November 10, 2017 — Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now includes two coronary stents — the Tryton Side Branch Stent and Medinol’s NIRxcell, a cobalt-chromium bare metal stent (BMS). Cordis’ cardiology products were on display during the 29th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, Oct. 29-Nov. 2 in Denver.
The recent Cardinal Health agreement with Israel-based Medinol gives Cordis exclusive rights to sell Medinol’s coronary stent portfolio in the United States. Cordis is now selling Medinol’s NIRxcell BMS and, upon Medinol receiving U.S. Food and Drug Administration (FDA) approval, Cordis will also be the exclusive distributor of the EluNIR drug-eluting stent (DES). The EluNIR DES is currently an investigational device and not approved for commercial use in the U.S.
Medinol’s NIRxcell Bare-Metal Stent and EluNIR Drug-Eluting Stent are supported by a large body of clinical data, according to the company. The NIRxcell BMS has been tested on more than 1,000 patients and found highly effective in numerous clinical trials. Data from BIONICS, a global pivotal study of 1,919 patients from 76 sites in 8 countries, was submitted to the FDA to support U.S. regulatory approval of the EluNIR DES for the treatment of patients with narrowing or blockages to their coronary arteries. The EluNIR DES is currently an investigational device and not approved for commercial use in the U.S. Medinol recently received CE-mark and other regulatory clearances in Europe for the EluNIR stent.
The Tryton Side Branch Stent, the first dedicated bifurcation device to receive regulatory approval in the U.S., is approved for the treatment of de novo coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5mm stent). The device is built using proprietary Tri-Zone technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt-chromium stent is deployed in the side branch artery using a standard, single-wire, balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.
For more information: www.cordis.com