The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience, the company said.
At two years, data from the trial indicated a reduced event rate as compared to patients treated with the Xience, including a reduction in target lesion revascularization and spontaneous myocardial infarction.
“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” BIOFLOW-V US principal investigator Dr. David Kandzari of Atlanta’s Piedmont Heart Institute said in a press release.
The Orsiro is a cobalt chromium metal stent that elutes sirolimus through the company’s BIOlute bioabsorbable polymer coating, Biotronik said.
“The FDA approval of Orsiro changes the dynamic of what had become a highly commoditized DES market. We designed Orsiro for use even in challenging cases with features that make it unlike any other DES in the world. Hospital administrators now have available a DES that shows improved clinical event rates and interventionalists can rely on Orsiro’s deliverability to treat complex lesions6 and challenging subgroups to achieve unprecedented patient outcomes. Patients, physicians and health systems deserve the best, and that is exactly what we are bringing to the US market,” prez Ryan Walters said in a prepared statement.
Last October, Biotonik said that it received FDA approval for its PK Papyrus covered coronary stent system.