February 17, 2017 — Medtronic plc announced that its coronary portfolio will now include the DxTerity Diagnostic Angiography Catheter line and several transradial-specific products. Additional products include the DxTerity TRA, InTRAkit access kit and TRAcelet compression device, all of which received U.S. Food and Drug Administration (FDA) 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, atraumatic mini-guidewires, as well as tapered introducer sheaths that provide kink resistance and enhanced lubricity 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).
“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 Curriculum, 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.
A meta-analysis of randomized studies of the transradial approach generally have found that procedures via the transradial approach (through a patient’s wrist) have been associated with cost savings, reduced mortality and improved safety, with reductions in major bleeding and vascular complications.
The DxTerity and DxTerity TRA Diagnostic Catheters, TRAcelet compression device and the InTRAkit Access Kit are commercially available in the United Staets, as well as throughout Europe. The Transradial Arc Curriculum is only available in the U.S.
For more information: www.medtronic.com