FDA approved Orsiro’s BIOTRONIK ultrathin stent for treating coronary heart disease
On February 22, 2019, BIOTRONIC announced the FDA's approval of a drug-eluting stent (DES) stent, called Orsiro.
Orsiro is the first and only ultrathin stent surpassing existing clinical standards. He received the CE label in 2011 and today is used to treat over a million patients worldwide.
The unprecedented clinical efficacy of Orsiro in the central BIOFLOW-V study showed significantly lower rates of target damage in myocardial infarction after 12 months compared to Xience in a large and complex patient evaluation (total number 1344). Two years after the installation of Orsiro, the performance was further improved compared with Xience, including a significant decrease in revascularization of the affected muscle and the development of spontaneous MI.
The two-year results, presented in 2018 and published in the Journal of the American College of Cardiology, indicated a decrease in target damage by 37% in favor of Orsiro (7.5% versus 11.9%). Also, the incidence of lesion of the target target caused by ischemia was lower by 47%, while the incidence of spontaneous myocardial infarction decreased by 70%.
“Orsiro has set a new standard for clinical safety and efficacy, including a statistically lower revascularization of the lesion area and the incidence of myocardial infarction,” said Dr. David Kanzari, principal investigator of BIOFLOW-V in the United States. “BIOFLOW-V data are the best clinical results observed to date. In many respects, it was thought that the already obtained performance indicators were unsurpassed, but Orsiro proves that we can further reduce the incidence of heart attack through innovation. ”
For use in percutaneous coronary procedures, a chromium and cobalt metal stent is coated with BIOlute ™, a bioabsorbable BIOTRONIK polymer coating. Under the bioabsorbable layer is proBIO ™ BIOTRONIK, a passive coating on a bare metal surface, designed to reduce the release of nickel ions. The Orsiro stent system provides the ultra-thin stent base without compromising its strength and crossbreeding profile.
Today, the stent is available in 52 sizes from 2.25 to 4.0 mm in diameter and up to 40 mm long. The longest is currently available only in the United States.
“The FDA approval of Orsiro is changing the dynamics of the market in which there is a high degree of commercialization,” said Ryan Walters, president of BIOTRONIK, Inc. “We developed the Orsiro for use even in complex cases with functions that make it unlike any other DES. At the same time, interventionists can rely on Orsiro's ability to treat complex lesions and to achieve unprecedented results. Patients, doctors, and health care systems deserve the best. "
BIOTRONIK is a medical technology company that develops reliable and innovative solutions for the cardiovascular and endovascular systems. Guided by goals and principles, BIOTRONIK has been working with hospitals and health systems for over 50 years, helping to save and improve the lives of millions of patients with heart and vascular diseases.Headquartered in Berlin, Germany, BIOTRONIK has a representative office in more than 100 countries.
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