BIOHELIX-I Trial Evaluates Biotronik's Pro-Kinetic Energy Stent

December 17, 2012—Biotronik, Inc. (Lake Oswego, OR) announced the commencement of the BIOHELIX-I trial in the United States. The trial is designed to evaluate the safety and performance of the company's Pro-Kinetic Energy coronary bare-metal stent. The first implantation in the trial was performed by H. Barrett Cheek, MD, of Carolina Cardiology Cornerstone, at High Point Regional Hospital in High Point, North Carolina.

The Pro-Kinetic Energy is a thin-strut (60 μm/.0024 inches) cobalt-chromium bare-metal stent that is completely sealed with a thin layer of amorphous silicon carbide called Probio, a passive coating that is designed to reduce the amount of ions released from the stent, potentially reducing adverse reactions postimplantation, stated the company.

According to the company's press release, the BIOHELIX-I trial is a prospective, nonrandomized, multicenter, investigational device exemption study that will utilize Biotronik's Pro-Kinetic Energy coronary stent system in patients with symptomatic ischemic heart disease. More than 300 patients will be enrolled in this study. The National Principal Investigator of the BIOHELIX-I study is Saurabh Gupta, MD. Dr. Gupta, who is Director of the Cardiac Catheterization Laboratory at Oregon Health & Science University in Portland, Oregon, commented on the Pro-Kinetic Energy device in the company's press release.

“The thin cobalt-chromium struts of the Pro-Kinetic Energy allow for greater flexibility and a reduced crossing profile, which translates into a highly deliverable stent,” stated Dr. Gupta. “The clinical safety and performance of the Pro-Kinetic Energy stent has been demonstrated in recent results of the ENERGY Registry presented at the TCT conference (the 2012 Transcatheter Cardiovascular Therapeutics scientific symposium, held in Miami, Florida on October 22–26). The BIOHELIX-I study will provide additional insight and experience into the clinical application of the Pro-Kinetic Energy stent for patients with ischemic heart disease.”

In its press release, Biotronik advised that the ENERGY registry was an all-comers registry of more than 1,000 patients with a complex population of 39% B2/C lesions and 46% acute coronary syndrome patients. At 12 months, the Pro-Kinetic Energy showed 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, reported Biotronik.