May 15, 2019 — Cordis, a Cardinal Health company, recently announced the full U.S. launch of its Radial 360 portfolio, offering a complete range of products to facilitate the transradial approach (TRA) for interventional cardiology procedures.
The transradial approach uses the radial artery in the wrist to access the body's arterial system, instead of using the femoral artery in the groin. This launch marks the beginning of a global radial product portfolio rollout. The Cordis Radial 360 portfolio is composed of:
Rain Sheath Transradial Thin-Walled Introducer;
Railway Sheathless Access System;
RBL-TG and RBL-JK Universal Shapes for the Infiniti and Super Torque Plus Diagnostic Catheters; and
Zephyr Vascular Compression Band
Compared to a femoral access approach, TRA in the wrist can offer fewer bleeding complications, faster post-procedure mobility, improved patient comfort and faster patient discharge, resulting in reduced in-hospital costs.1,2,3 TRA use in the U.S. is currently estimated to be approximately 30 percent of overall percutaneous coronary interventions and growing.4 In ST-segment elevation myocardial infarction (STEMI) patients alone, which represent the most severe type of heart attack, TRA use increased from 2 percent in 2009 to 23 percent in 2015.5 In Europe, Japan, China and Canada, TRA is currently used in the majority of cases.6,7
"The transradial approach has been an important advancement in how we treat coronary artery disease because of both the patient benefits, and the advantages realized by the hospital in terms of procedure flow and economics," said Kintur Sanghvi, M.D., FACC, FSCAI, associate medical director of interventional cardiology at Deborah Heart & Lung Center in Browns Mills, N.J., and inventor of the Railway System. "We look to the industry to help us advance the tools available for this technique, which Cordis has done with the introduction of the Radial 360 portfolio. In my experience with the Railway System, I see the clear advantage of downsizing the radial access by up to 2 French, a benefit that I'm unable to achieve with anything else that's currently on the market."
In addition to the Railway System, which received CE Mark in March 2017 and was U.S. Food and Drug Administration (FDA)-cleared in April 2018, the portfolio features the Rain Sheath Transradial Introducer. The introducer offers an ultra-low profile design, lubricious hydrophilic coating and proprietary Kink Recovery Technology that enables the sheath to maintain lumen patency throughout the procedure, even after a kink occurs.
"It's really exciting to have new and innovative tools to support complex radial revascularization procedures for our patients. These improvements in sheath and catheter technologies will enable us to increase radial adoption in the U.S. so that we can maximize PCI success while minimizing bleeding complications," said Kevin Croce, M.D., Ph.D., director of the Chronic Total Occlusion Complex Percutaneous Coronary Intervention Program at Brigham and Women's Hospital in Boston.
In addition, the RBL-TG and RBL-JK Universal Shapes build on the legacy of Cordis catheter technology, and the Zephyr Band is designed to simplify how a physician closes the procedure.
Cordis will showcase the Radial 360 portfolio at the Society for Cardiovascular Angiography and Interventions (SCAI) 2019 annual meeting, May 19-22 in Las Vegas.
For more information: www.cardinalhealth.com
1. Romagnoli E., Biondi-Zoccai G., Sciahbasi A., et al. Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study. Journal of the American College of Cardiology Volume 60, Issue 24, 18 Dec. 2012.
2. Mauricio G. Cohen and E. Magnus Ohman. Should the Benefit of Transradial Access Still Be Questioned? Journal of the American College of Cardiology: Cardiovascular Interventions. Volume 9, Issue 9, May 2016.
3. Amit P. Amin et al. Costs Associated with Access Site and Same-Day Discharge Among Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention. Journal of the American College of Cardiology: Cardiovascular Interventions. Volume 10, Issue 4, February 2017.
4. Data from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR).
5. Javier A. Valle, Lisa A. Kaltenbach, Steven M. Bradley, Robert W. Yeh, Sunil V. Rao, Hitinder S. Gurm, Ehrin J. Armstrong, John C. Messenger and Stephen W. Waldo. Variation in the Adoption of Transradial Access for ST-Segment Elevation Myocardial Infarction Insights from the NCDR CathPCI Registry. JACC: Cardiovascular Interventions. November 2017.
6. Zheng X, Curtis JP, Hu S, Wang Y, Yang Y, Masoudi FA, Spertus JA, Li X, Li J, Dharmarajan K, Downing NS, Krumholz HM, Jiang L; China PEACE Collaborative Group. Coronary Catheterization and Percutaneous Coronary Intervention in China: 10-Year Results From China PEACE-Retrospective CathPCI Study. JAMA Intern Med. 2016 Apr; 176(4): 512–521.
7. Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: Executive summary by the transradial committee of the SCAI*. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39.