Teleflex reports four-year study data on resorbable heart scaffold

Teleflex Incorporated (NYSE: TFX) announced four-year follow-up results from its BIOMAG-I clinical study of the Freesolve Resorbable Magnesium Scaffold at the EuroPCR conference in Paris. The study, which enrolled 116 patients across European centers, showed no new cardiac-related events between the two and four-year follow-up periods.

The data presented by Prof. Jan Torzewski from Klinikverbund Allgäu, Germany, indicated no cardiac deaths, target-vessel myocardial infarctions, or scaffold thrombosis through four years. The target lesion failure rate was 3.5%, with only one event occurring beyond the scaffold's one-year resorption period.

"The absence of cardiac death, target-vessel MI, or scaffold thrombosis throughout four years, combined with the very low TLF rate, is highly promising," said Prof. Michael Haude, the study's principal investigator and a paid Teleflex consultant.

The Freesolve scaffold is made from Teleflex's proprietary BIOmag Magnesium Alloy and maintains a 12-month resorption time. The device is designed to provide temporary mechanical support while avoiding permanent implant complications.

These results support ongoing BIOMAG-II and pending BIOMAG-III randomized controlled trials, which aim to demonstrate the scaffold's effectiveness compared to drug-eluting stents. The device is commercially available in countries accepting CE-mark approval but remains investigational in the United States.

The company stated the findings provide confidence for the scaffold as a treatment option where avoiding permanent implants is desired. Information is based on the company's press release statement.

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