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BIOTRONIK completes enrollment for iliac arm of BIOFLEX-I trial

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Biotronik has announced completion of the iliac arm of the BIOFLEX-I trial, which will assess the safety and efficacy of the Astron and Pulsar-18 stents for the treatment of peripheral vascular disease.

The prospective, nonrandomized, multicenter, Investigational Device Exemption trial will include two arms: iliac and superficial femoral artery (SFA). One hundred sixty patients at 34 sites in the United States and Europe had Astron stents that were successfully implanted in the iliac artery. Enrollment in the SFA arm is ongoing.

The Astron stent is CE marked and available in more than 50 countries. The company is seeking FDA approval for use in the United States.

“The completion of enrollment in the iliac arm of this study represents an important milestone in Biotronik’s goal to deliver our innovative peripheral intervention products to US physicians,” Daniel Bühler, president of vascular intervention at the company, said in a press release. “We look forward to positive results from this portion of BIOFLEX-I, and feel sure that we will ultimately be able to provide physicians with further proven treatment options for cardiovascular disease.”