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Teleflex Receives FDA Breakthrough Device Designation for Freesolve

Teleflex announced that the U.S. FDA has granted Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention. 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.

Teleflex Completes Patient Enrollment in BIOMAG-LL Clinical Study

Teleflex Iannounced the successful completion of patient enrollment in the BIOMAG-LL Clinical Study, evaluating the safety and clinical performance of the Freesolve Resorbable Magnesium Scaffold 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. BIOMAG-LL Clinical Study is a premarket, prospective, international, multi-center, single arm trial. The primary endpoint of the study is Target Lesion Failure 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.

Teleflex Study Shows Arrowg+ard Technology Reduces CLABSI Risk by 70%

Teleflex announced the publication of its latest peer-reviewed study in the American Journal of Infection Control demonstrating that Central Venous Catheters, or CVCs, protected with Arrowg+ard Technology were associated with a statistically significant 70% lower hazard of central line-associated bloodstream infections, or CLABSIs, compared with plain, non-impregnated catheters during a 30-day period. CLABSI is a serious healthcare-associated infection, increasing patient risk, length of stay and morbidity, and increased healthcare costs. In this multinational study of 1,750 critically ill patients in four countries, patients receiving CVCs protected with Arrowg+ard Technology experienced a 70% lower risk of CLABSI during the 30-day period than patients receiving plain CVCs. The recently published study builds upon Teleflex's previously announced 2025 multinational prospective cohort study, which demonstrated a 70.5% reduction in overall CLABSI incidence among patients receiving Arrowg+ard Blue or Arrowg+ard Blue Plus CVCs vs. plain CVCs. Together, these complementary studies provide evidence of both reduced overall infection burden and reduction in infection risk over time.