St. Jude Medical Announces U.S., European Approval of Vascular Closure Device


October 14, 2008

October 14, 2008 - St. Jude Medical Inc. said today at TCT 2008 that the FDA and European CE Mark approval of the Angio-Seal Evolution Vascular Closure Device.

The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.

The Angio-Seal Evolution platform features an entirely new delivery system that significantly reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system, said the company. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). With Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site. The new device’s automated collagen compaction system reportedly ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians reportedly gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.

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