scientific study design that includes OCT for lesion assessment. We look forward to enrolling all the patients at the earliest opportunity by this remarkable group of investigators.”
Patrick Serruys, Professor of Interventional Medicine & Innovation, National University of Ireland, Galway, said, “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 caliber of the vessel was not carefully documented as we will do with the use of OCT in the TRANSFORM-1 study, analyzed in the CORRIB Core Lab at the National University of Ireland (NUI Galway) under the leadership of Prof. Yoshi Onuma.”
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.