Enrollment Begins in United States for BIOFLOW-V Study of Biotronik's Orsiro Hybrid DES

June 18, 2015—Biotronik announced that the first patient in the United States has been enrolled in the BIOFLOW-V clinical study, which is evaluating the safety and effectiveness of the company’s Orsiro hybrid drug-eluting stent (DES). The initial procedure in the United States was performed by David Trice, MD, at Thomas Hospital in Fairhope, Alabama.

The company stated that the BIOFLOW-V study is a prospective, international, multicenter, randomized controlled investigational device exemption trial. The primary endpoint is target lesion failure at 12 months after the index procedure. Eligible patients with coronary artery disease will be randomized in a 2:1 ratio to receive either Orsiro or another currently marketed DES. The study is planned to enroll 1,334 prospective patients at up to 150 sites in the United States, Canada, Europe, Israel, and the Asia Pacific region. The Orsiro hybrid DES was launched in Europe in 2011.

Biotronik is collaborating with Harvard Clinical Research Institute (HCRI) to conduct BIOFLOW-V. Additionally, Biotronik advised that it plans to add a Vascular Intervention division in the United States to complement its established Cardiac Rhythm Management business.

The Principal Investigator of the BIOFLOW-V study is David Kandzari, MD, of Piedmont Heart Institute in Atlanta, Georgia. Dr. Kandzari commented in the company’s press release, “Based on the encouraging previous study results, I am very excited that enrollment in the BIOFLOW-V study has started and Biotronik can begin the process of bringing this remarkable product to US patients. As a treatment option, I have no doubt Orsiro will benefit both patients and physicians in the United States as it has for the past 4 years in Europe.”

In May, the company announced that 1-year data from the industry-independent SORT OUT VII trial, which were presented at EuroPCR 2015, showed Orsiro to be noninferior to the Nobori stent (Terumo Interventional Systems) in a large, all-comers population. In that trial, Orsiro demonstrated enhanced safety and a significantly lower rate of stent thrombosis (0.4% of patients in the Orsiro arm vs 1.2% in the Nobori arm; P = .03). 

Biotronik noted that Orsiro has been supported by results in European trials including BIOSCIENCE, which was presented at the European Society of Cardiology’s ESC Congress 2014 in Barcelona, Spain, and published by Thomas Pilgrim, MD, et al in The Lancet (2014;384:2111–2122). In BIOSCIENCE, Orsiro was noninferior compared to Abbott Vascular’s Xience stent family in a patient population reflective of routine clinical practice.

Orsiro also demonstrated angiographic and clinical noninferiority to Xience Prime in BIOFLOW-II, a prospective, international, multicenter, randomized trial, which evaluated the safety and efficacy of Orsiro. Subgroup analyses of BIOFLOW-II and BIOFLOW-III, an all-comers registry, also demonstrated low restenosis rates in small vessels and complex B2/C lesions, reported the company.