March 11, 2010 – The FDA cleared a new family of introducers which offer features intended to minimize trauma to the artery and set the stage for closure using a closure device. The products also recently gained European CE mark approval.
St. Jude Medical’s Engage and Engage TR family of introducers is 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.
“The new Engage family of Introducers help to set the stage for a successful procedure by reducing the number of potential variables that can affect patient outcome,” said Dr. Javier Goicolea from Hospital Puerta de Hierro in Majadahonda, Spain. “While some introducers were designed to just perform the basic access function, the Engage introducers were designed with the entire procedure in mind, including a successful closure.”
Though uncommon, some risks reported by physicians during interventional and diagnostic procedures include bleeding, vessel trauma, vasospasm, or formation of blood clots within the introducer. The Engage introducers incorporate features that offer physicians more control and minimize these risks both during access and throughout the procedure.
For more information: www.sjm.com