FDA clears Medtronic products for diagnostic cardiac catheterization procedures, PCIs

The FDA cleared Medtronic’s DxTerity diagnostic angiography catheter line and several of the company’s transradial-specific products, all of which are used in diagnostic cardiac catheterization procedures and PCIs.

The transradial-specific products include the DxTerity TRA, InTRAkit access kit and TRAcelet compression device.

Medtronic announced the approvals in a Feb. 13 news release. The products also received a CE Mark for use in Europe.

Medtronic said the DxTerity and DxTerity TRA diagnostic catheters determine if patients with coronary artery disease require revascularization. The DxTerity TRA is designed for transradial access.

Meanwhile, the InTRAkit includes ergonomic needles, atraumatic min-guidewires and tapered introducer sheaths that enhance the transradial experience. In addition, the TRAcelet compression device provides access site patent hemostasis.

Medtronic also launched the Transradial Arc Curriculum, an education and training program in the U.S. The curriculum is intended to allow physicians, staff and administrators to adopt the transradial approach. The company said randomized trials have found the transradial approach was associated with cost savings, reduced mortality and reductions in major bleeding and vascular complications.