FDA expands indication for Hospira’s Precedex

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.

Spiration, Inc’s IBV® Valve System receives HDE approval from FDA

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.

Ce Mark and FDA approval to St. Jude's Angio-Seal™ Evolution™ Vascular Closure Device

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.

Olympus to launch Spiration's IBV® Valve System

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for  patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

Medtronic, Inc launches Discyphor Direct™ Catheter System

Medtronic, Inc.’s Discyphor Direct™ Catheter System is now available in United States. Doctors use the second-generation catheter system to get more information on detecting the disc that causes discogenic low back pain. The system uses the company’s innovative Functional Anaesthetic Discography™ Procedure. Each disc is anesthetized individually for diagnosis of the disc that causes pain. Spine surgeons often use the procedure’s benefit in the form of diagnostic results to determine the best treatment for patients.