Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent.
The Singapore-based company’s Leaders Free II study is an ongoing trial examining the use of the BioFreedom DCS in patients at high bleeding risk who receive an ultra-short dual anti-platelet drug regimen of 1 per month.
“We are excited to participate in the BioFreedom DCS US Pivotal IDE study and begin building the HBR patient database in America, which is a significant and relatively unstudied US population,” Dr. Michael Butler of Alabama’s Huntsville Hospital, who performed the 1st implant in the trial in the US, said in a prepared statement.
Biosensors said that the trial is ongoing, with patients being recruited at up to 85 clinical sites across Europe and North America.
“We are very excited to finally explore the unmet needs of these high bleeding risk patients, who historically have routinely been excluded from clinical trials of drug eluting stents,” trial principal investigator Dr. Mitchell Krucoff of Duke University said in a prepared release.
“Patients at high bleeding risk have not been sufficiently investigated in clinical trials and still present to the cath lab with limited options for safe and effective treatment. The polymer-free BioFreedom stent may help to address this unmet need for our most complex patients,” Dr. Marty Leon of Columbia University said in a press release.
The deal called for Cordis to sell the BioFreedom, BioMatrix NeoFlex, BioMatrix Alpha and Chroma stents made by Biosensors in Europe, the Middle East, Australia and New Zealand. Cordis said it plans to gradually roll out a new private-label brand for stents: Lumeno.