BIOMAG™-LL Study Completes Enrollment for Longer Freesolve™ Magnesium Scaffolds
Teleflex Incorporated (NYSE: TFX), a global provider of medical technologies, has announced the successful completion of patient enrollment in the BIOMAG™-LL Clinical Study, which is evaluating the safety and clinical performance of longer Freesolve™ Resorbable Magnesium Scaffolds (RMS) for the treatment of de novo coronary artery lesions. The study is designed to assess 35 mm and 40 mm scaffold lengths in lesions measuring up to 38 mm, addressing an important clinical need in the treatment of patients with long or diffuse coronary artery disease.
The completion of enrollment marks a significant milestone in Teleflex’s efforts to expand the clinical evidence supporting Freesolve™ RMS technology in percutaneous coronary intervention (PCI). By evaluating longer scaffold lengths, the study aims to determine whether these devices can provide physicians with additional treatment options for patients whose coronary lesions require extended coverage.
BIOMAG™-LL is a prospective, international, multicentre, single-arm, premarket clinical trial. Its primary endpoint is the rate of target lesion failure (TLF) at 12 months, a composite clinical measure commonly used to assess the safety and effectiveness of coronary interventional devices. Patients will undergo clinical follow-up at 1, 6, 12, 36 and 60 months after the procedure, enabling investigators to assess outcomes over both the short and longer term.
The study forms part of Teleflex’s broader clinical development programme for Freesolve™ RMS and complements the ongoing BIOMAG™-III Pivotal Clinical Trial, which is also evaluating the 35 mm and 40 mm scaffold lengths and is currently enrolling patients in the United States and other international markets.
Addressing the Challenges of Long Coronary Lesions
Long coronary lesions represent a challenging subset of patients undergoing PCI, a minimally invasive procedure used to restore blood flow through narrowed or blocked coronary arteries. These lesions may extend over substantial portions of a coronary artery and can be associated with diffuse coronary artery disease, in which atherosclerotic changes affect longer arterial segments rather than a single, localised area.
Treating long lesions can require physicians to use multiple devices or overlapping implants to achieve adequate coverage. Although conventional permanent stents can provide structural support to keep a vessel open, the use of multiple or overlapping stents can increase the length of the artery containing permanent metallic implants.
Consequently, physicians continue to evaluate treatment approaches that may provide the necessary vessel support while reducing the extent of permanent implanted material where clinically appropriate.
Resorbable scaffold technologies are being developed to address this consideration. Unlike conventional permanent metallic stents, resorbable scaffolds are designed to provide temporary structural support before the scaffold material gradually breaks down and is absorbed by the body.
The Freesolve™ Resorbable Magnesium Scaffold uses magnesium-based technology and is intended for coronary intervention. The BIOMAG™-LL Clinical Study is investigating whether longer versions of the scaffold can expand its application to patients with more extensive coronary lesions.
The availability of 35 mm and 40 mm scaffold lengths could give interventional cardiologists additional options when treating lesions that require longer coverage. If supported by clinical evidence and applicable regulatory approvals, longer devices could potentially reduce the need for multiple implants in selected patients.
However, the clinical benefits and safety of these longer lengths will need to be established through the study’s planned evaluations. The successful completion of enrollment represents progress in generating that evidence, rather than confirmation of clinical superiority or improved patient outcomes.
Clinical Study to Evaluate Safety and Performance
The BIOMAG™-LL Clinical Study has been designed to investigate the use of 35 mm and 40 mm Freesolve™ RMS devices in patients with de novo coronary lesions measuring up to 38 mm.
A de novo lesion refers to a newly treated lesion rather than one that has previously undergone treatment. The study’s focus on these lesions is relevant to patients requiring PCI for coronary artery narrowing where physicians need to restore vessel patency and provide appropriate structural support.
The trial uses a prospective, international, multicentre, single-arm design. In a prospective study, patient outcomes are collected after enrollment according to a predefined protocol. A multicentre approach enables investigators at multiple clinical sites to contribute data, while the international scope supports evaluation across participating centres in different markets.
Because BIOMAG™-LL is a single-arm study, participants receive the investigational treatment without a separate randomised comparison group within the trial. Its findings will therefore need to be interpreted in the context of the study design, patient population, clinical endpoints and available supporting evidence.
The primary endpoint is target lesion failure at 12 months. TLF is a composite endpoint used in coronary device studies to capture clinically important adverse outcomes associated with the treated lesion. Depending on the study protocol, such composite measures commonly include cardiac death, myocardial infarction related to the target vessel, and clinically driven repeat revascularisation of the target lesion.
The specific endpoint definitions and criteria established in the BIOMAG™-LL protocol will determine how events are assessed and reported.
The trial’s follow-up schedule includes assessments at 1, 6, 12, 36 and 60 months after the procedure. This schedule will allow investigators to examine early clinical outcomes and collect longer-term data as follow-up progresses.
The 12-month primary endpoint will provide the principal assessment specified for the study, while the additional follow-up periods may contribute information about longer-term clinical performance and safety. Such extended observation is particularly relevant for resorbable technologies, which are intended to provide temporary support rather than remain permanently implanted.
Longer Scaffolds May Expand Treatment Options
Prof. Flavio Ribichini, an interventional cardiologist, highlighted the clinical rationale for investigating longer resorbable scaffolds in patients with diffuse coronary artery disease.
“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” Prof. Ribichini said. “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.”
His comments reflect an ongoing clinical interest in approaches that can provide appropriate support to the coronary artery while potentially limiting the length of permanent implanted material.
