St. Jude Medical, Inc. announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal(TM) 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 more quickly, enabling the patient to walk and resume activities sooner.

The Angio-Seal Evolution platform features a 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 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.

More than 13 million catheterizations are performed worldwide each year to open narrowed or blocked arteries and perform other cardiovascular procedures. Once a procedure is complete and the catheter is removed, bleeding from the puncture in the femoral artery must be stopped quickly.

"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."

"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."

Patients are usually required to have 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. According to the company, patients treated with Angio-Seal devices report significantly less discomfort after a catheterization and are able to resume normal activity more quickly, and most patients are able to walk within 20 minutes and leave the hospital one hour later.

Adapted from a press release by St. Jude Medical.

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