BIOTRONIK has announced that its PRO-Kinetic Energy stent has now been implanted in initial patients in the U.S. in the BIOHELIX-I trial. The bare metal coronary stent is made of cobalt chromium that allowed the creation of struts with a 60μm (0.0024 inch) width. It’s also coated with an amorphous silicon carbide called PROBIO that limits the release of ions from the stent, hopefully reducing the quantity of platelets gathering around the stent and helping with endothelialization.
The cobalt/chromium construction permits greater flexibility and a narrower crossing profile over commonly used nitinol stents. The stent also features BIOTRONIK’s new Pantera balloon technology that promises a smooth and effortless delivery of the device.
More from the announcement:
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.
Saurabh Gupta, M.D., 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) rate including a 3.4% rate of target lesion revascularization (TLR). 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.
Product page: PRO-Kinetic Energy
Press release: BIOTRONIK Announces First U.S. Implants of PRO-Kinetic Energy Stent in BIOHELIX-I IDE Clinical Trial
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