Bioresorbable-polymer, sirolimus-eluting Orsiro outperformed Abbott’s market-leading Xience durable-polymer, everolimus-eluting stent at the two-year follow-up in the BIOFLOW V trial. The company stresses that Orsiro is the first and only ultrathin drug-eluting stent to beat Xience in a randomized trial.
US FDA approved Biotronik SE & Co. KG Orsiro cobalt chromium bioresorbable-polymer, sirolimus-eluting, ultra-thin strut coronary stent and the company has launched it in the US immediately, the company announced Feb. 22.
Orsiro earned a CE mark in 2011 and has been used in over a million patients, according to the company.
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MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
