The U. S. Food and Drug Administration has granted approval to C. R. Bard, Inc. for marketing its Flair™ Endovascular Stent Graft with an optimized delivery system. The device consists of a self-expanding Nitinol stent encapsulated within the proprietary ePTFE graft material of Bard. The product has received the indication  for use in the treatment of stenoses in synthetic arteriovenous bypass grafts. A six-month long study conducted by Bard showed that the placement of the device resulted in more than twice the primary patency of balloon angioplasty. “The Flair Endovascular Stent Graft represents the first interventional technology demonstrating superiority to balloon angioplasty in maintenance of access patency.

The U.S. Food and Drug Administration has cleared Lumen Biomedical, Inc.’s LBI Embolectomy System to remove fresh, soft embolus and thrombus from vessels in the peripheral vasculature. The device consists of a 0.014″ guide wire that consists of a 3D fiber-based element used along with the Xtract Aspiration Catheter that had been cleared previously. It is based on the same technology that drives Lumen’s embolic protection system. The system will be helpful in the treatment of Peripheral Arterial Disease.

The U.S. Food and Drug Administration has granted clearance to Physio-Control, Inc. for the commercialization of LIFEPAK 20e defibrillator/monitor in the United States. The device is an enhancement of the LIFEPAK 20. The new features include a stronger (Lithium-ion) battery and an on-screen fuel gauge. The novel version, also, is designed to facilitate easy transportation. This will help the hospitals to meet the standards set by Joint Commission for Accreditation of Healthcare Organizations to ensure the availability of resuscitation services in all the areas.