102 patients enrolled across 14 European centers to assess safety and clinical performance of 35 mm and 40 mm Freesolve™ Resorbable Magnesium Scaffolds in long coronary lesions
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the successful completion of patient enrollment in the BIOMAG™-LL Clinical Study, evaluating the safety and clinical performance of the Freesolve™ Resorbable Magnesium Scaffold (RMS) in 35 mm and 40 mm lengths for the treatment of de novo coronary lesions up to 38 mm. The study reflects Teleflex’s commitment to expanding clinical evidence supporting the use of the Freesolve™ RMS in percutaneous coronary intervention (PCI).
BIOMAG™-LL Clinical Study is a premarket, prospective, international, multi-center, single arm trial. The primary endpoint of the study is Target Lesion Failure* (TLF) rate at 12 months, a composite clinical endpoint commonly used to assess the safety and effectiveness of coronary interventional devices. Clinical follow-up is conducted at 1, 6, 12, 36, and 60 months post-procedure.
“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” said Prof. Flavio Ribichini, Interventional Cardiologist.† “The data generated by the BIOMAG™-LL Clinical Study will help determine whether longer Freesolve™ Scaffolds can expand treatment options for patients with longer lesions while supporting the broader evolution of resorbable scaffold therapy.”
The availability of longer scaffold lengths has the potential to provide physicians with additional treatment options for long lesions, reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons where temporary scaffolding is required to support the vessel wall.
“We are pleased to announce the successful completion of enrollment in the BIOMAG™-LL Clinical Study,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs at Teleflex. “The study represents an important step in expanding the Freesolve™ RMS portfolio to address longer coronary lesions while maintaining the performance characteristics of our resorbable magnesium scaffold technology.”
In addition, the 35 mm and 40 mm Freesolve™ Scaffold lengths are included in the ongoing BIOMAG™-III Pivotal Clinical Trial, which is currently enrolling patients in the United States and other international markets.
Long coronary lesions remain among the more challenging lesion subsets in PCI, often requiring multiple devices or overlapping implants to achieve complete lesion coverage. Longer resorbable scaffold lengths may enable treatment of longer lesions with fewer implants, potentially simplifying procedures and reducing scaffold overlap. The BIOMAG™-LL Clinical Study is expected to provide important evidence regarding the use of 35 mm and 40 mm Freesolve™ Scaffolds in lesions up to 38 mm. The data could support broader treatment options for patients with diffuse coronary artery disease, further advancing the clinical application of resorbable magnesium scaffold technology.
Expanding the Freesolve™ RMS Size Matrix
The 35 mm and 40 mm scaffold lengths evaluated in BIOMAG™-LL Clinical Study are designed to complement the current Freesolve™ RMS size matrix, which offers diameters of 2.5 mm, 3.0 mm, 3.5 mm and 4.0 mm, and lengths of 13 mm, 18 mm, 22 mm, 26 mm and 30 mm. Freesolve™ RSM is commercially available in CE-mark accepting countries only.
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.
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. Please contact your local representative © 2026 Teleflex Incorporated. All rights reserved. MC-012466 Rev 0. Revised 10/2026.
* Target Lesion Failure (TLF) is a standard composite measure of device safety and effectiveness that includes cardiac death, Target Vessel Q-wave or non-Q wave Myocardial Infarction, and clinically-driven target lesion revascularization.
†Prof. Flavio Ribichini is a paid consultant of Teleflex.
CAUTION—Investigational device. Limited by the United States law to investigational use.
Freesolve™ RMS is not approved for sale in the United States and is commercially available in CE-mark accepting countries only. Indications for Use may vary by geographic location.
Freesolve™ RMS is clinically often referred to as DREAMS 3G RMS.
Contacts
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836
