New Products

July 1, 2004



 

NEW PRODUCTS

Listings are for information only and do not constitute endorsements.

Jump to:Choose article section...New "smart" U/S system features "no-hands" voice command New drug approved for treating trichomoniasis FDA approves premixed FSH cartridge for self-injection by infertility patients Have mini U/S scanner, will travel  Two products for pelvic floor repair CORRECTION

New "smart" U/S system features "no-hands" voice command

The newly launched iU22 intelligent ultrasound system represents a new generation of smarter U/S equipment, says Philips Electronics of its new "flagship" U/S product for general imaging. The more automated, easier-to-use system not only promises the latest breakthroughs in high-definition imaging and diagnostic capability (as the first premium U/S system to have fully integrated 2D, 3D, and real-time 4D imaging modes, claims the manufacturer), but is also designed to reduce the repetitive stress injuries common to sonographers. Among the machine's bells and whistles: 17 MHz high-frequency transducers to display details of fetal anatomy in real-time, the ability to identify the nature of suspicious breast lesions with clear and immediate images, and voice recognition software and a shared-view flat panel screen designed for medical applications. For more information, visit the company's Web site at http://www.medical.philips.com/iU22 .

 

New drug approved for treating trichomoniasis

The Food and Drug Administration has approved Tindamax (tinidazole), a new second-generation 5-nitroimidazole compound for treating trichomoniasis, giardiasis, intestinal amebiasis, and amebic liver abscess (protozoal and anaerobic infections).

According to Presutti Laboratories, Inc. (Arlington Heights, Ill.), which plans to begin marketing 500-mg and 250-mg tablets of the drug in the third quarter of this year, it has few side effects and a long duration of action.

In clinical studies, treatment with a single 2-g dose of the drug (which is indicated for both females and their often asymptomatic male partners) was found effective in 92% to 100% of patients with trichomoniasis. Tindamax should be taken with food to minimize GI upset and patients should not drink alcohol for 3 days after taking the drug.

For more information, call 847-359-7800 or e-mail the company at presind@aol.com.

 

FDA approves premixed FSH cartridge for self-injection by infertility patients

The FDA has approved Follistim AQ Cartridge (follitropin beta injection), the first FSH treatment available in the US as a prefilled, premixed solution. The cartridge, designed for use only with the Follistim Pen, eliminates the need for women who are undergoing assisted reproductive treatments to mix one or more vials of medication themselves before self-administering the drug. Together with the pen device, the product takes the guesswork out of delivering accurate individualized doses of premixed follitropin beta injection (a prescription fertility drug made from recombinant DNA technology) and is more convenient and discreet. Follistim AQ Cartridge, with a unique dial-a-dose feature, is available from Organon USA Inc. in two strengths: 300 and 600 IU, providing multiple doses from a single cartridge. For more information, visit http://www.follistim.com .

 

Have mini U/S scanner, will travel

 

The FDA has granted 501(k) approval of the Mobilsonic VUE100, a mobile hand-held ultrasound scanner weighing less than 3 lb, according to Bierley Ultrasound (San Jose, Calif.), the leading distributor of Mobilsonic Inc. Despite its small size, the durable compact product performs the key functions of standard U/S machines. Its cost effectiveness makes it attractive to both large and small independent practices, says the distributor.

For more information, phone Jay Jinon at 1-408-224-8188 or contact him at jay@bierley.com.

Two products for pelvic floor repair

American Medical Systems Holdings, Inc., has announced FDA clearance of two of its products: the Apogee Vaginal Vault System and the Perigee Cystocele Repair System, both minimally invasive systems for repairing pelvic floor defects. AMS plans to begin physician training in preparation for commercial release of both systems later this year.

The Apogee system is used to repair vaginal vault prolapse using the IntePro or InteXen graft material. With Perigee, helical needles are used to introduce a supportive mesh to correct for the bladder's herniation through the vaginal wall. The Perigee system is designed to improve patient outcomes and reduce operating room time compared to traditional bladder prolapse repair techniques.

Physicians treating women for incontinence at the same time will be able to combine either new product with any one of the company's urinary incontinence products. For more information, visit the Web site at http://www.AmericanMedicalSystems.com .

CORRECTION

In the New Products department on page 32 of our May 2004 issue, we incorrectly stated that the second dose of Rhophylac usually given to Rh-negative women to prevent Rh sensitization is given 72 hours before giving birth if the baby is Rh-positive. The news brief should have read that a second dose is given to the woman within 72 hours of giving birth if her baby is Rh-positive.

 

New Products. Contemporary Ob/Gyn Jul. 1, 2004;49:104-106.