St. Jude Medical gets U.S. and European approval of Angio-Seal Evolution Vascular Closure Device

St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal Evolution Vascular Closure Device. The approval and global launch was announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.

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. 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 ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.

"The Angio-Seal Evolution takes a major step forward by automatically compacting the collagen," said Robert J. Applegate, M.D., Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "The confidence it provides physicians in closing the puncture in such a short period of time with such effectiveness is outstanding."

More than 13 million catheterizations are performed worldwide each year to open narrowed or blocked arteries and perform other cardiovascular procedures. During catheterizations, physicians insert a catheter (a thin tube) through a puncture made in the femoral artery in the upper thigh and guide it through the blood vessels to the point of care. Treatments such as balloons, stents and medications are then delivered through the catheter. Once a procedure is complete and the catheter is removed, bleeding from the puncture in the femoral artery must be stopped quickly.

Unlike most vascular closure devices, the Angio-Seal Evolution closure system is fully absorbed by the body within 60 to 90 days. This reduces risks associated with foreign material left permanently in the body and allows for repeat procedures without concerns about prior placement of closure devices.

"The Angio-Seal Evolution embodies St. Jude Medical's commitment to providing physicians with more control over patient outcomes while reducing procedural variability," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "We are confident the Evolution platform will further enhance Angio-Seal's position as the recognized leader in vascular closure and provide physicians with increased confidence in the ease of device deployment and predictability."

Prior to Angio-Seal, patients were required to endure 15 to 30 minutes of manual pressure at the catheter's access site in the leg, followed by four to 12 hours of bed rest to ensure that hemostasis was maintained. Most patients treated with Angio-Seal devices report significantly less discomfort after a catheterization and are able to resume normal activity more quickly. When Angio-Seal devices are used to seal vascular punctures made to diagnose cardiovascular conditions, most patients are able to walk within 20 minutes and leave the hospital one hour later.

Angio-Seal closure devices also increase hospital productivity and efficiency by reducing the length of patient stays in the catheterization lab or recovery area, thus providing potential cost savings.