Biotronik’s Orsiro Mission BP-DES Approved and Launched in the United States

September 30, 2021—Biotronik announced it received FDA approval of its Orsiro Mission bioabsorbable polymer coronary drug-eluting stent system (BP-DES). The company also announced the first implantation and the full commercial availability of the device in the United States. In February 2020, the company announced European CE Mark approval for the Orsiro Mission BP-DES.

According to Biotronik, the Orsiro Mission DES features the same stent design and bioabsorbable coating with controlled drug release as the company’s Orsiro stent. Improvements to the new Orsiro Mission DES system include a re-engineered delivery system and a new deep embedding process to further improve deliverability including trackability and crossability.

“We welcome the availability of the Orsiro Mission DES in the United States as a novel percutaneous coronary intervention device offering better outcomes,” commented David Kandzari, MD, in the company’s press release. “The outstanding deliverability and the extensive clinical data give strong evidence for continued Orsiro Mission adoption.”

Dr. Kandzari is Chief of the Piedmont Heart Institute and Cardiovascular Service Line; Director, Interventional Cardiology of the Piedmont Heart Institute; and Chief Scientific Officer for Piedmont Healthcare in Atlanta, Georgia. Dr. Kandzari’s facility is among the first to receive the newly approved device.

The company noted that the Orsiro DES clinical program includes the pivotal BIOFLOW-V trial.

In February 2020, the company announced that the 3-year data from the BIOFLOW-V trial were presented at CRT 2020, the Cardiovascular Research Technologies scientific conference held in National Harbor, Maryland. The study results were published simultaneously by Dr. Kandzari, et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2020;13:1343–1353).

Additionally, the Orsiro device was evaluated in the investigator-initiated, multicenter BIOSTEMI study conducted in Switzerland. On March 22, 2021, the final 2-year outcomes from the study were published by principal investigator Professor Thomas Pilgrim, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2021;14;639-648). Prof. Pilgrim also presented the BIOSTEMI findings on March 13 at the Cardiovascular Research Technologies’ CRT Virtual 2021 conference.