Biotronik Releases New Versions of Drug-Eluting Stent

Biotronik has released new 35mm and 40 mm versions of Orsiro, the industry’s first hybrid drug-eluting stent (DES) featuring a bioabsorbable polymer. Biotronik now offers one of the longest drug-eluting stents on the market across all diameters.

The Orsiro 40 mm was first implanted by Heinz-Joachim Büttner, M.D., of University Heart Center in Bad Krozingen, Germany. “The low strut thickness and good deliverability of Orsiro is even more evident in long lengths,” Büttner said. “With the addition of the new sizes, there is now an Orsiro available for almost every case.”

The efficacy and safety of Orsiro recently was demonstrated in two studies, Bioflow-II and Bioflow-III, which showed that Orsiro performs as best in class. Bioflow-II is a prospective, international, multi-center, randomized trial that evaluated the safety and efficacy of Orsiro compared to Abbott’s Xience Prime stent. At nine months, the results for the primary endpoint in-stent late lumen loss were 0.10 ±0.32 mm in the Orsiro arm and 0.11 ±0.29 mm in the Xience Prime arm evaluated by an independent core laboratory and confirming the non-inferiority hypothesis (p-value for non-inferiority <0.0001). No significant differences were reported for the clinical end-points at nine months. Additionally no stent thrombosis was reported in either arm.

“With the addition of the 35 and 40 mm lengths, Orsiro now has a complete size range. The new lengths, in combination with the great deliverability, means that physicians can use Orsiro across a wider range of lesions,” said Alain Aimonetti, vice president of sales and business development for Biotronik Vascular Intervention. “The results from the Bioflow-II and Bioflow-III trials demonstrate the performance of Orsiro and place it at the forefront of the stent market.”

Launched in 2011, Orsiro is a hybrid DES with a bioabsorbable polymer matrix. Orsiro’s solution for treating coronary artery stenosis consists of a hybrid combination of passive and active components. The Probio passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. The active coating, BIOlute, contains a highly biocompatible polymer that delivers a limus drug through a bioabsorbable matrix. This hybrid coating is layered on top of the high performance Pro-Kinetic energy stent platform, renowned for its advanced, thin-strut stent design and superior deliverability.

Biotronik SE & Co. KG is a privately held multinational biomedical technology company headquartered in Berlin, Germany. The company developed the first German cardiac pacemaker in 1963 and pioneered in the creation of remotely monitored implanted cardiac devices.