FDAnews Device Daily Bulletin

ST. JUDE MEDICAL ANNOUNCES FDA APPROVAL, LAUNCH OF VASCULAR DEVICE

March 22, 2006
A A

St. Jude Medical has announced FDA approval of its next-generation vascular closure device, the Angio-Seal VIP. The device has also received CE Mark approval in Europe.

The new device is approved to stop bleeding following diagnostic and interventional angioplasty procedures, allowing hemostasis (clotting) to be achieved more quickly. The device's coated suture is designed to improve the process of sealing arterial catheterization sites, and its components are fully absorbed within 60 to 90 days.

The company noted that the device should help spare patients the customary 15 to 30 minutes of manual pressure at the access site and up to 24 hours of bed rest to ensure hemostasis is achieved. Patients treated with the device have been able to resume normal activity more quickly, and in most diagnostic cases to walk within 20 minutes and leave the hospital within one hour, according to the company.

Physicians who have used Angio-Seal VIP have pointed to the benefits of the new treatment. At Main Line Health in Bryn Mawr, Penn., the device has been used in more than 550 patients, according to Dr. Jack Martin, chief of cardiology. "We believe that the improvements have been noticeable, particularly in interventional procedures," he said.

Martin was involved in premarket evaluation of the new technology and noted that earlier patient ambulation and discharge "helps patients get back to their lives sooner, as well as reducing time and cost in the recovery room."

(http://www.fdanews.com/ddl target=_blank)