WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has completed enrollment of 102 patients in a European clinical study evaluating longer versions of its dissolvable magnesium coronary scaffold, advancing research into a potential alternative to permanent stents for patients with extensive coronary artery disease.
The BIOMAG-LL study enrolled patients at 14 European medical centers to assess the safety and clinical performance of 35-millimeter and 40-millimeter versions of the company’s Freesolve Resorbable Magnesium Scaffold.
The devices are being evaluated for treating previously untreated coronary artery lesions measuring up to 38 millimeters, a category that can present technical challenges during procedures to restore blood flow to the heart.
Long coronary lesions often require multiple stents or overlapping implants to provide sufficient coverage. Teleflex is investigating whether longer resorbable scaffolds could reduce the number of devices needed while providing temporary support to the affected artery.
Unlike permanent metallic stents, the Freesolve scaffold is designed to provide temporary structural support before gradually dissolving.
The study is a prospective, international, multicenter, single-arm premarket trial, meaning all participants receive the investigational treatment without a separate randomized comparison group.
Its primary endpoint is the rate of target lesion failure at 12 months, a composite measure used to evaluate outcomes following coronary interventions.
Patients will undergo clinical follow-up at one, six, 12, 36 and 60 months after treatment, allowing investigators to assess both near-term performance and longer-term outcomes.
Enrollment completion marks a clinical development milestone but does not establish the safety or effectiveness of the longer devices. Those conclusions will depend on the study’s results.
“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” said Flavio Ribichini, an interventional cardiologist involved in the study.
Ribichini said the findings would help determine whether longer Freesolve scaffolds could expand treatment options for patients with extensive coronary lesions.
The technology could also provide an alternative in cases where drug-coated balloons are considered but temporary structural support is needed to maintain the vessel wall.
Teleflex is separately evaluating the 35-millimeter and 40-millimeter scaffold lengths in its ongoing BIOMAG-III pivotal clinical trial, which is enrolling patients in the United States and international markets.
The parallel studies are intended to generate clinical evidence supporting the company’s efforts to expand the Freesolve product range.
“The study represents an important step in expanding the Freesolve RMS portfolio to address longer coronary lesions,” said Georg Nollert, vice president of medical affairs at Teleflex.
The existing Freesolve product line includes scaffold diameters of 2.5, 3.0, 3.5 and 4.0 millimeters, with lengths of 13, 18, 22, 26 and 30 millimeters.
Adding 35-millimeter and 40-millimeter options would extend the range of lesion lengths physicians could potentially treat with the technology.
Freesolve is currently commercially available only in countries that accept CE marking. The longer scaffold lengths remain under clinical evaluation.
For Teleflex, the completed enrollment moves its development program closer to generating evidence on whether resorbable magnesium scaffolds can provide a viable treatment option for longer coronary lesions while reducing reliance on permanent implants.
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