BIOHELIX-I Trial Enrollment Completed for Biotronik's Pro-Kinetic Energy BMS

December 2, 2014—Biotronik announced that the final patient has been enrolled in the BIOHELIX-I clinical trial, which is designed to evaluate the safety and efficacy of the company’s Pro-Kinetic Energy coronary bare-metal stent (BMS). 

According to Biotronik, the study will be used to support US Food and Drug Administration approval for the treatment of coronary arteries. The company received European CE Mark approval for the Pro-Kinetic Energy device in 2009.

BIOHELIX-I is a prospective, nonrandomized, multicenter study that has enrolled 329 patients in the United States, Europe, and South America. The primary endpoint for the study is the rate of target vessel failure 9 months after stent implantation. This composite endpoint encompasses cardiac death, myocardial infarction, and ischemia-driven target vessel revascularization.

Pro-Kinetic Energy is an ultrathin strut (60 μm/0.0024 inch) cobalt chromium BMS that is completely sealed with a thin layer of amorphous silicon carbide, called proBio. This passive coating reduces metal ion release from the stent, limiting adverse events postimplantation. The device’s double-helix design provides exceptional flexibility and deliverability, even in challenging vessels. The Pro-Kinetic Energy BMS platform also forms the basis of the company’s Orsiro hybrid drug-eluting stent and the PK Papyrus stent system for treating acute coronary artery perforation.

Saurabh Gupta, MD, serves as National Principal Investigator for the BIOHELIX-I study. He commented in the company’s press release, “The ultra-thin strut Pro-Kinetic Energy stent has a low profile and is extremely deliverable. I look forward to this innovative technology being available to all of my patients requiring treatment with a bare-metal stent.” Dr. Gupta is Director of the Cardiac Catheterization Laboratory at Oregon Health & Science University in Portland, Oregon.
    
Biotronik advised that the Pro-Kinetic Energy BMS was previously evaluated for safety and effectiveness in the ENERGY registry. This all-comers registry studied more than 1,000 patients in Europe and Israel with a complex population of 39% B2/C lesions and 46% acute coronary syndrome patients. At 12 months, the Pro-Kinetic Energy BMS demonstrated a low 8.8% major adverse cardiac events rate, including a 3.4% rate of target lesion revascularization. A subgroup analysis showed similarly low 12-month major adverse cardiac events rates in acute coronary syndrome patients, elderly patients, and patients with small vessels or diabetes.