Four‑Year BIOMAG™-I Study Results Presented at EuroPCR Confirm Long‑Term Safety and Sustained Performance of the Freesolve™ Resorbable Magnesium Scaffold (DREAMS 3G)
Persistently Low Target Lesion Failure and No New Cardiac-Related Event
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the four‑year follow‑up data from the First-in-Human BIOMAG™-I Clinical Study (NCT04157153)* presented at the EuroPCR conference in Paris, France by Prof. Jan Torzewski (Klinikverbund Allgäu, Germany).
Conducted exclusively across European centers and enrolling 116 patients, the study continues to demonstrate a favorable long‑term safety profile1, with no new cardiac‑related1 events observed between two and four years follow‑up period, establishing the third-generation Freesolve™ Resorbable Magnesium Scaffold (RMS) as a valuable treatment option.
Prof. Torzewski presented the results during the session "Lessons from the long‑term DES data: how can they inform today's practice," highlighting the relevance of long‑term ‘leave nothing behind' approach with novel technologies in modern interventional cardiology.
Importantly, no cardiac death1, no target-vessel myocardial infarction (TV-MI)1, and no definite or probable scaffold thrombosis1 have been observed through four years1. The target lesion failure (TLF**) rate was 3.5%1, impelled by the clinically-driven-target lesion revascularization (CD-TLR)1, of which only one event occurred beyond the resorption period of the scaffold (at 1-year)2. These findings reinforce the safety profile3, and sustained device performance3 of the Freesolve™ RMS.
"These long‑term BIOMAG™-I First-In-Human Study data continue to support the safety and performance of the Freesolve™ Scaffold," said Prof. Michael Haudeǂ, Principal Investigator of the BIOMAG™-I Study. "The absence of cardiac death, target‑vessel MI, or scaffold thrombosis throughout four years, combined with the very low TLF rate, is highly promising and aligns with the vascular healing response we aim to achieve with bioresorbable technologies."
A Promising Path Toward Future Randomized Evidence
The continuing favorable 4‑year outcomes further support the potential of this resorbable scaffold as a viable treatment option, offering temporary mechanical support while maintaining excellent long‑term safety and efficacy.
"Our focus is on enabling durable clinical outcomes, so we're delighted to see this plateau of events continuing out to 4 years," said Prof. Dr. Georg Nollert, Vice President Medical Affairs at Teleflex. "This gives us even more confidence that RMS could be a valuable option for treating patients where the aim is to avoid a permanent implant."
These results provide a strong foundation for the ongoing BIOMAG™‑II and pending BIOMAG™‑III Randomized Controlled Trials, both of which will be critical in demonstrating Freesolve™ RMS as a competitive alternative to contemporary drug‑eluting stents (DES).
Bioresorbable scaffolds have been developed to provide temporary mechanical support, and to prevent long-term stent-related adverse events3. Freesolve™ RMS is made of the proprietary BIOmag™ Magnesium Alloy and maintains a resorption time of 12 months4.
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
CAUTION—Investigational device. Limited by the United States law to investigational use.
Freesolve is clinically often referred to as DREAMS 3G.
Freesolve™ RMS is not for sale in the United States and is commercially available in CE-mark accepting countries only. Indications for Use may vary by geographic location.
References
- Torzewski, J. Lessons from the long-term DES data: how they can inform today's practice - BIOMAG-I: 4-Year Clinical Outcomes of the Resorbable Magnesium Scaffold-DREAMS 3G. pcronline.com Published May 20, 2026. Accessed June 3, 2026. https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2026/EuroPCR/Lessons-from-the-long-term-DES-data-how-they-can-inform-today-s-practice?auth=true. Research sponsored by Teleflex.
- Seguchi M. Twelve-months vessel healing profile following the novel resorbable magnesium scaffold implantation: an intravascular OCT analysis of the BIOMAG-I trial. esc365.escardio.org. Published August 27, 2023. Accessed June 3, 2026. https://esc365.escardio.org/presentation/269109. Research sponsored by Teleflex.
- Haude M. ǂ, Wlodarczak A, van der Schaaf, RJ, et al. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023; 59:101940. doi: 10.1016/j.eclinm.2023.101940. Research sponsored by Teleflex.
- Scaffold resorbs 99.3% at 12 months (markers are not resorbable), Teleflex Data on file.
* BIOMAG™-I FIH Trial, ClinicalTrials.gov: NCT04157156 https://clinicaltrials.gov/study/NCT04157153?term=BIOMAG&viewType=Card&rank=2
**Target Lesion Failure (TLF) is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. BIOMAG™-I FIH Study data is based on Kaplan-Meier failure estimate analysis.
ǂ Prof. Michael Haude is a paid consultant of Teleflex.
Teleflex, the Teleflex logo, Arrow, Barrigel, BIOMAG, Deknatel, Freesolve, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries.
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Lawrence Keusch
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