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FDA approval granted for BIOTRONIK's ultra-thin PRO-Kinetic Energy Cobalt Chromium Coronary Stent System

Press releases may be edited for formatting or style | February 16, 2017 Cardiology

More information on the BIOHELIX-I clinical study is available at www.ClinicalTrials.gov (identifier: NCT01612767).


About PRO-Kinetic Energy Cobalt Chromium (CoCr)
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Coronary Stent System
The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent features ultra-thin struts of only 60 µm* and a unique double-helix design, resulting in exceptional flexibility and deliverability even in challenging vessels. The stent is made from a cobalt chromium alloy and is coated with proBIO, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue. PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent platform also forms the basis of the Orsiro** Hybrid Drug-Eluting Stent and the PK Papyrus*** stent system for treating acute coronary
artery perforation.


About BIOTRONIK
A global leader in cardio-and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris***, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar**, the world's first 4 F compatible stent for treating long lesions; Orsiro**, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

* Sizes up to 3.0 mm
** CAUTION – Investigational device. Limited by United States law to investigational use.
*** Not currently available in the United States.


SOURCE BIOTRONIK

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