Late-breaking results presented at TCT 2026 show an implant-free strategy with MagicTouch Sirolimus Coated Balloon is non-inferior to everolimus-eluting stents in de novo coronary artery disease
Tampa, Florida, November 1, 2026 – Sirolimus-coated balloon (SCB) strategy was non-inferior to contemporary everolimus-eluting stents (EES) for Target Lesion Failure (TLF) at 12 months in patients with de novo coronary artery disease. These are the results of the TRANSFORM II randomised trial, presented today as a Late-Breaking Clinical Trial at TCT 2026 and accepted in The Lancet. The trial evaluated the MagicTouch Sirolimus Coated Balloon, developed by Concept Medical.
TRANSFORM II is an investigator-initiated, open-label, non-inferiority trial. It enrolled 1,842 patients in 53 centres in 11 countries across Europe, Asia and South America. Patients with a de novo native coronary lesion (vessel diameter 2.0 to 3.5 mm, lesion length ≤50 mm) were randomised 1:1 to the MagicTouch SCB, with bailout stenting if needed, or to EES implantation. Randomisation took place only after successful lesion preparation, as recommended by the Drug-Coated Balloon Academic Research Consortium. The population was highly complex; nearly half of patients presented with an acute coronary syndrome, more than a third had diabetes and about a third were at high bleeding risk.
At 12 months, TLF occurred in 2.1% of patients in the SCB group and 2.4% in the EES group (hazard ratio 0.86; 95% CI 0.47–1.59). Target Lesion Failure was defined as a composite of cardiac death, target-vessel myocardial infarction and ischaemia-driven target lesion revascularisation. The risk difference of −0.40 percentage points had a one-sided upper bound of 0.78 points, well below the prespecified 1.5 point margin (P=0.004 for non-inferiority). The result was consistent in the per-protocol and device-received analyses and across prespecified subgroups.
Bailout stenting was needed in only 7.6% of patients assigned to the SCB arm, much less often than in earlier large trials where randomisation came before lesion preparation. No definite or probable lesion thrombosis occurred in the SCB group, compared with 0.2% in the EES group. Net adverse clinical events, including bleedings, were numerically lower with SCB (4.1% vs 5.3%; HR 0.77; 95% CI 0.50–1.17), and rates of death, myocardial infarction, stroke and major bleeding were low and similar in both groups.
Any target lesion revascularisation was more frequent with SCB (2.5% vs 1.1%). However, ischaemia-driven revascularisation was similar in both groups (0.9% vs 0.8%).
“TRANSFORM II shows that when a lesion is well prepared, treating it with a sirolimus-coated balloon, without leaving a permanent metal implant, gives one-year clinical outcomes comparable to a modern drug-eluting stent,” said Bernardo Cortese, MD, Principal Investigator and Study Chair, Fondazione Ricerca e Innovazione Cardiovascolare, Milan. “Drug-coated balloon angioplasty should be seen as a strategy, not a simple device swap. Careful lesion preparation and readiness to stent when needed are central to its success.”
The investigators noted that event rates were lower than expected, that the results apply to lesions suitable for successful preparation and do not cover severely calcified, left main, thrombotic or STEMI lesions, and that the centres taking part were experienced in drug-coated balloon PCI. Follow-up will continue to five years to find out whether avoiding a permanent implant reduces very late device-related events.
Leaving no permanent metal implant behind has long been a goal in coronary intervention, and TRANSFORM II adds randomised evidence to that discussion.
The trial was sponsored by Fondazione Ricerca e Innovazione Cardiovascolare ETS, Milan, Italy, with an unrestricted research grant from Concept Medical, which had no role in the trial’s design, analysis or reporting. ClinicalTrials.gov: NCT04893291.
Source: Data from TRANSFORM II, presented as a Late-Breaking Clinical Trial at the TCT USA Conference by Prof. Bernardo Cortese on November 01, 2026 and accepted in The Lancet.
MagicTouch is CE-marked. CAUTION: Investigational device in the United States, limited by Federal law to investigational use.
About Fondazione Ricerca e Innovazione Cardiovascolare
Fondazione RIC is an independent nonprofit foundation that supports investigator-driven cardiovascular research worldwide and is based in Italy and the United States. Founded in 2020, it supports the design and delivery of clinical trials. The foundation has designed and conducted 19 clinical trials, with 187 enrolling centers and more than 8,000 patients enrolled. More information is available at fondazioneric.org or by email at segreteria@fondazioneric.org.
About MagicTouch SCB
The MagicTouch SCB, developed by Concept Medical Inc., uses proprietary Nanoluté technology to deliver sub-micron particles of sirolimus encapsulated in a biocompatible carrier, designed to support penetration into the vessel wall. The device has received CE Mark approval in Europe and Breakthrough Device Designation from the U.S. FDA for the treatment of small coronary vessels and in-stent restenosis. MagicTouch has also received IDE approvals for in-stent restenosis and small vessel treatment, with trials ongoing for both indications.
About Concept Medical Inc.
Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through research and development of drug-delivery technologies. Its platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces. The company developed the MagicTouch family of Sirolimus-Coated Balloons (SCB), the world’s first SCB technology, which are used in coronary and peripheral artery disease. The MagicTouch and Abluminus product lines have been used in the treatment of more than a million patients globally.
For more information, visit www.conceptmedical.com. For media inquiries, contact pr@conceptmedical.com.
Disclaimer: This article is provided for general informational and educational purposes only and does not constitute medical advice, diagnosis, treatment recommendations, or an endorsement of any medical device, procedure, or treatment strategy. Coronary artery disease and other cardiovascular conditions require individualized evaluation and management by qualified healthcare professionals. Clinical trial results may apply only to the patient populations, devices, procedures, and study conditions described, and individual outcomes may vary. Readers should not interpret the information presented as evidence that any particular treatment is appropriate for their condition or as a substitute for consultation with a qualified cardiologist or other healthcare professional. The safety, effectiveness, regulatory status, and approved uses of medical devices may vary by country and indication. Any statements regarding investigational devices or treatments should not be understood as an indication that such products are approved for routine clinical use. Always consult an appropriate healthcare professional regarding diagnosis, treatment options, risks, and benefits.
