Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold

Four-year first-in-human study results showed a 3.5% target lesion failure rate and no new clinical events between years two and four.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

WAYNE, Pa.--(BUSINESS WIRE)-- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI).

To qualify for a BDD, device technology must address an unmet clinical need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review.

“Breakthrough Device Designation represents a significant milestone towards bringing Freesolve™ RMS technology to U.S. physicians and their patients,” said Dr. David E. Kandzari^†, U.S. National Principal Investigator for the BIOMAG™-III Pivotal Trial, Chief, Piedmont Heart Institute, and Chief Scientific Officer, Piedmont Healthcare in Atlanta, Georgia, USA. “This designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention.”

Freesolve™ RMS utilizes the proprietary BIOmag™ Magnesium Alloy and BIOlute™ Bioabsorbable Coating Technology, providing vessel support during and after implantation.^1,2 At 12 months, 99% of the magnesium is resorbed.³

Freesolve™ RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons in cases where temporary scaffolding is required to support the vessel wall. Freesolve™ RMS has already shown positive long-term outcomes in the BIOMAG™-I First-In-Human (FIH) Study (NCT04157153), demonstrating a 3.5% target lesion failure (TLF)^* rate at four years and no new clinical events between two and four years.⁴

“At Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation," said Jason Fontana, President and General Manager of Interventional at Teleflex. “This designation marks an important milestone in our efforts to bring Freesolve™ RMS to patients in the United States. Building on the FDA’s previous Breakthrough Device Designation for Freesolve™ RMS in below-the-knee applications, it further underscores the potential of bioresorbable magnesium scaffold technology and our commitment to a leave-nothing-behind approach. Freesolve™ RMS has the potential to redefine clinical practice in today’s cath labs.”

Together with the ongoing BIOMAG™-III Pivotal Trial (NCT07258290), designed to support a future U.S. FDA Premarket Approval (PMA) application, the designation may support the future commercial availability of Freesolve™ RMS in the United States. Freesolve™ RMS is currently CE Marked and commercially available in numerous countries across Europe, Asia-Pacific, South America and the Middle East. Freesolve™ Below-The-Knee (BTK) RMS was previously granted BDD in 2024 for the treatment of chronic limb-threatening ischemia (CLTI).

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™ RMS is clinically often referred to as DREAMS 3G RMS.
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™ BTK RMS is not approved for sale in the United States.

Teleflex, the Teleflex logo, Arrow, Barrigel, BIOlute, 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.

© 2026 Teleflex Incorporated. All rights reserved. MC-012515 Rev 0. Revised 10/2026.

References

1. Seguchi M, Baumann-Zumstein P, Fubel A, et al. Preclinical evaluation of the degradation kinetics of third generation resorbable magnesium scaffolds. Eurointervention; 2023; 19: e167-e175. DOI: 10.4244/EIJ-D-22-00718. Research sponsored by Teleflex.
2. Teleflex data on file.
3. Seguchi M, Aytekin A, Xhepa E, et al. Twelve-months vessel healing profile following the novel resorbable magnesium scaffold implantation: an intravascular OCT analysis of the BIOMAG-I trial. Eur Heart J; 2023; 44(S2), ehad655.2180, https://doi.org/10.1093/eurheartj/ehad655.2180. Research sponsored by Teleflex.
4. 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. 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. Research sponsored by Teleflex.

*For BIOMAG™-I Study, 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.

^†Dr. Kandzari is a paid consultant of Teleflex.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261022623099/en/

Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

Source: Teleflex Incorporated

Key Terms

breakthrough device designation regulatory

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

percutaneous coronary intervention medical

A minimally invasive heart procedure that opens narrowed or blocked coronary arteries by threading a thin tube from a wrist or groin to the heart and using a balloon and usually a small metal scaffold (stent) to restore blood flow. Investors care because the procedure drives sales and regulatory exposure for device makers, hospitals and suppliers, and influences healthcare costs and insurance payments—think of it like a plumbing repair that requires parts, skilled labor and follow-up maintenance.

target lesion failure medical

Target lesion failure is a clinical-trial outcome that measures whether a specific treated segment of a blood vessel causes serious problems after an intervention — typically defined as death related to the heart, a heart attack in the treated area, or the need for another procedure on that same spot. For investors it’s a compact gauge of a device or treatment’s effectiveness and safety, like a warranty score for a repaired pipe: fewer failures suggest better performance, faster regulatory approval, stronger sales and lower long-term costs.

premarket approval regulatory

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.