In patients with long lesions, physicians must select devices based on several factors, including lesion anatomy, vessel diameter, disease distribution and the need for adequate lesion coverage. In some cases, multiple stents may be required to treat an extended segment of disease.
Longer resorbable scaffolds could potentially reduce the need for overlapping devices in selected cases. Fewer implants might simplify some procedures and reduce the amount of scaffold overlap, although the actual clinical implications will depend on lesion characteristics, device performance and procedural considerations.
The study is also relevant to the broader treatment landscape for coronary artery disease, where drug-coated balloons provide another option for selected lesions. Drug-coated balloons deliver an antiproliferative drug to the vessel wall without leaving a permanent metallic implant behind. Unlike stents or scaffolds, however, they do not provide the same sustained mechanical support to the vessel.
Longer resorbable scaffolds may therefore offer an additional approach in cases where temporary structural support is considered necessary. Their potential role relative to drug-coated balloons and conventional stents will depend on the clinical situation and the evidence available to guide treatment selection.
BIOMAG™-LL is intended to generate data that will help determine how the longer Freesolve™ devices perform in the specific population being studied.
Teleflex Highlights Progress in the Freesolve™ RMS Programme
Prof. Dr. Georg Nollert, Vice President of Medical Affairs at Teleflex, described the completion of enrollment as an important development in the company’s efforts to expand the Freesolve™ RMS portfolio.
“We are pleased to announce the successful completion of enrollment in the BIOMAG™-LL Clinical Study,” Prof. Dr. Nollert said. “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.”
The statement highlights Teleflex’s focus on extending the range of scaffold sizes available for clinical investigation. Expanding the size matrix may allow the technology to be evaluated across a broader range of coronary lesion lengths and vessel dimensions.
Nevertheless, the availability of additional device sizes does not, by itself, establish that longer scaffolds will improve clinical outcomes. Evidence from the ongoing clinical programme will be important in determining the safety, performance and appropriate use of these devices.
The company is pursuing evidence generation through both BIOMAG™-LL and BIOMAG™-III. The two studies include the 35 mm and 40 mm Freesolve™ scaffold lengths, providing complementary components of the clinical development programme.
BIOMAG™-III Pivotal Trial Continues Enrollment
In addition to BIOMAG™-LL, Teleflex is conducting the BIOMAG™-III Pivotal Clinical Trial, which is currently enrolling patients in the United States and other international markets.
The inclusion of the 35 mm and 40 mm scaffold lengths in this pivotal trial is an important part of the company’s broader evaluation of the devices. Pivotal clinical studies are designed to generate evidence supporting regulatory assessment and the potential use of medical technologies in their intended populations.
The ongoing enrollment in BIOMAG™-III indicates that the clinical evaluation of longer Freesolve™ scaffolds is continuing beyond the BIOMAG™-LL enrollment milestone.
The results from these studies may help clarify the role of longer magnesium-based resorbable scaffolds in coronary intervention. Key considerations will include the frequency of target lesion failure, adverse events, the durability of clinical outcomes and the performance of the devices across the populations studied.
The studies will also contribute to the evidence required to evaluate whether longer scaffold lengths can be incorporated into treatment strategies for patients with extensive coronary lesions.
Expanding the Freesolve™ RMS Size Matrix
The 35 mm and 40 mm lengths being investigated in BIOMAG™-LL are designed to complement the existing Freesolve™ RMS size matrix.
The current portfolio includes four scaffold diameters: 2.5 mm, 3.0 mm, 3.5 mm and 4.0 mm. Available lengths in the existing matrix are 13 mm, 18 mm, 22 mm, 26 mm and 30 mm.
The addition of the longer lengths under clinical evaluation would extend the range of options being studied for patients who require treatment across longer coronary lesions.
Having a range of scaffold diameters and lengths is important in PCI because coronary arteries vary in size, and lesions differ in both length and anatomical complexity. Physicians must select devices that appropriately match the treated vessel and provide the necessary lesion coverage.
The 35 mm and 40 mm Freesolve™ devices are intended to address the needs of selected patients whose lesions extend beyond the coverage offered by shorter scaffolds. Their performance will be assessed through the clinical programme before conclusions can be drawn about their appropriate application.
Teleflex stated that Freesolve™ RMS is commercially available only in countries accepting the CE mark. Commercial availability and use remain subject to the applicable regulatory requirements in individual markets.
Advancing Clinical Evidence in Coronary Intervention
The successful completion of patient enrollment in BIOMAG™-LL marks a milestone in Teleflex’s continued evaluation of resorbable magnesium scaffold technology.
By investigating 35 mm and 40 mm Freesolve™ RMS devices in de novo coronary lesions up to 38 mm, the study addresses a practical challenge in PCI: how to treat longer lesions while providing suitable vessel support and potentially limiting the need for extensive permanent stenting.
The trial’s 12-month target lesion failure endpoint and planned follow-up through 60 months will provide a framework for evaluating clinical outcomes over time. Its findings will complement the company’s ongoing BIOMAG™-III Pivotal Clinical Trial, which is also enrolling patients internationally.
Although the completion of enrollment does not establish the safety or effectiveness of the longer scaffold lengths, it represents progress toward obtaining the clinical evidence needed to assess their role in coronary intervention.
As the clinical programme advances, the resulting data may help physicians better understand the potential applications and limitations of longer resorbable magnesium scaffolds. For Teleflex, the studies form part of its broader effort to expand the Freesolve™ RMS portfolio and strengthen the evidence supporting its use in selected patients undergoing PCI.
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.
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