Biotronik Announces First U.S. Implants of PRO-Kinetic Energy Stent in BIOHELIX-I IDE Clinical Trial
LAKE OSWEGO, Oregon, December 17, 2012—BIOTRONIK announced that the first implant has taken place in the BIOHELIX-I trial in the United States. The BIOHELIX–I trial is set to evaluate the safety and performance of the PRO-Kinetic Energy coronary, bare-metal stent. The first implant was successfully performed by Dr. H. Barrett Cheek, of Carolina Cardiology Cornerstone, at High Point Regional Hospital in High Point, North Carolina.
The PRO-Kinetic Energy is a thin strut (60μm / 0.0024 inches) cobalt chromium, bare-metal stent, completely sealed with a thin layer of amorphous silicon carbide called PROBIO. This passive coating is designed to reduce the amount of ions released from the stent, potentially reducing adverse reactions post-implantation.
The BIOHELIX-I trial is a prospective, nonrandomized, multicenter, investigational device exemption (IDE) 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, which is registered on www.clinicaltrials.gov
Saurabh Gupta, MD, director of the Cardiac Catheterization Laboratory at Oregon Health & Science University in Portland, Oregon, is the National Principal Investigator of the BIOHELIX-I study. He said, “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.” Additionally, Dr. Gupta commented, “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 conference in Miami, Florida). 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.”
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, PRO-Kinetic Energy showed a low 8.8% major adverse cardiac events (MACE) [s1] rate including a 3.4% rate of target lesion revascularization (TLR)[s2] . A sub-group analysis showed similarly low 12-month MACE rates in acute coronary syndrome (ACS)[s3] patients, elderly patients, and patients with small vessels or diabetes.