FDA Approves Biosensors’ U.S. BioFreedom Trial

Biosensors International Group is undertaking a U.S. feasibility trial of its BioFreedom polymer-free, drug-coated stent system after receiving a conditional green light from the FDA.

The multicenter trial will evaluate the device’s safety and effectiveness in 100 adult patients with symptomatic ischemic heart disease from de novo stenotic lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm.

Patients will be assessed for major cardiac events such as heart attack, death and target lesion revascularization over a nine-month period. Results from the trial will go toward supporting a future pivotal investigational device exemption study, the company said Monday.

BioFreedom consists entirely of components developed by Biosensors, from the physical stent to the Biolimus A9 drug that coats the abluminal metal surface. The Singapore-based company claims that its drug has special lipophilic properties that improve action on smooth muscle cells and speed the transfer to cells in the vessel wall.

Biosensors interventional cardiology division markets three drug-eluting stents, two bare metal stents and three balloon dilatation catheters.

The BioFreedom stent is already CE-marked. — Lena Freund

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