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 on September 1, 2020 in 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".
www.conceptmedical.com
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The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company's Sirolimus coated balloon. The Company has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee