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|Medtronic Expands Coronary Portfolio to Include New DxTerity(TM) Diagnostic Catheters and Suite of Tools for the Transradial Approach|
Full Line of Innovative Transradial Products and Comprehensive Training Programs Reinforce Medtronic's Commitment to Optimizing the Treatment of Heart Disease
DUBLIN - Feb. 13, 2017 - Medtronic plc (NYSE: MDT) today announced that its market-leading coronary portfolio will now include the DxTerity Diagnostic Angiography Catheter line and several transradial-specific products including the DxTerity TRA(TM), InTRAkit(TM) access kit and TRAcelet(TM) compression device, all of which received U.S. FDA (Food and Drug Administration) clearance and CE (Conformité Européenne) Mark for use in diagnostic cardiac catheterization procedures and percutaneous coronary intervention (PCI).
The DxTerity and DxTerity TRA Diagnostic Catheters are used to determine whether or not revascularization is necessary in patients with coronary artery disease; the DxTerity TRA Diagnostic Catheters are specifically designed for transradial access and allow for engagement of both coronary arteries without catheter exchange. The InTRAkit access kit enhances the transradial experience by providing several component pieces-ergonomic needles that offer excellent flashback visualization,1, 2 atraumatic mini-guidewires, as well as tapered introducer sheaths that provide kink resistance3 and enhanced lubricity4 for easy insertion. The TRAcelet compression device simplifies pressure reduction post-transradial catheterization by facilitating access site patent hemostasis (i.e., stops bleeding while maintaining radial artery patency).5
"The global approval of the DxTerity Diagnostic Catheters, as well as the introduction of the new Medtronic suite of transradial products represents a significant step forward for patients requiring PCI procedures," said Sunil Rao, M.D., interventional cardiologist and associate professor of medicine at Duke University, in Durham, N.C. "It's increasingly important to have a full suite of products accompanied by robust training to increase physician utilization, improve patient comfort and enable same-day discharge."
In the United States, Medtronic also launched the Transradial Arc CurriculumSM, a fully-customizable education and training solution for physicians, staff and administrators to ensure successful adoption of the transradial approach from access to patent hemostasis. The curriculum aims to provide robust clinical training and enhance patient care pathways through a hospital-specific approach to help institutions optimize the delivery of transradial care.
"Our new line of comprehensive transradial products and programs that support PCI from start to finish were developed to meet the evolving clinical and health economic needs of physicians, administrators and cath lab teams around the globe," said Jason Weidman, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. "Our intent with these recent innovations in our premium product portfolio is to help accelerate adoption of the transradial approach so that more patients and hospitals may experience the advantages transradial access can bring."
A meta-analysis of randomized studies that studied the transradial approach generally have found that procedures via the transradial approach (through a patient's wrist) have been associated with cost savings,6, 7, 8 reduced mortality and improved safety with reductions in major bleeding and vascular complications.9
The DxTerity and DxTerity TRA Diagnostic Catheters, TRAcelet compression device and the InTRAkit Access Kit are commercially available in the U.S., as well as throughout Europe. The Transradial Arc Curriculum is only available in the U.S.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Preclinical studies on file at Medtronic. Preclinical data may not be indicative of clinical results.
2 Based on physician feedback during preclinical study and compared to participants' current clinical experience; data on file at Medtronic.
3 Bench test data on file at Medtronic. Bench test data may not be indicative of clinical results.
4 Bench test data on file at Medtronic. Bench test data may not be indicative of clinical results.
5 Data on file at Medtronic
6 Amin AP et al. J Am Coll Cardiol. 2012;59;E338.
7 Jolly SS et al. The Lancet. 2011;377(9775):1409-1420.
8 Ewen et al. J Interv Cardiol. 2009;22(3):266-273.
9 Giuseppe F et al. J Coll Cardiol Intv 2016;9:1419-34.