March 28, 2006

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March 28, 2006

March 28 – March April 3

March 31st: FDA Approves First Generic HIV/AIDS Drug in Capsule Form
for United States Market

The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services today issued the first generic approval for the capsule dosage form of zidovudine to treat HIV/AIDS to be marketed in the United States. The tablet and oral solution dosage forms of zidovudine were previously approved for sale in the United States when the patent on those dosage forms expired in September 2005. Today’s approval for the capsule formulation of the drug, which is manufactured by Aurobindo Pharma LTD. in Hyderabad, India, follows the expiration of GlaxoSmithKline’s patent on its capsule form of the product marketed under the trade name Retrovir.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which helps keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.

March 31st: Hypoguard Receives 510(k) Clearance to Market Assure(R) Pro Blood Glucose Monitoring System

Hypoguard announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Assure® Pro Blood Glucose Monitoring System. Assure®Pro is specifically designed for multi-resident use in long-term care (LTC) facilities. This full-featured system offers qcProGuard(TM), the first of its kind, 24-hour reminder to conduct daily control solution testing as required in LTC settings. A "Hypo" warning alerts users of low blood glucose readings and four programmable alarms can be used as test reminders. Assure Pro Test Strips are built using platinum technology and require a small blood sample size (1 uL). To test, simply insert the test strip in the convenient top-of-the-meter port. Results are displayed in 10 seconds on a large LCD and a backlight display (adjustable) assists for reading in low light conditions. A strip release button for strip disposal eliminates the need to touch a used strip, reducing the risk of exposure to infectious materials. For additional security, Assure Pro is designed with ProGrip(TM) to help secure a hold on the meter and reduce slipping on surfaces. The Assure Pro Blood Glucose Monitoring System will be available in April 2006.

April 3rd: FDA Approves Humanitarian Device Exemption for Treatment of Fetuses with Twin-To-Twin Transfusion Syndrome

The Food and Drug Administration (FDA) today announced the approval of a Humanitarian Device Exemption (HDE) for Fetoscopy Instrument Sets distributed by Karl Storz Endoscopy America, Inc., Culver City, Calif. under the Humanitarian Use Device (HUD) program for the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS).

TTTS is a rare disorder of the placenta that sometimes occurs when women are pregnant with identical twins. During the development of identical twins, blood vessels in the fetuses' shared placenta connect their blood circulations. In most cases, the blood flows properly through these vessels. However, in TTTS, the blood begins to flow unevenly, with one fetal twin receiving too much blood (the recipient) and one receiving too little (the donor). This can cause heart failure in the recipient twin and life-threatening anemia in the donor twin. Many of these babies do not survive delivery or are born with severe handicaps.

The Fetoscopy Instrument Sets are intended to be used for the treatment of TTTS for fetuses whose gestational age is between 16 and 26 weeks. The sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and fluid through the entry site. After identifying the communicating blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser is used to photocoagulate (destroy with heat) the communicating vessels which should help to normalize the flow of blood between the twins. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.

The HUD program encourages the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.S. per year. To receive approval of an HDE application, a sponsor must demonstrate that the safety and probable benefit of its device. Such products can only be used under the supervision of a local Institutional Review Board.

April 3rd: Siemens Receives FDA 510(k) Clearance for the MVision Megavoltage Cone Beam Imaging Package

The U.S. Food and Drug Administration (FDA) have granted Siemens Medical Solutions 510(k) clearance for the MVision(TM) Megavoltage Cone Beam (MVCB) Imaging Package. Commercially available worldwide, MVision is the latest innovation in Siemens' portfolio of Adaptive Radiation Therapy (ART) solutions.

MVision is a unique volumetric in-line target imaging solution and the natural next step in Image-Guided Radiation Therapy (IGRT). Designed to work with Siemens' linear accelerators, the system is the first commercial implementation of cone beam technology utilizing a standard radiotherapy treatment beam. MVision makes it possible for the megavoltage (MV) source used for treatment to also create a 3D image of the patient, enabling clinicians to "see inside" the patient at the most appropriate moment.

Megavoltage cone beam imaging has demonstrated excellent and clinically useful soft tissue contrast needed for many disease sites. MVision fully integrates and automates all processes, including acquisition, reconstruction, registration, assessment, patient positioning and clinical review. With a few simple steps, therapists can calculate 3D offsets, send them to the treatment couch to compensate for daily variations, and safely deliver therapy.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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