{"id":1012435,"date":"2026-10-22T06:48:28","date_gmt":"2026-10-22T10:48:28","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/teleflex-announces-fda-breakthrough-device-designation-for-freesolve-resorbable-magnesium-scaffold\/"},"modified":"2026-10-22T06:48:28","modified_gmt":"2026-10-22T10:48:28","slug":"teleflex-announces-fda-breakthrough-device-designation-for-freesolve-resorbable-magnesium-scaffold","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/teleflex-announces-fda-breakthrough-device-designation-for-freesolve-resorbable-magnesium-scaffold\/","title":{"rendered":"Teleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold"},"content":{"rendered":"

<\/p>\n

Teleflex Announces FDA Breakthrough Device Designation for <\/b>Freesolve\u2122 Resorbable Magnesium Scaffold<\/b><\/p>\n

WAYNE, Pa.–(BUSINESS WIRE<\/a>)–
\nTeleflex 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\u2122 Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI).<\/p>\n

\nTo 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.<\/p>\n

\n\u201cBreakthrough Device Designation represents a significant milestone towards bringing Freesolve\u2122 RMS technology to U.S. physicians and their patients,\u201d said Dr. David E. Kandzari\u2020<\/sup>, U.S. National Principal Investigator for the BIOMAG\u2122-III Pivotal Trial, Chief, Piedmont Heart Institute, and Chief Scientific Officer, Piedmont Healthcare in Atlanta, Georgia, USA. \u201cThis designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention.\u201d<\/p>\n

\nFreesolve\u2122 RMS utilizes the proprietary BIOmag\u2122 Magnesium Alloy and BIOlute\u2122 Bioabsorbable Coating Technology, providing vessel support during and after implantation.1,2<\/sup> At 12 months, 99% of the magnesium is resorbed.3<\/sup><\/p>\n

\nFreesolve\u2122 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\u2122 RMS has already shown positive long-term outcomes in the BIOMAG\u2122-I First-In-Human (FIH) Study (NCT04157153<\/a>), demonstrating a 3.5% target lesion failure (TLF)*<\/sup> rate at four years and no new clinical events between two and four years.4<\/sup><\/p>\n

\n\u201cAt Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation,” said Jason Fontana, President and General Manager of Interventional at Teleflex. \u201cThis designation marks an important milestone in our efforts to bring Freesolve\u2122 RMS to patients in the United States. Building on the FDA\u2019s previous Breakthrough Device Designation for Freesolve\u2122 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\u2122 RMS has the potential to redefine clinical practice in today\u2019s cath labs.\u201d<\/p>\n

\nTogether with the ongoing BIOMAG\u2122-III Pivotal Trial (NCT07258290)<\/a>, designed to support a future U.S. FDA Premarket Approval (PMA) application, the designation may support the future commercial availability of Freesolve\u2122 RMS in the United States. Freesolve\u2122 RMS is currently CE Marked and commercially available in numerous countries across Europe, Asia-Pacific, South America and the Middle East. Freesolve\u2122 Below-The-Knee (BTK) RMS was previously granted BDD in 2024 for the treatment of chronic limb-threatening ischemia (CLTI).<\/p>\n

About Teleflex Incorporated
\n
<\/b>As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people\u2019s 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.<\/p>\n

\nTeleflex is the home of Arrow\u2122, Barrigel\u2122, Deknatel\u2122, LMA\u2122, Pilling\u2122, QuikClot\u2122, R\u00fcsch\u2122, UroLift\u2122 and Weck\u2122 \u2013 trusted brands united by a common sense of purpose.<\/p>\n

\nAt Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com<\/a>.<\/p>\n

Forward-Looking Statements
\n
<\/b>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.<\/p>\n

\nCAUTION\u2014Investigational device. Limited by the United States law to investigational use.<\/p>\n

\nFreesolve\u2122 RMS is clinically often referred to as DREAMS 3G RMS.
\n
Freesolve\u2122 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.<\/p>\n

\nFreesolve\u2122 BTK RMS is not approved for sale in the United States.<\/p>\n

Teleflex, the Teleflex logo, Arrow, Barrigel, BIOlute, BIOmag, Deknatel, Freesolve, LMA, Pilling, QuikClot, R\u00fcsch, 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.<\/i><\/p>\n

\u00a9 2026 Teleflex Incorporated. All rights reserved. MC-012515 Rev 0. Revised 10\/2026.<\/i><\/p>\n

References<\/b><\/p>\n

    \n
  1. \nSeguchi 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.<\/p>\n<\/li>\n
  2. \nTeleflex data on file.<\/p>\n<\/li>\n
  3. \nSeguchi 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<\/a>. Research sponsored by Teleflex.<\/p>\n<\/li>\n
  4. \nTorzewski, 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<\/a>. Research sponsored by Teleflex.<\/p>\n<\/li>\n<\/ol>\n

    \n*For BIOMAG\u2122-I Study, TLF is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. BIOMAG\u2122-I FIH Study data is based on Kaplan-Meier failure estimate analysis.<\/p>\n

    \u2020<\/sup>Dr. Kandzari is a paid consultant of Teleflex.<\/p>\n

    \"\"<\/p>\n

    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20261022623099\/en\/<\/a><\/span><\/p>\n

    \nTeleflex
    \n
    Lawrence Keusch
    \n
    Vice President, Investor Relations and Strategy Development
    \n
    investor.relations@teleflex.com
    \n<\/a>
    610-948-2836<\/p>\n

    KEYWORDS:<\/b> Pennsylvania United States North America<\/p>\n

    INDUSTRY KEYWORDS:<\/b> FDA Surgery Medical Devices Health Cardiology<\/p>\n

    MEDIA:<\/b><\/p>\n\n\n\n\n
    Logo<\/b><\/font><\/td>\n<\/tr>\n
    \"Logo\"<\/td>\n<\/tr>\n
    <\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Teleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold 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\u2122 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. \u201cBreakthrough Device Designation represents a significant milestone … <\/p>\n

    Continue reading “Teleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1012435","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nTeleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/teleflex-announces-fda-breakthrough-device-designation-for-freesolve-resorbable-magnesium-scaffold\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Teleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Teleflex Announces FDA Breakthrough Device Designation for Freesolve\u2122 Resorbable Magnesium Scaffold 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\u2122 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. 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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. 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