Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter. It has been developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. The Apex Catheter is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. It represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility.

The U.S. Food and Drug Administration has granted the marketing approval to Salix Pharmaceuticals’ APRISO (mesalamine) extended-release capsules 0.375 g. A locally-acting aminosalicylate, APRISO has been approved for the remission of ulcerative colitis (UC) in adults. APRISO is the only mesalamine product to receive an FDA approval as once-daily drug for the maintenance of remission of UC. Also, it is the first ever 5-ASA with Intellicor(TM) extended release delivery technology. The product will be available to physicians by early 2009.

The U.S. Food and Drug Administration has expanded the indication for Hospira, Inc.’s Precedex(R) for use in non-intubated patients needing sedation before or during surgical procedures. Anesthesiologists, now, can administer Precedex safely for a growing number of out-patient applications like ophthalmic and orthopedic procedures.The broader indication is based on the results of two clinical trials involving 431 patients.

The U.S. Food and Drug Administration has given Humanitarian Device Exemption (HDE) approval to Spiration, Inc. to use its IBV® Valve System for controlling air leaks which may become prolonged after procedures such as lung volume reduction surgery. This is the first approval from FDA for a bronchial valve implant for the lungs. Conventional treatments such as surgery can lead to complications and are expensive. This minimally invasive system is a safer and cheaper alternative.

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

The U.S. Food and Drug Administration has given the approval in the form of a Humanitarian Device Exemption (HDE) for Levitronix’s CentriMag Right Ventricular Assist System providing patients in critical condition with temporary aid for the right ventricle of their heart. The heart pump supports the pumping action of a heart not functioning properly. The indication facilitates the development of the device for treatment of the severe right-side heart failure, which although uncommon, can lead to death. The device was found to be safe for use.

Teva Pharmaceutical’s ProAir HFA, an albuterol sulfate inhalation solution has received an expanded indication from the U.S. Food and Drug Administration for treating bronchospasm in children suffering with reversible obstructive airway disease. Previously approved for patients above 12 years of age, ProAir HFA is now recommended for patients older than 4 years. The indication was expandedc on the basis of a 3-week long study which concluded that 2 inhalations of the solution 4 times a day treated the symptoms significantly.

Canadian company Clearwater’s DizzyFIX has been cleared by the U.S. Food and Drug Administration. The DizzyFIX is a low-cost visual-feedback device which easily attaches to a hat. Used as a guide to the Epley maneuvers it can be an effective treatment for the most common cause of vertigo, Benign Paroxysmal Positional Vertigo (BPPV). The device that has been developed by ENT specialists emerges as an alternative to the drug therapy that aims at simply masking the symptoms.

The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.