Biotronik releases line-extension of Orsiro Hybrid Drug Eluting Stent

Biotronik has announced the market release of new 35 and 40 mm versions of Orsiro, the industry’s first hybrid drug eluting stent (DES) featuring a bioabsorbable polymer.

The Orsiro 40 mm was first implanted by German medic, Dr Heinz-Joachim Buttner, who said: "The low strut thickness and good deliverability of Orsiro is even more evident in long lengths. With the addition of the new sizes, there is now an Orsiro available for almost every case."

The efficacy and safety of Orsiro was recently demonstrated in two high-profile studies, BIOFLOW-II and BIOFLOW-III, which showed it performs as best in class.

BIOFLOW-II was a prospective, international, multi-centre, randomised trial which evaluated the safety and efficacy of Orsiro compared to Abbott’s XIENCE PRIME. 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,” said Alain Aimonetti, vice president of sales and business development, at Biotronik’s vascular intervention team. “The new lengths, in combination with the great deliverability, means physicians can use Orsiro across a wider range of lesions. The impressive results from the BIOFLOW-II and BIOFLOW-IIItrials demonstrate the excellent performance of Orsiro and firmly place it at the forefront of the stent market.”