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 approved PMA supplement for Endologix, Inc.’s Powerlink XL® System that includes novel suprarenal stent grafts along with the Powerlink XL stent graft. The system used in the minimally invasive procedures to treat abdominal aortic aneurysms (AAA), now, has broadened indication. Endologix provides a choice to physicians for the optimal device for the treatment of various patient anatomies. This marks the entry of Endologix in a new market segment as 15% of endovascular AAA applications are for patients having aortic necks greater than 26 millimeters.

The U.S Food and Drug Administration (FDA) has given an unconditional Investigational Device Exemption to Berlin Heart Inc.’s EXCOR(R) Pediatric ventricular assist device (VAD).The device is a cardiac support system that is useful for pediatric patients who are critically ill and have been suffering from a severe heart failure. The system is a great support for patients waiting for a heart donor for transplantation.

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.

The U.S. Food and Drug Administration has given the 510(k) clearance Interrad Medical, Inc.’s SecurAcath(TM) PICC with Subcutaneous Securement System. The novel method for catheter securement uses a small anchor which is deployed in the subcutaneous tissue just under the skin to hold an indwelling catheter firmly in place. The catheters, currently in use, are secured on the surface of the skin of the patient using adhesive devices. The SecurAcath system also reduces the time for catheter maintenance, bringing down the costs related to it. The risk of infection related to catheter is also lowered by improved cleaning of exit site and minimizing the motion.

The U.S. Food and Drug Administration has approved the commercialization of Boston Scientific Corporation’s TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary Stent System. Designed for the treatment of small coronary vessels, the system is the first drug-eluting stent (DES) which has got the FDA approval for sale in the American market for use in vessels smaller than 2.25 mm in diameter.

The U.S. Food and Drug Administration (FDA) has approved Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. This generic product from the company is pharmaceutically equivalent to Cardiolite®1, a myocardial perfusion imaging agent that is used to detect coronary artery disease. The kit from Covidien will now be available in the market of United States.

The US Food and Drug Administration (FDA) has broadened the approval to W. L. Gore & Associates for its GORE VIABAHN Endoprosthesis. The company can now market its product for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 - 12.0 mm. Till now, this range had been limited to 4.0 - 7.5 mm. Gore is, now,  the only company with a stent-graft approved for both the SFA and iliac arteries.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Cardica, Inc. to market its PAS-Port(R) Proximal Anastomosis System for use in cardiac bypass surgery. The system creates a safe connection (anastomosis) between a vein graft and the aorta (the main artery in the human body) during coronary artery bypass grafting (CABG) procedures. The current method requires that the aorta be clamped which leads to the release of tiny blood clots or particles from it. These can reach the brain and cause stroke and other neurological complications.