BIOTRONIK has enrolled the final patient in the BIOHELIX-I clinical trial. The BIOHELIX–I trial is designed to evaluate the safety and efficacy of the PRO-Kinetic Energy coronary bare metal stent and supports US Food and Drug Administration approval for the treatment of coronary arteries. BIOTRONIK previously received CE mark approval for PRO-Kinetic Energy in 2009.
“The ultra-thin strut PRO-Kinetic Energy stent has a low profile and is extremely deliverable,” comments national principal investigator for the study Saurabh Gupta, director of the Cardiac Catheterization Laboratory at Oregon Health & Science University, Portland, Oregon.
The BIOHELIX-I prospective, non-randomised, multicentre study has enrolled 329 patients in the USA, Europe and South America. The primary endpoint for the study is the rate of target vessel failure nine months after stent implantation, a composite endpoint encompassing cardiac death, myocardial infarction and ischaemia-driven target vessel revascularisation.
PRO-Kinetic Energy is an ultrathin strut (60μm / 0.0024“) cobalt chromium, bare metal stent, completely sealed with a thin layer of amorphous silicon carbide, called proBIO. This passive coating is known to reduce metal ion release from the stent, limiting adverse events post-implantation.
PRO-Kinetic Energy was previously evaluated for safety and effectiveness in the ENERGY registry, an all-comers registry, which studied more than 1,000 patients in Europe and Israel. The ENERGY registry studied more than 1,000 patients with a complex population of 39% B2/C lesions and 46% acute coronary syndrome patients. At 12 months, PRO-Kinetic Energy demonstrated a low 8.8% major adverse cardiac events (MACE) rate, including a 3.4% rate of target lesion revascularisation. A sub-group analysis showed similarly low 12-month MACE rates in acute coronary syndrome (ACS) patients, elderly patients, and patients with small vessels or diabetes.
“The PRO-Kinetic Energy stent has already proven itself as an excellent treatment option for over half a million patients,” says Daniel Buehler, president of BIOTRONIK Vascular Intervention. “The BIOHELIX-I trial brings BIOTRONIK one step closer to achieving its goal of offering US physicians a complete portfolio of innovative solutions for treating coronary disease.”