Concept Medical’s Magic Touch DCB Evaluated in TRANSFORM II Trial

January 28, 2022—Concept Medical Inc. announced the commencement of the TRANSFORM II randomized controlled trial (RCT) of the company’s Magic Touch sirolimus-coated balloon.

Concept Medical noted that the first patient enrollment in the trial was reported by the Milan, Italy–based Fondazione Ricerca Ricerca e Innovazione Cardiovascolare, which is focused on cardiovascular research. The patient was treated on December 16, 2021, by Alessandro Sciahbasi, MD, at Sandro Pertini Hospital in Rome, Italy.

TRANSFORM II is an international, multicenter, prospective, investigator-driven, open-label RCT. The trial will observe and evaluate the efficacy of the Magic Touch sirolimus-coated balloon in a head-to-head comparison with an everolimus-eluting stent (EES) in 1:1 randomization in the native coronary vessels.

The TRANSFORM II RCT will enroll 1,325 patients aged > 18 years with clinical indication of a native vessel percutaneous coronary intervention eligibility (stable coronary artery disease or acute coronary syndrome). Native coronary artery lesions in a vessel with diameter > 2 mm and ≤ 3 mm and a maximum lesion length of 40 mm will be included with further randomization for intervention with Magic Touch or EES.

The trial’s primary endpoint is noninferiority in target lesion failure (a composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel myocardial infarction [MI]) at 12 months. As a coprimary endpoint, the trial will also verify and measure superiority of the study device in terms of net adverse clinical events (a composite of all-cause death, MI, ischemic stroke, and major bleeding [Bleeding Academic Research Consortium class 3 or 5]).

Follow-up will be conducted at 6 months and yearly for 5 years. An optical coherence tomography (OCT) substudy will be performed in a total of 70 patients, who will receive 9-month angio+OCT follow-up with core-lab analysis.

TRANSFORM II is led by Study Chairman Bernardo Cortese, MD, of the San Carlo Clinic in Paderno Dugnano-Milano, Italy. The trial steering committee includes Roxana Mehran, MD; Alexandre Abizaid, MD; Stefano Rigattieri, MD; Fernando Alfonso, MD; Jose Maria de la Torre Hernandez, MD; and Peter Smith, MD.

Dr. Cortese discussed the expectations of the trial and a drug-coated balloon (DCB) and drug-eluting stent (DES) in Concept Medical’s press release: “We do not need to expect a stent-like result when we use a DCB; what we aim to is to have similar results to DES and possibly an improved result on the long term, since we do not implant metal and metal from stents is associated with a small but continuous increase in adverse events year on year.”

He added, “Regarding DCB, at least when you use a reliable device, we have observed a flattening of the events curve after 18 months; so, why not expect better results after 3 to 4 years?”

TRANSFORM II will generate the data suggesting why this transition from stents to balloons is a necessity for some native coronary vessels, noted the company.

The company advised that the ongoing TRANSFORM I RCT, which has achieved > 50% enrollment, is comparing Concept Medical’s Magic Touch sirolimus DCB and SeQuent Please Neo paclitaxel DCB (B. Braun) in small coronary vessels.

In the United States, Magic Touch has received Breakthrough Device designation from the FDA for the treatment of small coronary vessels as well as in-stent restenosis.

In Europe, Magic Touch has European CE Mark approval and is commercially marketed by Concept Medical. It was developed using the proprietary Nanoluté Technology. Nanoluté is the drug delivery technology platform of the Magic Touch balloon. It is designed to deliver submicron particles of sirolimus that are then encapsulated in a biocompatible drug carrier. The carrier complex is designed to reach the deepest layers of the vessel walls, advised Concept Medical in the press release.