St. Jude Medical has announced receipt of FDA and European regulatory approvals for the Engage and Engage TR line of introducers for cardiac catheterization procedures. The firm believes the new products’ design will facilitate safer arterial access and subsequent closure following the procedure.
St. Jude Medical designed the Engage Family of Introducers with features intended to minimize trauma to the artery and set the stage for closure using Angio-Seal(TM) or other closure devices.
The Engage Family of Introducers was designed to create a smooth and reliable means of accessing vasculature for a wide variety of patients and procedures. The Engage Introducer is used for femoral access, in which physicians access the patient’s heart through the femoral vein or artery located near the groin; this portfolio includes 22 model configurations of varying sizes to accommodate a wide variety of procedures. The Engage TR Introducer portfolio includes 18 model configurations and expands the company’s product offering to include introducers used to facilitate transradial (TR) procedures, in which physicians access the patient’s heart through the radial artery in the arm.
Though uncommon, some risks reported by physicians during interventional and diagnostic procedures include bleeding, vessel trauma, vasospasm (a condition that causes the vessel to constrict), or formation of blood clots within the introducer. The Engage Family of Introducers incorporates new features that were designed to offer physicians more control and minimize these risks both during access and throughout the procedure.