New Products

April 15, 2007

The latest in medical products for obstetrics and gynecology

Multimodality U/S system to feature 'smart software'

The product incorporates a high-resolution 17-inch LCD monitor with an articulated arm for optimal ergonomic viewing during the U/S exam. For more information, visit http:// http://www.MedisonUSA.com/.

The Food and Drug Administration has cleared MammaPrint, a new genetic test that helps predict if a woman's breast cancer will return 5 or 10 years down the line. Developed in the Netherlands (Agendia, Amsterdam), the test works by analyzing the activity level of 70 genes from a sample of a patient's tumor after the tumor is excised, and uses an algorithm to assign a numerical ranking. Although other tests to gauge breast cancer recurrence are already on the market, this was the first to seek FDA approval.

While far from foolproof, the test better predicts which women's cancers are not likely to spread versus those that are. An FDA spokesman cautioned that the "complex" test should be used carefully and only by experts. The test is designed to help physicians weed out those patients who might not need chemotherapy from those who need aggressive treatment.

Clearance was based on Agendia-submitted data from a study of 302 patients at five European centers. These studies confirmed that the test was useful in predicting time-to-distant metastasis in women younger than age 61 with stage I and stage II cancer, who were lymph-node negative, and had tumors of 5 cm or less. An FDA spokesman told the New York Times that 23% of women identified as high risk actually had a cancer recur within 5 years, while only 5% of low-risk women did.

Agendia hopes to market the test soon in the US, as it already does in the Netherlands. For more information, visit http:// http://www.fda.gov/ or http:// http://www.agendia.com/US/.

No more uncomfortable skin exits with updated TVT sling

The Gynecare TVT Secur System for treatment of stress urinary incontinence (SUI) features a polypropylene mesh implant that's one quarter as long as earlier slings, according to EthiconWomen's Health & Urology. The new sling system uses an "attach and release" mechanism to create stable placement and eliminate the discomfort of skin exits. Mechanical fixation is provided by absorbable fixation tips, made of polyglactin knitted mesh and polydioxanone suture yarn. A 10- to 15-minute procedure using local anesthesia is required for implantation. For more information, visit the company's Web site at http:// http://www.gynecare.com/.

New line of breast pumps for better breastfeeding experience