St Jude Medical announced on 11 March 2010 FDA clearance and European CE mark approval for the Engage and Engage TR Introducers.
The new Engage Family of Introducers, uniquely designed to provide physicians with reliable access, enhance the company’s portfolio of introducers which have been trusted by physicians for nearly 20 years. Drawing upon its experience in both access and closure, St Jude Medical designed the Engage Family of Introducers with features intended to minimise trauma to the artery and set the stage for closure using Angio-Seal 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; 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 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 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 (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 minimise these risks both during access and throughout the procedure.
“St Jude Medical is focused on developing products that reduce risk and improve physician control during procedures,” said Frank Callaghan, president of St Jude Medical’s Cardiovascular Division. “The Engage Introducers were designed to provide physicians with reliable femoral and radial vascular access that can be easily repeated for any patient, no matter their individual anatomy or medical history.”