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FDA approves ultrathin bioabsorbable coronary stent
Biotronik announced that a drug-eluting stent system for the treatment of patients with CAD has been approved by the FDA and is commercially available in the U.S.
The DES (Orsiro, Biotronik) is used during PCI and elutes sirolimus through a bioabsorbable polymer coating (Biolute, Biotronik), according to a press release from the company. The system also has a coating that reduces nickel ion release, ultrathin stent struts and a low crossing profile.
FDA approval was supported by results of the BIOFLOW V trial, according to the press release.
As Cardiology Today’s Intervention previously reported, 2-year data from the BIOFLOW V trial found that patients with CAD who underwent PCI with Orsiro had reduced risk for target lesion failure and target vessel MI compared with patients assigned a thin, durable polymer everolimus-eluting stent (Xience, Abbott Vascular).
“Orsiro has set a new standard for safety and efficacy clinical endpoints including statistically lower target lesion revascularization and target vessel MI rates,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta and U.S. principal investigator of the BIOFLOW V trial, said in the release. “BIOFLOW V data are the best clinical outcomes witnessed with a modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation.”
The DES is available in 52 sizes with diameters that range from 2.25 mm to 4 mm and lengths up to 40 mm, which is the longest stent available in the U.S., according to the release.
Disclosure: Kandzari reports he received institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic and OrbusNeich and personal consultant honoraria from Boston Scientific, Cardiovascular Systems Inc. and Medtronic.